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Current consensus PPS: 45 to 79
https://www.marketscreener.com/zbcache/reuters/Fullscreen_Chart.php?p=6&RepNo=A25F6&codezb=8425&s=1&l=2
I would not be surprised to see a 55% upside soon towards the mean of the current consensus range and then to see price targets shift up further.
Was there any rumour to drive it up suddenly? Anything related to the latest conference transcript?
https://seekingalpha.com/article/4225252-arena-pharmaceuticals-inc-arna-ceo-amit-munshi-evercore-isi-healthconx-conference-transcript?page=4
1. "So we're still relatively light. We're just under 200 people inside the company."
small workforce. there was no discussion of returning to larger numbers of staff for the pipeline. The CEO made a point to show the portfolio is balanced across phases of development and therapeutic areas to appeal to a wide range of BP buyers.
2. "If this is a molecule developed at Merck or if it's a molecule developed in house at Janssen this would not be a normal question, right?"
There was a comparison to big pharma such Merck and Janssen, namely for ARNA to be treated similarly in terms of the lines of enquiry on the molecule. This is a clear message as to the quality of the molecules being developed. This is the company that delivered a safe weight loss medicine, Belviq, to Eisai which sets a precedent for future best in class therapies (https://medicalxpress.com/news/2018-08-weight-loss-drug-belviq-safe-heart.html). Obviously, United put the money on the table for PAH treatment (https://www.prnewswire.com/news-releases/arena-pharmaceuticals-and-united-therapeutics-announce-global-license-agreement-for-ralinepag-300751003.html). AbbVie is presenting at the same conference. This BP and several others should have the financial means for a double digit billion dollar acquisition.
https://www.fool.com/investing/2017/03/29/3-drugmakers-with-boatloads-of-cash-to-spend.aspx
Overall, the level is still flat for the past year with the lows drifting up slightly. This could be about to change with the move to Boston and as the days of the Belviq commercial failure due to the now completed 5 year post-approval study are now a thing of the past.
Hey just wondering why there's not much of a presence over here on IHUB - for ARNA, that is. Looks like Ivillage wants you to pay to chat. NO THANK YOU! ESPECIALLY SINCE YOU HAVE THIS WHINER SCOTTYxxx going on and on with his pre-adolescent rants. Yeah i will pay to post on a msgboard where Scotty is the most frequent contributor? Not happening. And just forget about Yahoo. So - why not just move the serious discussion over here to IHUB? I really want to talk about the last hour and a half of trading today... interpretation. And - that chart smith over on Ivillage - you REALLY should learn something about trade corrections that occur about 11 minutes after the close before you infer some serious meaning to After Hours Action!! OMG. Anyway - I would love to chat about how to interpret the area between 2:30PM and 4PM today (11/28). Not to mention all the rotten action earlier today and yesterday.
Arena Pharmaceuticals Expands Senior Management Team to Support Commercialization and Medical Affairs
SAN DIEGO, Nov. 26, 2018 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced the appointments of Robert Lisicki as Executive Vice President and Chief Commercial Officer, and Paul K. Audhya, MD, MBA, as Senior Vice President, Medical Affairs. Mr. Lisicki will report to Amit D. Munshi, Arena's President and Chief Executive Officer, and Dr. Audhya will report to Preston Klassen, MD, M.H.S., Executive Vice President, Research and Development and Chief Medical Officer. With these hires, Arena will be expanding its footprint into the Boston area.
"We believe three things are necessary to drive long-term success in a biotechnology organization: best-in-class products, sufficient capital to support the growth plan and a highly-skilled leadership team," said Munshi. "As we continue to strategically scale our team, our objective is to identify individuals with the passion, experience and ability to rapidly advance our business. Given Robert and Paul's extensive expertise in their respective areas of focus, we believe their appointments and the expansion into Boston significantly strengthen our ability to deliver transformational medicines to patients."
Mr. Lisicki brings over 20 years of experience in biopharmaceutical management, sales and marketing to Arena. Mr. Lisicki most recently served as General Manager, Vice President Cardio-Metabolic and Inflammation at Regeneron Pharmaceuticals, Inc. Prior to joining Regeneron, he was Senior Vice President of Sales and Marketing and Chief Customer Officer at Daiichi Sankyo, Inc. Prior to Daiichi Sankyo, Mr. Lisicki held several management positions at Amgen Inc., including Vice President and General Manager, responsible for a 700+ person sales force in the U.S. His U.S. leadership experiences included such market shaping products Enbrel and Prolia. During his tenure he also covered several ex-U.S. regions, and worked as an International Franchise Lead running the development and international strategies and business plans across Amgen's portfolio including Nephrology, Cardiology, Bone and Oncology. Prior to joining Amgen, Mr. Lisicki held various sales and marketing positions at Johnson & Johnson Corporation. Mr. Lisicki holds a Bachelor of Science degree in Finance and Business Administration from the State University of New York at Albany.
Dr. Audhya has over 20 years of clinical development and global medical affairs leadership experience across a range of therapeutic areas and disciplines, including rare disease. Most recently, he was Vice President, Global Strategy and Phase 4, Global Medical Affairs at Vertex Pharmaceuticals, Inc., where he led global launch and lifecycle management planning and implementation for the cystic fibrosis therapies portfolio. Prior to Vertex, Dr. Audhya was Vice President, Medical Affairs at Hospira Inc. (acquired by Pfizer) where he introduced transformational strategies for biosimilars globally and led the successful launch of the first monoclonal biosimilar in the EU. Prior to Hospira, Dr. Audhya held positions of increasing responsibility across all stages of drug development at Reata Pharmaceuticals (where he was Chief Medical Officer), Abbott Laboratories, Amgen, Bristol-Myers Squibb and Janssen. Dr. Audhya holds a Bachelor of Arts degree from New York University, an MD from New York University School of Medicine, and an MBA from the Graziadio School of Business and Management at Pepperdine University. He completed his residency in Internal Medicine at the University of Medicine and Dentistry of New Jersey and has authored numerous abstracts, posters, and more than 25 manuscripts.
About Arena Pharmaceuticals
Arena Pharmaceuticals is driven to deliver novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena's proprietary pipeline includes multiple potentially first- or best-in-class assets with broad clinical utility. Etrasimod (APD334), with potential utility in a broad range of immune and inflammatory conditions, is being evaluated in later-stage clinical programs in ulcerative colitis (UC) and Crohn's disease, as well as in programs for primary biliary cholangitis (PBC) and atopic dermatitis. Ralinepag (APD811) is being evaluated in a Phase 3 program for pulmonary arterial hypertension (PAH). Arena is also evaluating olorinab (APD371) in a Phase 2 program for gastrointestinal pain. Arena continues to assess other earlier research and development stage drug candidates, including APD418 for decompensated heart failure.
In addition, Arena has several partnerships including with Everest Medicines Limited (ralinepag and etrasimod in Greater China and select Asian countries), Axovant Sciences GmbH (nelotanserin - Phase 2), Boehringer Ingelheim International GmbH (undisclosed target - preclinical), Outpost Medicine, LLC (undisclosed target – preclinical), and Eisai Co., Ltd. and Eisai Inc. (BELVIQ® - marketed product).
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These forward-looking statements may be accompanied by words such as "will," "believe," "objective," "driven to," "potentially," "potential," or words of similar meaning, or they may be identified by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements include statements about the timing and significance of Mr. Lisicki and Dr. Audhya's appointment to the management team; Mr. Lisicki and Dr. Audhya's experience and their expected contribution; Arena's plans to expand its footprint in the Boston area; Arena's ability to drive long-term success and deliver transformational medicines to patients; and Arena's drive, focus, goals, strategy, clinical and research and development programs, and collaborations. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include: the timing and outcome of research, development and regulatory review is uncertain; clinical programs may not proceed at the time or in the manner expected or at all; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; and other risks related to developing and commercializing drugs; as well as those factors disclosed in Arena's filings with the Securities and Exchange Commission (SEC), including but not limited to Arena's Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, which was filed with the SEC on November 8, 2018. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Corporate Contact:
Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer
klind@arenapharm.com
858.210.3636
Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com
646.627.8384
Arena Pharmaceuticals to Participate in Upcoming Investor Conferences
SAN DIEGO, Calif., Nov. 20, 2018 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced that members of its senior management team will participate in two upcoming investor conferences:
Evercore ISI HealthCONx Conference – Presenting on Wednesday, November 28, at 4:15PM EST in Boston
Citi Global Healthcare Conference – Hosting investor meetings on Wednesday, December 5 and Thursday, December 6, in New York City
A live audio webcast of the presentation will be available under the investor relations section of Arena's website at www.arenapharm.com. A replay of the presentation will be available for 30 days following the event.
About Arena Pharmaceuticals
Arena Pharmaceuticals is driven to deliver novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena's proprietary pipeline includes multiple potentially first- or best-in-class assets with broad clinical utility. Etrasimod (APD334), with potential utility in a broad range of immune and inflammatory conditions, is being evaluated in later-stage clinical programs in ulcerative colitis (UC) and Crohn's disease, as well as in programs for primary biliary cholangitis (PBC) and atopic dermatitis. Ralinepag (APD811) is being evaluated in a Phase 3 program for pulmonary arterial hypertension (PAH). Arena is also evaluating olorinab (APD371) in a Phase 2 program for gastrointestinal pain. Arena continues to assess other earlier research and development stage drug candidates, including APD418 for decompensated heart failure.
In addition, Arena has several partnerships including with Everest Medicines Limited (ralinepag and etrasimod in Greater China and select Asian countries), Axovant Sciences GmbH (nelotanserin - Phase 2), Boehringer Ingelheim International GmbH (undisclosed target - preclinical), Outpost Medicine, LLC (undisclosed target – preclinical), and Eisai Co., Ltd. and Eisai Inc. (BELVIQ® - marketed product).
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These forward-looking statements may be accompanied by words such as "will," "driven to," "potentially," "potential," or words of similar meaning, or they may be identified by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements include, without limitation, statements about Arena's participation in the upcoming investor conferences and Arena's drive, focus, goals, strategy, clinical and research and development programs, and collaborations. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include that clinical and preclinical programs may not proceed at the time or in the manner expected or at all, as well as those factors disclosed in Arena's filings with the Securities and Exchange Commission (SEC), including but not limited to our Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, which was filed with the SEC on November 8, 2018. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Corporate Contact:
Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer
klind@arenapharm.com
858.210.3636
Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com
646.627.8384
Agreed that a run up looks possible very soon. The consensus PT has already been about 65 for some time and this should increase when clarification on the low double digit royalties from the latest deal are clarified to analysts.
Interesting to see Takeda pressing ahead with the expensive acquisition of Shire
https://www.fiercepharma.com/pharma/former-takeda-chairman-privately-opposes-shire-buyout-ft
but trying to sell off the Shire treatment for inflammatory bowel disease due to its previous acquisition:
https://pharmaphorum.com/news/takeda-proposes-selling-shires-ibd-treatment-after-merger/
The valuation of that sale could be a catalyst with respect to Etrasimod.
I see low 50’s as short term target. The significance of this deal has not fully sunk in with street analysts. Few PT increase have come in but I expect year end rally will take the stock much higher.
Arena Pharmaceuticals and United Therapeutics Announce Global License Agreement for Ralinepag
- Arena will receive $800M upfront, and is eligible to receive low double-digit tiered royalties, plus up to $400M in milestone payments
- United Therapeutics will receive exclusive, worldwide rights to ralinepag - a potential best-in-class agent for the treatment of pulmonary arterial hypertension
- Arena to host conference call and webcast today at 8:30 AM EST
SAN DIEGO and RESEARCH TRIANGLE PARK, N.C., Nov. 15, 2018 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) and United Therapeutics Corporation (Nasdaq: UTHR) today announced that the companies have entered into a global license agreement for Arena's Phase 3 investigational drug candidate, ralinepag, a next-generation, oral, selective and potent prostacyclin receptor agonist in development for the treatment of pulmonary arterial hypertension (PAH).
https://mma.prnewswire.com/media/436843/Arena_Pharmaceuticals_Logo.jpg
Under the terms of the agreement, Arena will grant United Therapeutics exclusive, worldwide rights to develop, manufacture and commercialize ralinepag. In return, Arena will receive up to $1.2 billion, including an upfront payment of $800 million and potential milestone payments totaling up to $400 million based on the achievement of certain regulatory events. Additionally, Arena will receive low double-digit tiered royalties on annual net sales of ralinepag.
"We believe ralinepag has the potential to transform the treatment of PAH," said Amit D. Munshi, President and Chief Executive Officer of Arena. "We are thrilled to partner with United Therapeutics, based on their long-standing, deep commitment to the PAH community. This transaction represents a significant milestone in the development of ralinepag and will strategically position Arena to aggressively advance our best-in-class pipeline, anchored by etrasimod and olorinab, with the focus and resources essential for long-term success."
"We are very impressed with the clinical development plan and FDA coordination being managed by Arena," said Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics. "We have conducted extensive due diligence on ralinepag, applying our two decades of knowledge about PAH. We are confident that after achieving FDA approval via at least one of its several different potential regulatory pathways to success, this product will help greater than 10,000 patients annually from the 2020s and well into the 2030s, while complementing our existing portfolio of PAH therapies."
The effectiveness of the agreement is conditioned on expiration or termination of the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and other customary closing conditions.
Arena Conference Call and Webcast
Arena will host a conference call and live webcast open to the public today, November 15, 2018, at 8:30 AM EST / 5:30 AM PST.
When: November 15, 2018, 8:30 AM EST / 5:30 AM PST
Dial-in: (877) 643-7155 (United States) or (914) 495-8552 (International)
Conference ID: 4484624
Please join the conference call at least 10 minutes early to register. You can access the live webcast under the investor relations section of Arena's website at: www.arenapharm.com. A replay of the conference call will be archived under the investor relations section of Arena's website for 30 days shortly after the call.
About Ralinepag
Ralinepag (APD811) is a next-generation, oral, selective potent, once-daily IP receptor agonist intended for the treatment of pulmonary arterial hypertension (PAH). Arena discovered and developed this drug candidate internally. Ralinepag's potency on vasodilation, inhibition of proliferation of vascular smooth muscle cells, and inhibition of platelet aggregation, combined with an extended half-life, support its application as a potentially best-in-class agent for the treatment of PAH.
Ralinepag is an investigational compound that is not approved for any use in any country.
About Arena Pharmaceuticals
Arena Pharmaceuticals is driven to deliver novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena's proprietary pipeline includes multiple potentially first- or best-in-class assets with broad clinical utility. Etrasimod (APD334), with potential utility in a broad range of immune and inflammatory conditions, is being evaluated in later-stage clinical programs in ulcerative colitis (UC) and Crohn's disease, as well as progressing programs for primary biliary cholangitis (PBC) and atopic dermatitis. Ralinepag (APD811) is being evaluated in a Phase 3 program for pulmonary arterial hypertension (PAH). Arena is also evaluating olorinab (APD371) in a Phase 2 program for gastrointestinal pain. Arena continues to assess other earlier research and development stage drug candidates, including APD418 for decompensated heart failure.
In addition, Arena has several partnerships including with Everest Medicines Limited (ralinepag and etrasimod in Greater China and select Asian countries), Axovant Sciences GmbH (nelotanserin - Phase 2), Boehringer Ingelheim International GmbH (undisclosed target - preclinical), Outpost Medicine, LLC (undisclosed target – preclinical), and Eisai Co., Ltd. and Eisai Inc. (BELVIQ® - marketed product).
About United Therapeutics
United Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our obsession with quality and innovation, the power of our brands, our entrepreneurial culture and our bioinformatics leadership. We also believe that our determination to be responsible citizens – having a positive impact on patients, the environment and society – will sustain our success in the long term.
Through our wholly-owned subsidiary, Lung Biotechnology PBC, we are focused on addressing the acute national shortage of transplantable lungs and other organs with a variety of technologies that either delay the need for such organs or expand the supply. Lung Biotechnology is the first public benefit corporation subsidiary of a public biotechnology or pharmaceutical company. [uthr-g]
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These forward-looking statements may be identified by introductory words such as "will," "eligible," "potential," "in development for," "we believe," "we are confident," "conditioned on," "can," "intended for," "potentially," "driven to," "being evaluated for," "evaluating," "focuses on," "are focused on," "estimate," "anticipate," "project," "forecast," "intend," or words of similar meaning, or by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements include, without limitation, statements about the license agreement between Arena and United Therapeutics, including its effectiveness, focus and potential payments to Arena; United Therapeutics' expertise and goals; the potential development, FDA approval and commercialization of ralinepag; the potential of ralinepag, including to be a best-in-class agent, to transform the treatment of PAH and to help greater than 10,000 patients annually from the 2020s and well into the 2030s; Arena's drive; the potential of Arena's assets, programs and collaborations; and United Therapeutics' focus, future and sustained long-term success. For such statements, Arena and United Therapeutics claim the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's and United Therapeutics' expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, without limitation, the following: the license agreement is subject to closing conditions, including regulatory approval, which may not be satisfied or occur; under the license agreement, United Therapeutics is not obligated to Arena to use any particular efforts to develop or commercialize ralinepag; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; nonclinical and clinical data are voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Arena, United Therapeutics or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; the timing and outcome of research, development and regulatory review is uncertain; the ability to obtain debt or other additional financing on favorable terms; Arena's expectations regarding the need to raise additional funds to advance all of its programs; you and others may not agree with the manner Arena and United Therapeutics allocate their resources; drug candidates may not advance in development or be approved for marketing; clinical trials and other studies may not proceed at the time or in the manner expected or at all; enrolling patients in ongoing and intended clinical trials is competitive and challenging; unexpected or unfavorable new data; risks related to developing and commercializing drugs, including regulatory, manufacturing and supply issues and the availability and use of ralinepag; risks and uncertainties relating to cash and revenues that may be generated from product sales or other sources, including the impact of competition; risks related to relying on partner performance; risks related to government and other third party actions, including decisions and other actions relating to approval, reimbursement and pricing; our and third parties' intellectual property rights; and satisfactory resolution of litigation or other disagreements with others. Additional factors that could cause actual results to differ materially from those stated or implied by forward-looking statements are disclosed in Arena's and United Therapeutics' filings with the Securities and Exchange Commission (SEC), including but not limited to our most recent Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. We are providing this information as of November 15, 2018, and Arena and United Therapeutics disclaim any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Arena Corporate Contact:
United Therapeutics Contact:
Kevin R. Lind
James Edgemond
Arena Pharmaceuticals, Inc.
United Therapeutics Corporation
Executive Vice President and
Chief Financial Officer & Treasurer
Chief Financial Officer
jedgemond@unither.com
klind@arenapharm.com
301.608.9292
858.210.3636
Arena Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com
646.627.8384
https://mma.prnewswire.com/media/785335/United_Therapeutics_Logo.jpg
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SOURCE Arena Pharmaceuticals, Inc.; United Therapeutics Corporation
Arena Inks $1.2 Billion Deal With United Therapeutics
https://seekingalpha.com/article/4222752-arena-inks-1_2-billion-deal-united-therapeutics
"Arena will be able to negotiate from a position of strength on any potential deal, whether for a drug candidate, a merger, or an outright buyout."
"the key thing to understand with Arena is that it is Etrasimod, not Ralinepag, that is the crown jewel of the pipeline."
"A deal involving Etrasimod or Arena itself could happen at any time..."
"The bottom line is that Arena is poised for something even bigger, and being on the sidelines is getting harder for any investor."
Arena Pharmaceuticals to Release Third Quarter 2018 Financial Results and Provide Corporate Update on November 7
SAN DIEGO, Oct. 31, 2018 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced that the Company will release its third quarter 2018 financial results and provide a corporate update on Wednesday, November 7, 2018, after the close of the U.S. financial markets. The Company will host a conference call and live webcast with the investment community the same day at 4:30 p.m. EST.
Conference Call & Webcast Information
When: November 7, 2018, 4:30 p.m. EST
Dial-in: (877) 643-7155 (United States) or (914) 495-8552 (International)
Conference ID: 1993206
Please join the conference call at least 10 minutes early to register. You can access the live webcast under the investor relations section of Arena's website at: www.arenapharm.com. A replay of the conference call will be archived under the investor relations section of Arena's website for 30 days after the call.
About Arena Pharmaceuticals
Arena Pharmaceuticals is driven to deliver novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena's proprietary pipeline includes multiple potentially first- or best-in-class assets with broad clinical utility. Ralinepag (APD811) is being evaluated in a Phase 3 program for pulmonary arterial hypertension (PAH). Etrasimod (APD334), with potential utility in a broad range of immune and inflammatory conditions, is being evaluated in later-stage clinical programs in ulcerative colitis (UC) and Crohn's disease, as well as progressing programs for primary biliary cholangitis (PBC) and atopic dermatitis. Arena is also evaluating olorinab (APD371) in a Phase 2 program for gastrointestinal pain. Arena continues to assess other earlier research and development stage drug candidates, including APD418 for decompensated heart failure.
In addition, Arena has several partnerships including with Everest Medicines Limited (ralinepag and etrasimod in Greater China and select Asian countries), Axovant Sciences GmbH (nelotanserin - Phase 2), Boehringer Ingelheim International GmbH (undisclosed target - preclinical), Outpost Medicine, LLC (undisclosed target – preclinical), and Eisai Co., Ltd. and Eisai Inc. (BELVIQ® - marketed product).
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about Arena's upcoming conference call and live webcast with the investment community, Arena's drive, and the potential of Arena's assets, programs, and collaborations. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include those disclosed in Arena's filings with the Securities and Exchange Commission. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Corporate Contact:
Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer
klind@arenapharm.com
858.210.3636
Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com
646.627.8384
https://mma.prnewswire.com/media/436843/Arena_Pharmaceuticals_Logo.jpg
https://c212.net/c/img/favicon.png?sn=LA57147&sd=2018-10-31 View original content to download multimedia:http://www.prnewswire.com/news-releases/arena-pharmaceuticals-to-release-third-quarter-2018-financial-results-and-provide-corporate-update-on-november-7-300740942.html
SOURCE Arena Pharmaceuticals, Inc.
ARENA PHARMACEUTICALS PRESENTED PHASE 2 CLINICAL DATA FOR ETRASIMOD IN ULCERATIVE COLITIS AT THE AMERICAN COLLEGE OF GASTROENTEROLOGY ANNUAL MEETING
SAN DIEGO, Oct. 8, 2018 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced that data from its OASIS Phase 2 clinical study for its investigational drug candidate etrasimod, a next-generation, oral, S1P receptor modulator with optimized activity being evaluated in ulcerative colitis (UC), were presented by Dr. William J. Sandborn at the American College of Gastroenterology Annual Meeting. The paper was awarded the 2018 ACG Auxiliary Award Recipient (Member).
"We are pleased to share data which we believe further support a direct readthrough to our Phase 3 program in UC. Our Phase 2 results demonstrated the potential of etrasimod to allow patients to achieve clinical remission and meaningful improvements in the endpoints measured," said Preston Klassen, MD, MHS, Executive Vice President, Research and Development and Chief Medical Officer of Arena. "We look forward to additional discussions with the regulatory agencies and moving rapidly into Phase 3."
These data will also be presented at the United European Gastroenterology Week (UEGW) in Vienna later this month.
Presentation Details
Title: A Randomized, Double-Blind, Placebo-Controlled Trial of a Selective, Oral Sphingosine 1-Phosphate (S1P) Receptor Modulator, Etrasimod (APD334), in Moderate to Severe Ulcerative Colitis (UC): Results From the OASIS Study
When: Monday, October 8, 2018, 2:15 PM - 2:25 PM EDT
About Etrasimod
Etrasimod (APD334), is a next generation, oral, selective sphingosine 1 phosphate (S1P) receptor modulator, discovered by Arena, designed to provide systemic and local cell modulation by selectively targeting S1P receptor subtypes 1,4 and 5. Etrasimod has therapeutic potential in immune and inflammatory-mediated diseases such as ulcerative colitis, Crohn's disease, primary biliary cholangitis (PBC) and atopic dermatitis. S1P receptors have been demonstrated to be involved in the modulation of several biological responses, including lymphocyte trafficking from lymph nodes to the peripheral blood. By isolating subpopulations of lymphocytes in lymph nodes, fewer immune cells are available in the circulating blood to effect tissue damage.
Etrasimod is an investigational compound that is not approved for any use in any country.
About Arena Pharmaceuticals
Arena Pharmaceuticals is focused on delivering novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena's proprietary pipeline includes multiple potentially first- or best-in-class programs with broad clinical utility. The most advanced investigational clinical programs are ralinepag (APD811), in a Phase 3 program for pulmonary arterial hypertension (PAH), and etrasimod (APD334), expected to commence a Phase 3 program for ulcerative colitis (UC) and a program in Crohn's disease (CD), and which has potential utility for a broad range of immune and inflammatory-mediated. Arena is also evaluating olorinab (APD371) for the treatment of gastrointestinal pain, as well as other drug candidates in earlier research and development stages.
In addition, Arena has several collaborations including with Everest Medicines Limited (ralinepag and etrasimod in Greater China and select Asian countries), Axovant Sciences GmbH (nelotanserin - Phase 2), Boehringer Ingelheim International GmbH (undisclosed target - preclinical), Outpost Medicine, LLC (undisclosed target – preclinical), and Eisai Co., Ltd. and Eisai Inc. (BELVIQ® - marketed product).
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These forward-looking statements may be accompanied by words such as "potentially," "focused on," "expected," "next-generation," or words of similar meaning, or they may be identified by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements include, without limitation, statements about the following: the opportunity and potential of etrasimod and Arena's other investigational drug candidates, including to be first- or best-in-class; the significance of Phase 2 data; discussions with regulatory agencies; and the Phase 3 clinical programs for etrasimod, including about timing; and Arena's focus, goals, strategy, clinical programs and collaborations. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include: results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; nonclinical and clinical data are voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Arena or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; the timing and outcome of research, development and regulatory review is uncertain; we expect to need additional funds to advance all of our programs, and you and others may not agree with the manner we allocate our resources; clinical trials and other studies may not proceed at the time or in the manner expected or at all; enrolling patients in our ongoing and intended clinical trials is competitive and challenging; our drug candidates may not advance in development or be approved for marketing; unexpected or unfavorable new data; risks related to developing and commercializing drugs; risks related to relying on partners and other third parties; Arena's and third parties' intellectual property rights; and satisfactory resolution of litigation or other disagreements with others. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the Securities and Exchange Commission (SEC), including but not limited to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, which was filed with the SEC on August 7, 2018. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Corporate Contact:
Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer
klind@arenapharm.com
858.210.3636
Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com
646.627.8384
October 4th is R&D Day
Arena has been hyping the day. I wonder if they will have new announcements. Seems like they will have some new info. If they only give timelines on upcoming trials then that will be a dud.
Based on the October 2nd investor conference sessions, Olorinab is something that surpassed their expectations.
GLTA!
Arena Pharmaceuticals Reports Positive Long-Term Data from the Ongoing Open-Label Extension of the Phase 2 Trial Evaluating Ralinepag for Treatment of Pulmonary Arterial Hypertension
- Ralinepag demonstrated durable, long-term improvements in both PVR and 6MWD
- Favorable long-term tolerability profile demonstrated
SAN DIEGO, Oct. 2, 2018 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced positive data from a planned interim analysis of the ongoing open-label extension of the Phase 2 trial of its investigational drug candidate ralinepag, a next-generation, oral, selective and potent prostacyclin receptor agonist in development for the treatment of pulmonary arterial hypertension (PAH).
Open-Label Extension of Phase 2 Trial Design
This is an open-label extension study evaluating the long-term safety, tolerability and efficacy of ralinepag in 45 patients (85% of study completers) who completed the Phase 2 randomized study. In the extension study, patients originally randomized to ralinepag continued on active therapy (N=30); patients randomized to placebo switched to ralinepag (N=15). Key efficacy measurements include pulmonary vascular resistance (PVR) and 6-minute walk distance (6MWD).
Key Efficacy and Safety Measurements
Patients who continued on ralinepag in the open-label extension had a median treatment duration of 1.8 years (range 1.2-3.4 years) at the time of right heart catheterization (RHC). In these patients, sustained improvements from baseline in the original study were observed for PVR (219 dyn*s*cm -5 median reduction, p = 0.002) and 6MWD (49.8 meters mean improvement; p = 0.003). Patients switching from placebo to active drug had a median ralinepag treatment duration of 1.4 years (range 0.9-2.3 years) at the time of RHC. In these patients, a similar magnitude of improvement was observed for PVR (214 dyn*s*cm -5 median reduction, p = 0.206) and 6MWD (69.8 meters mean improvement; p = 0.010). In both groups, these long-term changes in PVR and 6MWD were observed in a population where the majority of patients were already receiving dual combination PAH background therapy.
Adverse events (AEs) observed in this extension study were consistent with the known profile of prostacyclin therapies for the management of PAH, with headache and nausea being the most commonly reported. Among patients who continued ralinepag in the open-label extension, the incidence rate of AEs was lower relative to the randomized Phase 2 study, suggesting that AEs related to tolerability are reduced after initial drug titration.
"We are pleased with the long-term safety, tolerability and efficacy that ralinepag has demonstrated in the open-label extension of our Phase 2 trial. This is the first time an oral prostacyclin has shown durable, long-term improvements on hemodynamic and functional measures. Patients continuing ralinepag from the original study clearly maintained improvements in PVR and 6MWD. Those patients switching from placebo to ralinepag in this extension trial demonstrated a similar magnitude of effect on PVR and 6MWD, although the smaller sample size limits some of the statistical comparisons. These data reinforce our belief that PAH patients can truly benefit from ralinepag's improved receptor potency and extended pharmacokinetics," said Preston Klassen, MD, MHS, Executive Vice President, Research and Development and Chief Medical Officer of Arena. "Ralinepag has the potential to offer the pharmacokinetic and pharmacodynamic advantages of continuously infused IV prostacyclin with the ease of a once-daily oral tablet."
"It is encouraging to gain additional insight into the long-term safety and efficacy of ralinepag. I look forward to seeing data from the Phase 3 ADVANCE program and the effect that ralinepag may have when added to PAH standard of care," said Vallerie McLaughlin, M.D., Kim A. Eagle MD Endowed Professor of Cardiovascular Medicine at the University of Michigan and Director of the Pulmonary Hypertension Program1. "These data validate progress towards bringing a new therapeutic option to patients suffering from PAH, a devastating disease with significant unmet medical need despite available treatments."
About Ralinepag
Ralinepag (APD811) is a next-generation, oral, selective potent, once-daily IP receptor agonist intended for the treatment of pulmonary arterial hypertension (PAH). Arena discovered and developed this drug candidate internally. Ralinepag's potency on vasodilation, inhibition of proliferation of vascular smooth muscle cells, and inhibition of platelet aggregation, combined with an extended half-life, support its application as a potentially best-in-class agent for the treatment of PAH.
Ralinepag is an investigational compound that is not approved for any use in any country.
About Arena Pharmaceuticals
Arena Pharmaceuticals is focused on delivering novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena's proprietary pipeline includes multiple potentially first- or best-in-class programs with broad clinical utility. The most advanced investigational clinical programs are ralinepag (APD811), in a Phase 3 program for pulmonary arterial hypertension (PAH), and etrasimod (APD334), expected to commence a Phase 3 program for ulcerative colitis (UC) and a program in Crohn's disease (CD), and which has potential utility for a broad range of immune and inflammatory conditions. Arena is also evaluating olorinab (APD371) for the treatment of gastrointestinal pain, as well as other drug candidates in earlier research and development stages.
In addition, Arena has several collaborations including with Everest Medicines Limited (ralinepag and etrasimod in Greater China and select Asian countries), Axovant Sciences GmbH (nelotanserin - Phase 2), Boehringer Ingelheim International GmbH (undisclosed target - preclinical), Outpost Medicine, LLC (undisclosed target – preclinical), and Eisai Co., Ltd. and Eisai Inc. (BELVIQ® - marketed product).
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These forward-looking statements may be identified by introductory words such as "in development for," "evaluating," "suggesting," "belief," "can," "potential," "look forward to," "may," "progress towards," "intended for," "potentially," "focused on," "expected," "evaluating," or words of similar meaning, or by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements include, without limitation, statements regarding the intention and plan to progress ralinepag's development; the potential for reduced adverse events related to tolerability after initial drug titration; ralinepag's potential, including the potential for its potency and pharmacokinetics to offer benefits to patients, its potential to offer the pharmacokinetic and pharmacodynamic advantages of continuously infused IV prostacyclin with the ease of a once-daily oral tablet, and its potential to bring a new therapeutic option to patients suffering with unmet medical need; the potential of Arena's compounds in its pipeline, including to be first- or best-in-class programs and their utility; and Arena's focus, goals, strategy, clinical programs and collaborations. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include the following: the announced data are based on an interim analysis of certain key measurements, and such interim data or analysis may change following a more comprehensive review of the data, and such interim data or analysis may not accurately reflect the final results of the study; the reported-on trial was not a placebo-controlled study; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; nonclinical and clinical data are voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Arena or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; the timing and outcome of research, development and regulatory review is uncertain; we expect to need additional funds to advance all of our programs, and you and others may not agree with the manner we allocate our resources; our drug candidates may not advance in development or be approved for marketing; clinical trials and other studies may not proceed at the time or in the manner expected or at all; enrolling patients in our ongoing and intended clinical trials is competitive and challenging; unexpected or unfavorable new data; risks related to developing and commercializing drugs; risks related to relying on partners and other third parties; Arena's and third parties' intellectual property rights; and satisfactory resolution of litigation or other disagreements with others. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the Securities and Exchange Commission (SEC), including but not limited to Arena's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
1 Dr. McLaughlin receives consulting fees from Arena.
Corporate Contact:
Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer
klind@arenapharm.com
858.210.3636
Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com
646.627.8384
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SOURCE Arena Pharmaceuticals, Inc.
Added a few more to the stash, patience. Buyout could be over 70+, ya just never know with bio’s. $$$$
Arena Pharmaceuticals Reports Positive Phase 2a Results for Olorinab in Patients with Abdominal Pain Associated with Crohn's Disease
- Olorinab demonstrated a statistically significant improvement in abdominal pain over 8 weeks of treatment
- All patients with evaluable data at week 8 exhibited a pre-defined clinical response of ≥30% change from baseline in AAPS
- Treatment effects were demonstrated early and were consistent over the 8-week treatment period
- Olorinab appeared safe and generally well tolerated
- Arena intends to progress the olorinab clinical program targeting gastrointestinal pain
SAN DIEGO, Sept. 24, 2018 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced positive topline results from its Phase 2a trial of olorinab, an investigational, peripherally restricted, highly selective, full agonist of the cannabinoid receptor 2 (CB2) in development for the treatment of gastrointestinal pain.
Phase 2a Trial Design
This was a randomized, open-label, 8-week study investigating two doses of olorinab (25 mg and 100 mg) administered TID (three times daily). All patients were diagnosed with quiescent to mild active Crohn's disease associated with chronic abdominal pain defined as a baseline Average Abdominal Pain Score (AAPS) ≥4. Fourteen patients were enrolled with a mean baseline AAPS of 5.6.
Topline Analyses
Reductions in pain were seen within the first week of treatment with olorinab and statistically significant improvement from baseline in AAPS was observed at weeks 4 and 8. In the 11 patients evaluable at 8 weeks of treatment (baseline AAPS of 6.0), there was an improvement in AAPS of -4.6 (p<0.001) from baseline at peak effect (1.5 hours post morning dose). At peak effect, 11 out of 13 patients (85%) with evaluable data at week 4, and 11 out of 11 patients (100%) with evaluable data at week 8, exhibited a clinically relevant improvement (≥30% change from baseline) in AAPS. Results in all patients randomized (intent-to-treat) demonstrated 11 out of 14 patients (79%) with clinically relevant improvement at both weeks 4 and 8. The improvement in pain was consistent at both the 25 mg and 100 mg olorinab dose levels and a statistically significant improvement in AAPS was also observed at trough levels (before the morning dose).
Olorinab appeared safe and generally well tolerated in this study with no clinically significant changes in heart rate or blood pressure, no psychotropic effects, and no discontinuations due to adverse events.
"There is a strong clinical need for non-opiate treatments for the management of chronic abdominal pain in patients with gastrointestinal disorders, including Crohn's disease, ulcerative colitis and irritable bowel syndrome," stated Bruce Yacyshyn, MD, Professor Medicine in the Division of Digestive Diseases at the University of Cincinnati College of Medicine and Medical Director for Inpatient Gastroenterology at UC Health University Hospital. "The exciting results from this initial Phase 2a study in patients with Crohn's disease leaves me optimistic for the potential of olorinab as a novel approach for the management of GI pain. I look forward to the further development of this interesting compound as an aid in the management of this complex group of patients."
Preston Klassen, MD, MHS, Chief Medical Offer of Arena, said, "The intent of this Phase 2a study of olorinab was to get directional information on the safety, tolerability and therapeutic potential to reduce gastrointestinal pain in patients with Crohn's disease and symptoms of chronic abdominal pain. Despite its small size and uncontrolled design, this trial provides early results that suggest a robust clinical response and supports continued, rapid development of olorinab, potentially targeting several diseases in which gastrointestinal pain is a hallmark. We look forward to providing additional detail on the development path forward during Arena's R&D Day on October 4th."
About the Trial
The Phase 2a study was a randomized, open-label, 8-week trial to assess the safety, tolerability, efficacy and pharmacokinetics of two orally administered doses (25 mg and 100 mg TID) of olorinab (APD371) in patients with Crohn's disease experiencing abdominal pain. The trial enrolled 14 patients with an Average Abdominal Pain Score (AAPS) ≥4. The safety assessment included adverse events, physical examination, clinical laboratory tests (including hematology, serum chemistry and urinalysis), ECGs and vital signs monitored throughout the study. The efficacy assessment included change in AAPS from baseline, and proportion of responders (defined as a >30% improvement in AAPS) determined at three time points (before the morning dose of olorinab, 1.5 hours after the morning dose, and before the evening dose) throughout the study. In addition, the impact of 8 weeks treatment with olorinab on inflammatory markers of Crohn's disease and Patient Reported Outcomes/Health Questionnaires was assessed.
About Olorinab
Olorinab (APD371) is an oral, peripherally restricted, highly selective, full agonist of the cannabinoid receptor 2 (CB2) in development for the treatment of gastrointestinal-based visceral pain associated with gastrointestinal diseases, including Crohn's disease. Arena discovered and developed this drug candidate internally. Olorinab showed sustained efficacy in several preclinical models of chronic pain (including inflammatory bowel disease) and appeared safe and well tolerated in Phase 1 single and multiple dose studies. In a Phase 1 study of healthy volunteers, olorinab produced no psychotropic effects commonly seen with cannabinoids, supporting its potential application as an analgesic without risk of abuse or dependence.
Olorinab is an investigational compound that is not approved for any use in any country.
About Arena Pharmaceuticals
Arena Pharmaceuticals is focused on delivering novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena's proprietary pipeline includes multiple potentially first- or best-in-class programs with broad clinical utility. The most advanced investigational clinical programs are ralinepag (APD811), in a Phase 3 program for pulmonary arterial hypertension (PAH), and etrasimod (APD334), expected to commence a Phase 3 program for ulcerative colitis (UC) and a program in Crohn's disease (CD), and which has potential utility for a broad range of immune and inflammatory conditions. Arena is also evaluating olorinab (APD371) for the treatment of gastrointestinal pain, as well as other drug candidates in earlier research and development stages.
In addition, Arena has several collaborations including with Everest Medicines Limited (ralinepag and etrasimod in Greater China and select Asian countries), Axovant Sciences GmbH (nelotanserin - Phase 2), Boehringer Ingelheim International GmbH (undisclosed target - preclinical), Outpost Medicine, LLC (undisclosed target – preclinical), and Eisai Co., Ltd. and Eisai Inc. (BELVIQ® - marketed product).
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These forward-looking statements may be identified by introductory words such as "intends," "potential," "look forward to," "focused on," "evaluating," "expected," or words of similar meaning, or by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements include, without limitation, statements regarding the intention and plan to progress olorinab's development; the need for non-opiate treatments; the importance of olorinab's Phase 2a results and data; olorinab's potential; plans to provide additional details; the potential of Arena's compounds in its pipeline, including to be first- or best-in-class programs and their utility; and Arena's focus, goals, strategy, clinical programs and collaborations. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include the following: the topline data is based on preliminary analysis of key data, and such data or analysis may change following a more comprehensive review of the data, and such topline data may not accurately reflect the complete results of a particular study or trial; the reported on Phase 2a trial was not a placebo controlled study; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; nonclinical and clinical data are voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Arena or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; the timing and outcome of research, development and regulatory review is uncertain; we expect to need additional funds to advance all of our programs, and you and others may not agree with the manner we allocate our resources; our drug candidates may not advance in development or be approved for marketing; clinical trials and other studies may not proceed at the time or in the manner expected or at all; enrolling patients in our ongoing and intended clinical trials is competitive and challenging; unexpected or unfavorable new data; risks related to developing and commercializing drugs; risks related to relying on partners and other third parties; Arena's and third parties' intellectual property rights; and satisfactory resolution of litigation or other disagreements with others. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the Securities and Exchange Commission (SEC), including but not limited to Arena's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Corporate Contact:
Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer
klind@arenapharm.com
858.210.3636
Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com
646.627.8384
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SOURCE Arena Pharmaceuticals, Inc.
The news out after hours is a big one!
This is going to rocket up this week. Can't wait.
ARNA management is setting the table. Seems like O data is going to rock - but who can tell for sure? It is an open label study. Only O involved, so it would be a surprise if they pump the data release so much and data is bad.
I am thinking they will release data prior to market open on Monday October 1st. Should be fun. Let's see what happens....
Arena Pharmaceuticals Presents Preclinical Data for Olorinab at International Association for the Study of Pain World Congress
SAN DIEGO, Sept. 17, 2018 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced that results from preclinical studies of its investigative drug candidate olorinab, a peripherally restricted, highly selective, full agonist of the cannabinoid receptor 2 (CB2) in development for the treatment of visceral pain associated with Crohn's disease, were presented at the International Association for the Study of Pain (IASP) World Congress in Boston, MA.
"We are pleased to present data supporting olorinab's antinociceptive effects in visceral sensory pathways," said Preston Klassen, MD, MHS, Executive Vice President, Research and Development and Chief Medical Officer of Arena. "Through its full-agonism and selectivity, we believe olorinab may provide a novel therapeutic approach for sustained relief of visceral pain without psychotropic effects, potentially providing a new treatment option without the risk for dependence or abuse. We are currently evaluating olorinab in a Phase 2 clinical trial in IBD-associated abdominal pain and expect the availability of topline data by the end of the third quarter."
Presentation Details
Poster Abstract Title: APD371, a Peripherally Restricted, Highly Selective, Full Agonist of the Cannabinoid Receptor 2 (CB2) Receptor, Reduces Colitis-Induced Visceral Hypersensitivity in Rats
Poster Number: PFR455
Presentation Date: Friday, September 14
About Arena Pharmaceuticals
Arena Pharmaceuticals is focused on delivering novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena's proprietary pipeline includes multiple potentially first- or best-in-class programs with broad clinical utility. The most advanced investigational clinical programs are ralinepag (APD811), in a Phase 3 program for pulmonary arterial hypertension (PAH), and etrasimod (APD334), expected to commence a Phase 3 program for ulcerative colitis (UC) and a program in Crohn's disease (CD), and which has potential utility for a broad range of immune and inflammatory conditions. Arena is also evaluating olorinab (APD371) in a Phase 2 study for the treatment of visceral pain associated with Crohn's disease, as well as other drug candidates in earlier research and development stages.
In addition, Arena has several collaborations including Everest Medicines Limited (ralinepag and etrasimod in Greater China and select Asian countries), Axovant Sciences GmbH (nelotanserin - Phase 2), Boehringer Ingelheim International GmbH (undisclosed target - preclinical), Outpost Medicine, LLC (undisclosed target – preclinical), and Eisai Co., Ltd. and Eisai Inc. (BELVIQ® - marketed product).
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These forward-looking statements may be accompanied by words such as "believe," "may," "potentially," "expect," "focused on," "potential," or words of similar meaning, or they may be identified by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements include, without limitation, statements about the following: the potential of olorinab, including with respect to its efficacy, side effects, and risks; the availability of topline Phase 2 data for olorinab; and Arena's focus, goals, strategy, proprietary pipeline and collaborations. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the following: we may need additional funds to advance all of our programs, and you and others may not agree with the manner we allocate our resources; risks related to developing and commercializing drugs; enrolling patients in our ongoing and intended clinical trials is competitive and challenging; clinical programs may not proceed at the time or in the manner expected or at all; the timing and outcome of research, development and regulatory review is uncertain, and our drug candidates may not advance in development or be approved for marketing; risks and uncertainties relating to cash and revenues that may be generated from product sales or other sources, including the impact of competition; Arena's revenues are based in part on estimates, judgment and accounting policies, and inaccuracies or disagreement on these subjects may result in changes to Arena's guidance or previously reported results; risks related to unexpected or unfavorable new data; nonclinical and clinical data is voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Arena or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; topline data may not accurately reflect the complete results of a particular study or trial; satisfactory resolution of litigation or other disagreements with others; government and third-party payor actions, including relating to reimbursement and pricing; risks related to relying on collaborative arrangements; the entry into or modification or termination of collaborative arrangements; and Arena's and third parties' intellectual property rights. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the Securities and Exchange Commission (SEC), including but not limited to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, which was filed with the SEC on August 7, 2018. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Corporate Contact:
Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer
klind@arenapharm.com
858.210.3636
Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com
646.627.8384
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SOURCE Arena Pharmaceuticals, Inc.
ARNA Management just announced they are going to be attending investor conferences next week.
Hmmmm..... let's see.... Olorinab was an 8-week trial which was to be fully enrolled about 10 weeks ago. Now there is a hasty decision to attend these investor conferences. Seems to me that there may good news on the O front. Let's watch.
https://www.prnewswire.com/news-releases/arena-pharmaceuticals-to-present-at-upcoming-investor-conferences-300704422.html
Arena Pharmaceuticals Presented Phase 1 Clinical Data for Ralinepag in Pulmonary Arterial Hypertension at the European Society of Cardiology
SAN DIEGO, Aug. 28, 2018 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced that data from two Phase 1 clinical studies evaluating an extended-release (XR) formulation of its investigative drug candidate ralinepag, a next-generation, oral, selective and potent prostacyclin receptor agonist in development for the treatment of pulmonary arterial hypertension (PAH), were presented by Dr. John Adams, PhD at the European Society of Cardiology Congress on August 27.
Data from these Phase 1 clinical studies indicate that the ralinepag XR tablet formulation offers improved pharmacokinetic (PK) performance over selexipag and its active metabolite, MRE-269, by providing an extended effective half-life (28-29 hrs) and maintaining low peak–trough fluctuation with oncedaily dosing.
"With an extended half-life and low peak-to-trough fluctuation, the ralinepag XR tablet closely approximates the PK profile of continuously infused IV-prostacyclin," said Preston Klassen, MD, MHS, Chief Medical Offer of Arena. "These highly favorable and desirable PK characteristics further support the use of the ralinepag XR tablet in the ADVANCE Phase 3 clinical program."
Presentation Details
Title: Relative bioavailability and pharmacokinetic (PK) performance of a ralinepag extended-release (XR) tablet oral formulation and the effect of food and gender in healthy human subjects
Abstract number: 3022
About Ralinepag
Ralinepag (APD811) is a next-generation, oral, selective potent, once-daily IP receptor agonist intended for the treatment of pulmonary arterial hypertension (PAH). Arena discovered and developed this drug candidate internally. Ralinepag's potency on vasodilation, inhibition of proliferation of vascular smooth muscle cells, and inhibition of platelet aggregation, combined with an extended half-life, support its application as a potentially best-in-class agent for the treatment of PAH.
Ralinepag is an investigational compound that is not approved for any use in any country.
About Arena Pharmaceuticals
Arena Pharmaceuticals is focused on delivering novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena's proprietary pipeline includes multiple potentially first- or best-in-class programs with broad clinical utility. The most advanced investigational clinical programs are ralinepag (APD811), in a Phase 3 program for pulmonary arterial hypertension (PAH), and etrasimod (APD334), expected to commence a Phase 3 program for ulcerative colitis (UC) and a program in Crohn's disease (CD), and which has potential utility for a broad range of immune and inflammatory conditions. Arena is also evaluating olorinab (APD371) in a Phase 2 study for the treatment of visceral pain associated with Crohn's disease, as well as other drug candidates in earlier research and development stages.
In addition, Arena has several collaborations including Everest Medicines Limited (ralinepag and etrasimod in Greater China and select Asian countries), Axovant Sciences GmbH (nelotanserin - Phase 2), Boehringer Ingelheim International GmbH (undisclosed target - preclinical), Outpost Medicine, LLC (undisclosed target – preclinical), and Eisai Co., Ltd. and Eisai Inc. (BELVIQ® - marketed product).
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These forward-looking statements may be accompanied by words such as "potentially," "focused on," "expected," or words of similar meaning, or they may be identified by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements include, without limitation, statements about the following: the opportunity and potential of etrasimod and ralinepag, including to improve the treatment of patients, to meet unmet medical needs, to deliver broad utility across a range of immune and inflammatory conditions, to be best-in-class, and, in the case of ralinepag, to approximate the pharmacokinetic advantages of continuously infused IV prostacyclin with the ease of a once-daily oral; the ongoing and planned clinical programs for ralinepag and etrasimod, including Arena's ability and timing to initiate, enroll, and complete trials and announce clinical data; and Arena's focus, goals, strategy, clinical programs and collaborations. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include that clinical programs may not proceed at the time or in the manner expected or at all, as well as those factors disclosed in Arena's filings with the Securities and Exchange Commission (SEC), including but not limited to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, which was filed with the SEC on August 7, 2018. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Corporate Contact:
Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer
klind@arenapharm.com
858.210.3636
Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com
646.627.8384
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SOURCE Arena Pharmaceuticals, Inc.
Arena Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2018 Financial Results
- Initiated ADVANCE Phase 3 Program for Ralinepag in Pulmonary Arterial Hypertension (PAH)
- Completed Enrollment for Olorinab Study for Pain Associated with Crohn's Disease; Data in Q3:18
- Submitted Etrasimod Meeting Request to the FDA for Ulcerative Colitis (UC)
SAN DIEGO, Aug. 6, 2018 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today provided a corporate update and reported financial results for the second quarter ended June 30, 2018.
"We have made significant progress over the past three months across our clinical programs, including the initiation of our ADVANCE Phase 3 program for ralinepag in patients with PAH. We are excited for the opportunity to potentially advance the treatment paradigm for patients suffering from this critical illness," said Amit D. Munshi, President and CEO of Arena. "Additionally, we are pleased to have submitted our meeting request to the FDA for etrasimod in UC, and look forward to the data readout from our Phase 2 study of olorinab for pain associated with Crohn's disease in September."
Pipeline Update
Etrasimod – Next generation, oral, selective sphingosine-1-phosphate (S1P) receptor modulator intended for the potential treatment of multiple immune and inflammatory diseases
Ulcerative colitis (UC):
Crohn's disease (CD):
Primary biliary cholangitis (PBC):
Ralinepag – Next generation, oral, once-daily, selective prostacyclin receptor agonist intended for the potential treatment of pulmonary arterial hypertension (PAH)
Initiating three Phase 3 trials for the most comprehensive PAH clinical program
Open-label extension interim trial results expected in H2:18
Olorinab – Peripherally restricted, oral, full agonist of the cannabinoid 2 (CB2) receptor intended for the potential treatment of visceral pain, specifically pain associated with Crohn's disease
Completed enrollment in Phase 2 study in June, data expected in late September
Collaboration Update
In July 2018, Everest Medicines Ltd. submitted Investigational New Drug applications to the China Food and Drug Administration to initiate Phase 1 studies for etrasimod and ralinepag
In July 2018, Eisai Inc. reported positive topline results from CAMELLIA-TIMI61, a cardiovascular outcome trial for the anti-obesity agent BELVIQ®
In April 2018, Arena announced a licensing agreement with Outpost Medicine on a preclinical compound for the treatment of genitourinary disorders
Corporate Update
On October 4, 2018, Arena expects to host an Analyst and Investor Day in New York City
In July 2018, Arena appointed Kieran T. Gallahue as a non-executive director
Financial Update
Second Quarter 2018 Financial Results
Revenues totaled $4.0 million, consisting of $3.1 million in collaboration revenue, and $0.9 million in royalty revenue
Research and development expenses totaled $26.8 million
General and administrative expenses totaled $10.4 million
Net loss attributable to stockholders of Arena was $31.8 million, or $0.65 per share
At June 30, 2018, Arena's cash, cash equivalents and investments balance was $592.4 million and approximately 49.3 million shares of Arena common stock were outstanding.
Conference Call & Webcast Information
Arena will host a conference call and live webcast with the investment community today, Monday, August 6, 2018, at 4:30 p.m. EDT to discuss the financial results and provide a corporate update.
When: Monday, August 6, 2018, at 4:30 p.m. EDT
Dial-in: (877) 643-7155 (United States) or (914) 495-8552 (International)
Conference ID: 5986018
Please join the conference call at least 10 minutes early to register. You can access the live webcast under the investor relations section of Arena's website at: www.arenapharm.com. A replay of the conference call will be archived under the investor relations section of Arena's website for 30 days shortly after the call.
About Arena Pharmaceuticals
Arena Pharmaceuticals is focused on delivering novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena's proprietary pipeline includes multiple potentially first- or best-in-class programs with broad clinical utility. The most advanced investigational clinical programs are ralinepag (APD811), in a Phase 3 program for pulmonary arterial hypertension (PAH), and etrasimod (APD334), expected to commence a Phase 3 program for ulcerative colitis (UC) and a program in Crohn's Disease (CD), and which has potential utility for a broad range of immune and inflammatory conditions. Arena is also evaluating olorinab (APD371) in a Phase 2 study for the treatment of visceral pain associated with Crohn's disease, as well as other drug candidates in earlier research and development stages.
In addition, Arena has several collaborations including Everest Medicines Limited (ralinepag and etrasimod in Greater China and select Asian countries), Axovant Sciences GmbH (nelotanserin - Phase 2), Boehringer Ingelheim International GmbH (undisclosed target - preclinical), Outpost Medicine, LLC (undisclosed target – preclinical), and Eisai Co., Ltd. and Eisai Inc. (BELVIQ® - marketed product).
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements may be identified by words such as "look forward to," "intended," "potential," "planning," "expect," "expected," "expects," "will," and "focused on," and include, without limitation, statements about the following: design, initiation, enrollment, results, data readouts and timing relating to ongoing and intended clinical trials, such as statements about the timing of data from the open-label extension study of ralinepag, data from the Phase 2 trial of olorinab, and initiation and enrollment of the planned Phase 3 trials of ralinepag; the potential of Arena's drug candidates; Arena's upcoming Analyst and Investor Day; Arena's investment community conference call and webcast; and Arena's focus, goals, strategy, clinical programs, and collaborators. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the following: we may need additional funds to advance all of our programs, and you and others may not agree with the manner we allocate our resources; risks related to developing and commercializing drugs; enrolling patients in our ongoing and intended clinical trials is competitive and challenging; clinical trials and other studies may not proceed at the time or in the manner expected or at all; the timing and outcome of research, development and regulatory review is uncertain, and our drug candidates may not advance in development or be approved for marketing; risks and uncertainties relating to cash and revenues that may be generated from product sales or other sources, including the impact of competition; Arena's revenues are based in part on estimates, judgment and accounting policies, and incorrect estimates or disagreement regarding estimates or accounting policies may result in changes to Arena's guidance or previously reported results; risks related to unexpected or unfavorable new data; nonclinical and clinical data is voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Arena or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; topline data may not accurately reflect the complete results of a particular study or trial; satisfactory resolution of litigation or other disagreements with others; government and third-party payor actions, including relating to reimbursement and pricing; risks related to relying on collaborative arrangements; the entry into or modification or termination of collaborative arrangements; and Arena's and third parties' intellectual property rights. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the Securities and Exchange Commission (SEC), including but not limited to our Annual Report on Form 10-K for the year ended December 31, 2017, which was filed with the SEC on March 14, 2018, and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, which was filed with the SEC on May 9, 2018. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Corporate Contact:
Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer
klind@arenapharm.com
858.210.3636
Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com
646.627.8384
(Tables Follow)
Arena Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
Three months ended
Six months ended
June 30,
June 30,
2018
2017
2018
2017
(unaudited)
(unaudited)
Revenues
Collaboration and other revenue
$ 3,133
$ 1,898
$ 4,161
$ 3,558
Royalty revenue
861
—
1,588
—
Total revenues
3,994
1,898
5,749
3,558
Operating Costs & Expenses
Research & development
26,755
17,700
48,328
33,044
General & administrative
10,405
7,150
21,556
14,670
Total operating costs & expenses
37,160
24,850
69,884
47,714
Total interest & other income (expense), net
1,333
(811)
1,169
(2,158)
Loss from continuing operations
(31,833)
(23,763)
(62,966)
(46,314)
Income (loss) from discontinued operations
—
147
(830)
201
Net loss
(31,833)
(23,616)
(63,796)
(46,113)
Less net loss attributable to noncontrolling interest in consolidated variable interest entity
—
299
—
743
Net loss attributable to stockholders of Arena
$ (31,833)
$ (23,317)
$ (63,796)
$ (45,370)
Amounts attributable to stockholders of Arena:
Loss from continuing operations
$ (31,833)
$ (23,464)
$ (62,966)
$ (45,571)
Income (loss) from discontinued operations
—
147
(830)
201
$ (31,833)
$ (23,317)
$ (63,796)
$ (45,370)
Net income (loss) attributable to stockholders of Arena per share, basic and diluted:
Continuing operations
$ (0.65)
$ (0.77)
$ (1.41)
$ (1.66)
Discontinued operations
—
—
(0.02)
—
$ (0.65)
$ (0.77)
$ (1.43)
$ (1.66)
Shares used in calculating net loss attributable to stockholders of Arena per share, basic and diluted:
49,263
30,299
44,655
27,371
Arena Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheet Data
(In thousands)
(unaudited)
June 30, 2018
December 31, 2017
1
Assets
Cash & cash equivalents
$ 501,217
$ 158,837
Accounts receivable
2,334
2,357
Insurance recovery receivable
—
12,025
Prepaid expenses & other current assets
6,539
2,681
Total available for sale investments
91,190
112,482
Land, property & equipment, net
28,756
30,131
Other non-current assets
7,524
3,622
Assets of disposal group held for sale
—
17,140
Total assets
$ 637,560
$ 339,275
Liabilities & Stockholders' Equity
Accounts payable & accrued liabilities
$ 16,523
$ 15,622
Accrued litigation settlement
—
24,000
Total deferred revenues
1,415
2,177
Total lease financing obligations & other long-term liabilities
60,784
62,737
Liabilities of disposal group held for sale
—
27,595
Total stockholders' equity
558,838
207,144
Total liabilities & stockholders' equity
$ 637,560
$ 339,275
1 The Condensed Consolidated Balance Sheet Data has been derived from the audited financial statements as of that date.
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SOURCE Arena Pharmaceuticals, Inc.
What is going on here? This should be in the 50s by now.
Arena Pharmaceuticals Appoints Life Sciences Industry Veteran Kieran T. Gallahue to Board of Directors
SAN DIEGO, July 10, 2018 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA), a biopharmaceutical company focused on delivering novel, transformational medicines across multiple therapeutic areas, today announced the appointment of Kieran T. Gallahue as a non-executive director. Mr. Gallahue is a highly accomplished executive with over 25 years of leadership experience in publicly-traded life sciences companies.
"We are thrilled to have Kieran join our board of directors," said Tina Nova, Chairman of the Board of Directors of Arena. "His extraordinary leadership experience in the life sciences industry will be invaluable as we position the Company for long-term, sustainable growth. We look forward to leveraging Kieran's extensive expertise as we plan the path forward for our rapidly advancing, multi-product, Phase 3 ready pipeline."
Mr. Gallahue served as Chairman and Chief Executive Officer of CareFusion Corporation, a medical products company, from 2011 until its acquisition by Becton, Dickinson and Company in 2015 for $12.3 billion. He previously served as President, CEO and a director of ResMed, a medical device firm serving the sleep disordered breathing and respiratory markets, and also held a variety of senior-level positions at Nanogen, Inc., Instrumentation Laboratory, Procter & Gamble Co., and General Electric Co. Mr. Gallahue is currently a member of the boards of directors of medical device companies, Edwards Lifesciences Corporation and Intersect ENT. He previously served on the board of directors of Volcano Corporation, a developer of products for interventional cardiology and image guided therapy, from 2007 until its acquisition by Royal Philips in 2015. Mr. Gallahue also served on the Executive Committee of the Advanced Medical Technology Association, a trade association representing 80% of medical technology firms in the United States. He holds a bachelor's degree in Economics from Rutgers University and an MBA from Harvard Business School.
About Arena Pharmaceuticals
Arena Pharmaceuticals is focused on delivering novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena's proprietary pipeline includes multiple potentially first- or best-in-class programs with broad clinical utility. The most advanced investigational clinical programs are ralinepag (APD811), which will be commencing a Phase 3 program for pulmonary arterial hypertension (PAH), and etrasimod (APD334), which will be commencing a Phase 3 program for ulcerative colitis (UC) and a program in Crohn's Disease (CD), and which has potential utility for a broad range of immune and inflammatory conditions. Arena is also evaluating olorinab (APD371) in Phase 2 for the treatment of visceral pain associated with Crohn's disease, as well as other drug candidates in earlier research and development stages.
In addition, Arena has several collaborations including Everest Medicines Limited (ralinepag and etrasimod in Greater China and select Asian countries), Axovant Sciences GmbH (nelotanserin - Phase 2), Boehringer Ingelheim International GmbH (undisclosed target - preclinical), Outpost Medicine, LLC (undisclosed target – preclinical), and Eisai Co., Ltd. and Eisai Inc. (BELVIQ® - marketed product).
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These forward-looking statements may be accompanied by words such as "focused on," "will," "position the Company for," "look forward to," "plan," "path forward," "potentially," "potential," or words of similar meaning, or by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements include, without limitation, statements about Arena's potential for long-term, sustainable growth, programs (including their first- or best-in-class potential), focus and collaborations. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include that the timing and outcome of research, development and regulatory review is uncertain; clinical programs may not proceed at the time or in the manner expected or at all; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; and other risks related to developing and commercializing drugs. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the Securities and Exchange Commission (SEC), including but not limited to our Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, which was filed with the SEC on May 9, 2018. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Corporate Contact:
Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer
klind@arenapharm.com
858.210.3636
Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com
646.627.8384
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SOURCE Arena Pharmaceuticals, Inc.
It finally hit 50 today. Let's get over 100!
Arena Pharmaceuticals Announces Data Presentation for Ralinepag in Pulmonary Arterial Hypertension at the American Thoracic Society International Conference
SAN DIEGO, May 21, 2018 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that data from a post-hoc analysis of the 22-week Phase 2 clinical study for its investigative drug candidate ralinepag, a next-generation, oral, selective and potent prostacyclin receptor agonist in development for the treatment of pulmonary arterial hypertension (PAH), will be presented at the American Thoracic Society (ATS) International Conference on May 23. The meeting is taking place May 18-23 in San Diego, CA.
Dr. Hap Farber, Professor of Medicine and Director, Pulmonary Hypertension Center, Boston University/Boston Medical Center, will present an analysis of the correlation between ralinepag plasma levels and improvements in functional and hemodynamic parameters in patients with pulmonary arterial hypertension (PAH).
Arena previously announced topline Phase 2 results for ralinepag in PAH in which the primary efficacy analysis demonstrated a statistically significant absolute change from baseline in pulmonary vascular resistance compared to placebo. Ralinepag also demonstrated numerical improvement in 6-minute walk distance relative to placebo in patients on PAH specific background therapy. Adverse events observed in the study were consistent with other prostacyclin treatments for the management of PAH.
Presentation Details
Title: Ralinepag Plasma Levels Correlate With Improvements in Functional and Hemodynamic Parameters in Patients With Pulmonary Arterial Hypertension (PAH)
When: Wednesday, May 23, 1:30 PM PDT
About Ralinepag
Ralinepag (APD811) is an oral, next-generation, selective IP receptor agonist targeting the prostacyclin pathway and intended for the treatment of pulmonary arterial hypertension (PAH). Arena discovered and developed this drug candidate internally. Ralinepag's potency on vasodilation, inhibition of proliferation of vascular smooth muscle cells, and inhibition of platelet aggregation, combined with an extended half-life support its application as a potentially best-in-class agent for the treatment of PAH. Ralinepag is an investigational compound that is not approved for any use in any country.
About Arena Pharmaceuticals
Arena Pharmaceuticals is focused on delivering novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena's proprietary pipeline includes multiple potentially first- or best-in-class programs with broad clinical utility. The most advanced investigational clinical programs are ralinepag (APD811), which will be commencing a Phase 3 program for pulmonary arterial hypertension (PAH), and etrasimod (APD334), which will be commencing a Phase 3 program for ulcerative colitis (UC) and a program in Crohn's Disease (CD), and which has potential utility for a broad range of immune and inflammatory conditions. Arena is also evaluating olorinab (APD371) in Phase 2 for the treatment of visceral pain associated with Crohn's disease, as well as other drug candidates in earlier research and development stages.
In addition, Arena has several collaborations including Everest Medicines Limited (ralinepag and etrasimod in Greater China and select Asian countries), Axovant Sciences GmbH (nelotanserin - Phase 2), Boehringer Ingelheim International GmbH (undisclosed target - preclinical), Outpost Medicine, LLC (undisclosed target – preclinical), and Eisai Co., Ltd. and Eisai Inc. (BELVIQ® - marketed product).
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These forward-looking statements may be accompanied by words such as "will," "potential," "look forward to," "intended for," "potentially," "focused on," "designed to," or words of similar meaning, or by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements include, without limitation, statements about Arena's upcoming presentation at the ATS International Conference; ralinepag, including relating to its potential to be an effective PAH treatment or best-in-class, the Phase 3 clinical program in patients with PAH that is currently in development and potential findings from that study; and Arena's programs (including their first- or best-in-class potential), focus and collaborations. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include that clinical programs may not proceed at the time or in the manner expected or at all; enrolling patients in our ongoing and intended clinical trials is competitive and challenging; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; the timing and outcome of research, development and regulatory review is uncertain; topline data may not accurately reflect the complete results of a particular study or trial; nonclinical and clinical data are voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Arena or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; risks related to unexpected or unfavorable new data; and risks related to developing and commercializing drugs. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the Securities and Exchange Commission (SEC), including but not limited to our Annual Report on Form 10-K for the year ended December 31, 2017, which was filed with the SEC on March 14, 2018. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Corporate Contact:
Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer
klind@arenapharm.com
858.210.3636
Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com
646.627.8384
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SOURCE Arena Pharmaceuticals, Inc.
Arena Pharmaceuticals to Present at Upcoming Investor Conferences
SAN DIEGO, May 10, 2018 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that Amit D. Munshi, President and Chief Executive Officer, will present at the following investor conferences:
Bank of America Merrill Lynch Healthcare Conference in Las Vegas, NV on Thursday, May 17 at 11:35 a.m. PDT
UBS Global Healthcare Conference in New York, NY on Tuesday, May 22, 2018 at 9:30 a.m. EDT
A live audio webcast of the presentations will be available under the investor relations section of Arena's website at www.arenapharm.com. A replay of the presentation will be available for 30 days following the event.
About Arena Pharmaceuticals
Arena Pharmaceuticals is focused on delivering novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena's proprietary pipeline includes multiple potentially first- or best-in-class programs with broad clinical utility. The most advanced investigational clinical programs are ralinepag (APD811), which will be commencing a Phase 3 program for pulmonary arterial hypertension (PAH), and etrasimod (APD334), which will be commencing a Phase 3 program for ulcerative colitis (UC) and a program in Crohn's Disease (CD), and which has potential utility for a broad range of immune and inflammatory conditions. Arena is also evaluating olorinab (APD371) in Phase 2 for the treatment of visceral pain associated with Crohn's disease, as well as other drug candidates in earlier research and development stages.
In addition, Arena has several collaborations including Everest Medicines Limited (ralinepag and etrasimod in Greater China and select Asian countries), Axovant Sciences GmbH (nelotanserin - Phase 2), Boehringer Ingelheim International GmbH (undisclosed target - preclinical), Outpost Medicine, LLC (undisclosed target – preclinical), and Eisai Co., Ltd. and Eisai Inc. (BELVIQ® - marketed product).
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These forward-looking statements may be accompanied by words such as "upcoming," "will," "focused on," "potentially," "potential," or words of similar meaning, or by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements include statements about the upcoming presentations and about Arena's focus, programs and collaborations. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include that clinical programs may not proceed at the time or in the manner expected or at all, as well as those factors disclosed in Arena's filings with the Securities and Exchange Commission. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Corporate Contact:
Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer
klind@arenapharm.com
858.210.3636
Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com
646.627.8384
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SOURCE Arena Pharmaceuticals, Inc.
Arena Pharmaceuticals Provides Corporate Update and Reports First Quarter 2018 Financial Results
- Achieved positive Phase 2 results for etrasimod in ulcerative colitis in March; Phase 3 preparations for ulcerative colitis and a development plan for Crohn's disease underway
- Expect to initiate Phase 3 studies for ralinepag in pulmonary arterial hypertension in second half of 2018
SAN DIEGO, May 8, 2018 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today provided a corporate update and reported financial results for the first quarter ended March 31, 2018.
"After delivering positive Phase 2 data on our most advanced compounds, etrasimod and ralinepag, we are now focused on initiating multiple Phase 3 studies for both programs in addition to a range of Phase 2 studies to expand the utility of these compounds," said Amit D. Munshi, President and CEO of Arena. "In addition to executing on the trials for these potentially best-in-class candidates, we plan for additional program catalysts as we move through 2018. The next 12 to 18 months promise to be as exciting as the last."
Pipeline Update
Etrasimod – Oral, next generation, selective sphingosine-1-phosphate (S1P) receptor modulator intended for the potential treatment of multiple immune and inflammatory diseases
Ulcerative colitis (UC):
Crohn's disease (CD):
Primary biliary cholangitis (PBC):
Ralinepag – Oral, next generation, selective prostacyclin receptor agonist intended for the treatment of pulmonary arterial hypertension (PAH)
Expect to initiate two standalone, Phase 3 registrational studies, as well as additional differentiation studies, in H2 2018
Olorinab (formerly APD371) – Oral, peripherally restricted, full agonist of the cannabinoid 2 (CB2) receptor intended for the potential treatment of visceral pain, specifically pain associated with Crohn's disease
Plan to complete enrollment in Phase 2 trial in Q2 2018, with results expected in Q3 2018
Collaborations Update
In April 2018, Arena announced a licensing agreement with Outpost Medicine on a preclinical compound for the treatment of genitourinary disorders
Corporate Update
On March 31, 2018, Arena completed the sale of its manufacturing operations located in Zofingen, Switzerland to Siegfried
On March 26, 2018, Arena closed a public offering that raised aggregate net proceeds of $383.1 million through the issuance of approximately 9.8 million shares
Financial Update
First Quarter 2018 Financial Results
Revenues totaled $1.8 million, consisting of $1.0 million in collaboration revenue, and $0.7 million in royalty revenue
Research and development expenses totaled $21.6 million
General and administrative expenses totaled $11.2 million
Net loss attributable to stockholders of Arena was $32.0 million, or $0.80 per share
At March 31, 2018, Arena's cash, cash equivalents and investments balance was $629.1 million and approximately 49.2 million shares of Arena common stock were outstanding.
Conference Call & Webcast Information
Arena will host a conference call and live webcast with the investment community today, Tuesday, May 8, 2018, at 4:30 p.m. EDT to discuss the financial results and provide a corporate update.
When: Tuesday, May 8, 2018, at 4:30 p.m. EDT
Dial-in: (877) 643-7155 (United States) or (914) 495-8552 (International)
Conference ID: 7698222
Please join the conference call at least 10 minutes early to register. You can access the live webcast under the investor relations section of Arena's website at: www.arenapharm.com. A replay of the conference call will be archived under the investor relations section of Arena's website for 30 days shortly after the call.
About Arena Pharmaceuticals
Arena Pharmaceuticals is focused on delivering novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena's proprietary pipeline includes multiple potentially first- or best-in-class programs with broad clinical utility. The most advanced investigational clinical programs are ralinepag (APD811), which will be commencing a Phase 3 program for pulmonary arterial hypertension (PAH), and etrasimod (APD334), which will be commencing a Phase 3 program for ulcerative colitis (UC) and a program in Crohn's Disease (CD), and which has potential utility for a broad range of immune and inflammatory conditions. Arena is also evaluating olorinab (APD371) in Phase 2 for the treatment of visceral pain associated with Crohn's disease, as well as other drug candidates in earlier research and development stages.
In addition, Arena has several collaborations including Everest Medicines Limited (ralinepag and etrasimod in Greater China and select Asian countries), Axovant Sciences GmbH (nelotanserin - Phase 2), Boehringer Ingelheim International GmbH (undisclosed target - preclinical), Outpost Medicine, LLC (undisclosed target – preclinical), and Eisai Co., Ltd. and Eisai Inc. (BELVIQ® - marketed product).
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements may be identified by words such as "plan," "expect," "focused on," "potential," "promise," "intended," "intend," "planning," "expected," "will," and "potentially," and include, without limitation, statements about initiation, enrollment, results, data readouts and timing relating to ongoing and intended clinical trials; the potential of Arena's drug candidates; Arena's investment community conference call and webcast; and Arena's focus, goals, strategy, clinical programs, and collaborators. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the following: the risk that we may need additional funds to advance all of our programs, and you and others may not agree with the manner we allocate our resources; risks related to developing and commercializing drugs; enrolling patients in our ongoing and intended clinical trials is competitive and challenging; clinical trials and other studies may not proceed at the time or in the manner expected or at all; the timing and outcome of research, development and regulatory review is uncertain, and our drug candidates may not advance in development or be approved for marketing; risks and uncertainties relating to cash and revenues that may be generated from product sales or other sources, including the impact of competition; the risk that Arena's revenues are based in part on estimates, judgment and accounting policies, and incorrect estimates or disagreement regarding estimates or accounting policies may result in changes to Arena's guidance or previously reported results; risks related to unexpected or unfavorable new data; nonclinical and clinical data is voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Arena or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; topline data may not accurately reflect the complete results of a particular study or trial; satisfactory resolution of litigation or other disagreements with others; government and third-party payor actions, including relating to reimbursement and pricing; risks related to relying on collaborative arrangements; the entry into or modification or termination of collaborative arrangements; and Arena's and third parties' intellectual property rights. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the Securities and Exchange Commission (SEC), including but not limited to our Annual Report on Form 10-K for the year ended December 31, 2017, which was filed with the SEC on March 14, 2018. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Corporate Contact:
Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer
klind@arenapharm.com
858.210.3636
Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com
646.627.8384
(Tables Follow)
Arena Pharmaceuticals, Inc.Condensed Consolidated Statements of Operations(In thousands, except per share amounts)
Three months ended
March 31,
2018
2017
(unaudited)
(unaudited)
Revenues
Collaboration and other revenue
$ 1,028
$ 1,660
Royalty revenue
727
—
Total revenues
1,755
1,660
Operating Costs & Expenses
Research & development
21,573
15,344
General & administrative
11,151
7,520
Total operating costs & expenses
32,724
22,864
Total interest & other expense, net
(164)
(1,347)
Loss from continuing operations
(31,133)
(22,551)
Income (loss) from discontinued operations
(830)
54
Net loss
(31,963)
(22,497)
Less net loss attributable to noncontrolling interest in consolidated variable interest entity
—
444
Net loss attributable to stockholders of Arena
$ (31,963)
$ (22,053)
Amounts attributable to stockholders of Arena:
Loss from continuing operations
$ (31,133)
$ (22,107)
Income (loss) from discontinued operations
(830)
54
$ (31,963)
$ (22,053)
Net loss attributable to stockholders of Arena per share, basic and diluted:1
Continuing operations
$ (0.78)
$ (0.90)
Discontinued operations
(0.02)
—
$ (0.80)
$ (0.90)
Shares used in calculating net loss attributable to stockholders of Arena per share, basic and diluted1
39,996
24,482
1 Comparative period data adjusted to give effect to Arena's June 2017 1-for-10 reverse stock split.
Arena Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheet Data
(In thousands)
(unaudited)
March 31, 2018
December 31, 2017
1
Assets
Cash & cash equivalents
$ 516,141
$ 158,837
Accounts receivable
3,306
2,357
Insurance recovery receivable
12,025
12,025
Prepaid expenses & other current assets
5,409
2,681
Total available for sale investments
112,980
112,482
Land, property & equipment, net
29,507
30,131
Other non-current assets
6,100
3,622
Total assets of disposal group held for sale
—
17,140
Total assets
$ 685,468
$ 339,275
Liabilities & Equity
Accounts payable & accrued liabilities
$ 13,928
$ 15,622
Accrued litigation settlement
24,000
24,000
Total deferred revenues
1,615
2,177
Total lease financing obligations & other long-term liabilities
61,790
62,737
Total liabilities of disposal group held for sale
—
27,595
Total equity
584,135
207,144
Total liabilities & equity
$ 685,468
$ 339,275
1 The Condensed Consolidated Balance Sheet Data has been derived from the audited financial statements as of that date.
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SOURCE Arena Pharmaceuticals, Inc.
Arena Pharmaceuticals to Release First Quarter 2018 Financial Results and Provide Corporate Update on Tuesday, May 8
SAN DIEGO, May 2, 2018 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that the Company will release its first quarter 2018 financial results and provide a corporate update on Tuesday, May 8, 2018, after the close of the U.S. financial markets. The Company will host a conference call and live webcast with the investment community the same day at 4:30 p.m. EDT.
Conference Call & Webcast Information
When: May 8, 2018, 4:30 p.m. EDT
Dial-in: (877) 643-7155 (United States) or (914) 495-8552 (International)
Conference ID: 7698222
Please join the conference call at least 10 minutes early to register. You can access the live webcast under the investor relations section of Arena's website at: www.arenapharm.com. A replay of the conference call will be archived under the investor relations section of Arena's website for 30 days after the call.
About Arena Pharmaceuticals
Arena Pharmaceuticals is focused on developing novel, small molecule drugs with optimized receptor pharmacology and pharmacokinetics designed to deliver broad clinical utility across several therapeutic areas. Arena's proprietary pipeline includes potentially first- or best-in-class programs. The most advanced investigational clinical programs are ralinepag (APD811), which will be commencing a Phase 3 program for pulmonary arterial hypertension (PAH), and etrasimod (APD334), which will be commencing a Phase 3 program for ulcerative colitis (UC) and which has potential utility for a broad range of immune and inflammatory conditions. Arena is also evaluating APD371 in Phase 2 for the treatment of pain associated with Crohn's disease. In addition, Arena has collaborations with the following pharmaceutical companies: Everest Medicines Limited (ralinepag and etrasimod in Greater China and select Asian countries), Boehringer Ingelheim International GmbH (undisclosed target - preclinical), Outpost Medicine, LLC (undisclosed target – preclinical), Axovant Sciences GmbH (nelotanserin - Phase 2), and Eisai Co., Ltd. and Eisai Inc. (BELVIQ® - marketed product).
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about Arena's focus, and the potential of its programs and collaborations. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include those disclosed in Arena's filings with the Securities and Exchange Commission. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Corporate Contact:
Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer
klind@arenapharm.com
858.210.3636
Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com
646.627.8384
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SOURCE Arena Pharmaceuticals, Inc.
Arena Pharmaceuticals and Outpost Medicine Enter into Licensing Agreement for Undisclosed Novel Compound
- Arena's non-core, proprietary, preclinical compound provides strategic fit with Outpost Medicine's expertise in developing products for genitourinary disorders
SAN DIEGO and INDIANAPOLIS, May 1, 2018 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA), a biopharmaceutical company focused on developing novel, small molecule drugs across multiple therapeutic areas, and Outpost Medicine, a biopharmaceutical company focused on the development of new treatments of urologic and gastrointestinal disorders, today announced that they have entered into a licensing agreement to advance an undisclosed, preclinical compound with potential utility in treating genitourinary disorders. This compound, targeting an undisclosed G protein-coupled receptor (GPCR), was internally discovered by Arena.
"As we continue to focus on our potentially best-in-class pipeline, it is important that we seek opportunities to further develop and enhance the value of promising assets that do not fit into Arena's core therapeutic areas," said Amit D. Munshi, President and Chief Executive Officer of Arena. "This partnership allows us to leverage Outpost's scientific and disease specific expertise, with the goal of bringing this novel therapy to patients and is representative of the caliber of Arena's legacy discovery platform."
"This novel agent from Arena's historical GPCR platform is the perfect fit to expand our pipeline of potentially breakthrough urologic treatments. We are thrilled to partner with Arena on this innovative program and advance our goal of developing and commercializing medicines that truly advance patient care and quality of life," said Scott Byrd, President and Chief Executive Officer of Outpost.
Under the terms of the agreement, Arena has granted Outpost exclusive, worldwide rights to develop and commercialize the compound. In return, Arena will receive an upfront fee comprised of cash and equity totaling $3.0 million and is eligible to receive approximately $100 million in development and commercial milestone payments and up to low double-digit tiered royalties on annual net sales of the compound.
About Outpost Medicine
Outpost Medicine is a biopharmaceutical company focused on the development of novel therapeutics for the treatment of urologic and gastrointestinal disorders. Located in Indianapolis and London, Outpost is a private company launched in 2016 and has raised $64 million in Series A venture capital financing from Frazier Healthcare Partners, Adams Street Partners, Novo Holdings A/S, Vivo Capital and Takeda Ventures. For more information, visit Outpost's website at http://www.outpostmedicine.com.
About Arena Pharmaceuticals
Arena Pharmaceuticals is focused on developing novel, small molecule drugs with optimized receptor pharmacology and pharmacokinetics designed to deliver broad clinical utility across several therapeutic areas. Arena's proprietary pipeline includes potentially first- or best-in-class programs. The most advanced investigational clinical programs are ralinepag (APD811), which will be commencing a Phase 3 program for pulmonary arterial hypertension (PAH), and etrasimod (APD334), which will be commencing a Phase 3 program for ulcerative colitis (UC) and which has potential utility for a broad range of immune and inflammatory conditions. Arena is also evaluating APD371 in Phase 2 for the treatment of pain associated with Crohn's disease. In addition, Arena has collaborations with the following pharmaceutical companies: Everest Medicines Limited (ralinepag and etrasimod in Greater China and select Asian countries), Axovant Sciences GmbH (nelotanserin - Phase 2), Boehringer Ingelheim International GmbH (undisclosed target - preclinical), and Eisai Co., Ltd. and Eisai Inc. (BELVIQ® - marketed product).
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These forward-looking statements may be accompanied by words such as "will," "potential," "look forward to," "intended for," "potentially," "focused on," "designed to," or words of similar meaning, or by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements include, without limitation, statements about Arena's license agreement with Outpost, including its focus and potential payments to Arena, Outpost's expertise and goals, the potential of Arena's legacy platform, and Arena's programs (including their first- or best-in-class potential and expected clinical development), focus and other collaborations. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include: risks relating to working with collaborators, including Arena will have limited control over the development and, if applicable, commercialization of the licensed compound, and the potential for disagreements; clinical programs may not proceed at the time or in the manner expected or at all; enrolling patients in our ongoing and intended clinical trials is competitive and challenging; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; the timing and outcome of research, development and regulatory review is uncertain; topline data may not accurately reflect the complete results of a particular study or trial; nonclinical and clinical data are voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Arena or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; risks related to unexpected or unfavorable new data; and risks related to developing and commercializing drugs. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the Securities and Exchange Commission (SEC), including but not limited to our Annual Report on Form 10-K for the year ended December 31, 2017. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Corporate Contact:
Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer
klind@arenapharm.com
858.210.3636
Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com
646.627.8384
Outpost Medicine Media Contact:
Theresa Owens
Targeted Communications
Theresa@targetedco.com
317.983.4476
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SOURCE Arena Pharmaceuticals, Inc.
Arna was featured on CNBC with Cramer's lightning round. Check it out.
A really nice couple days. Gotta love the new CEO and how well spoken he is and the vision he portrays to potential investors and takeover companies. Let's see what comes next out of all the potential opportunities
Huge day today so far. Go ARNA.
Arena Pharmaceuticals Announces Phase 2 Data Presentation for Ralinepag in Pulmonary Arterial Hypertension at the International Society for Heart and Lung Transplantation Annual Meeting
SAN DIEGO, April 12, 2018 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that data from a post-hoc analysis of the 22-week Phase 2 clinical study for its investigative drug candidate ralinepag, a next-generation, oral, selective and potent prostacyclin receptor agonist in development for the treatment of pulmonary arterial hypertension (PAH), will be presented at the International Society for Heart and Lung Transplantation (ISHLT) 2018 Annual Meeting on April 14. The meeting is taking place April 11-14 in Nice, France.
Dr. Raymond Benza, Cardiovascular Institute, Allegheny General Hospital, Pittsburgh, will present the results of an analysis assessing the impact of ralinepag treatment on mortality risk, as measured by three risk scoring methodologies (REVEAL, FPHN and COMPERA), in patients on PAH specific background therapy. Registry risk scores are used to identify patients at the highest risk for mortality and assess the impact of treatments on moving patients into a low-risk category.
"Patients receiving ralinepag experienced improvements in their mortality risk category using three risk scoring methodologies developed and utilized globally," said Dr. Benza. "These positive data further highlight the potential of ralinepag as an effective treatment of PAH, and I look forward to determining the impact of ralinepag on clinical outcomes in the Phase 3 clinical program."
Arena previously announced topline Phase 2 results for ralinepag in PAH in which the primary efficacy analysis demonstrated a statistically significant absolute change from baseline in pulmonary vascular resistance compared to placebo. Ralinepag also demonstrated numerical improvement in 6-minute walk distance relative to placebo. Adverse events observed in the study were consistent with other prostacyclin treatments for the management of PAH.
Presentation Details
Title: Ralinepag, An Oral, Selective, Prostacyclin (IP) Receptor Agonist Consistently Improved Mortality Risk Scores Derived From PAH Registries Across Three Regions: Phase 2 Study Analysis
When: Saturday, April 14, 1:30 PM - 1:45 PM
About Ralinepag
Ralinepag (APD811) is an oral, next-generation, selective IP receptor agonist targeting the prostacyclin pathway and intended for the treatment of pulmonary arterial hypertension (PAH). Arena discovered and developed this drug candidate internally. Ralinepag's potency on vasodilation, inhibition of proliferation of vascular smooth muscle cells, and inhibition of platelet aggregation, combined with an extended half-life support its application as a potentially best-in-class agent for the treatment of PAH. Ralinepag is an investigational compound that is not approved for any use in any country.
About Arena Pharmaceuticals
Arena Pharmaceuticals is focused on developing novel, small molecule drugs with optimized receptor pharmacology and pharmacokinetics designed to deliver broad clinical utility across several therapeutic areas. Arena's proprietary pipeline includes potentially first- or best-in-class programs. The most advanced investigational clinical programs are ralinepag (APD811), which will be commencing a Phase 3 program for pulmonary arterial hypertension (PAH), and etrasimod (APD334), which will be commencing a Phase 3 program for ulcerative colitis (UC) and which has potential utility for a broad range of immune and inflammatory conditions. Arena is also evaluating APD371 in Phase 2 for the treatment of pain associated with Crohn's disease. In addition, Arena has collaborations with the following pharmaceutical companies: Everest Medicines Limited (ralinepag and etrasimod in Greater China and select Asian countries), Axovant Sciences GmbH (nelotanserin - Phase 2), Boehringer Ingelheim International GmbH (undisclosed target - preclinical), and Eisai Co., Ltd. and Eisai Inc. (BELVIQ® - marketed product).
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These forward-looking statements may be accompanied by words such as "will," "potential," "look forward to," "intended for," "potentially," "focused on," "designed to," or words of similar meaning, or by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements include, without limitation, statements about Arena's upcoming presentation at the ISHLT Annual Meeting; ralinepag, including relating to its potential to be an effective PAH treatment or best-in-class, the Phase 3 clinical program in patients with PAH that is currently in development and potential findings from that study; and Arena's programs (including their first- or best-in-class potential), focus and collaborations. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include that clinical programs may not proceed at the time or in the manner expected or at all; enrolling patients in our ongoing and intended clinical trials is competitive and challenging; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; the timing and outcome of research, development and regulatory review is uncertain; topline data may not accurately reflect the complete results of a particular study or trial; nonclinical and clinical data are voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Arena or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; risks related to unexpected or unfavorable new data; and risks related to developing and commercializing drugs. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the Securities and Exchange Commission (SEC), including but not limited to our Annual Report on Form 10-K for the year ended December 31, 2017, which was filed with the SEC on March 14, 2018. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Corporate Contact:
Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer
klind@arenapharm.com
858.210.3636
Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com
646.627.8384
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SOURCE Arena Pharmaceuticals, Inc.
Brought my average further down on yesterday’s losses... sitting on $43 a share. Can’t wait till this touch $50+
ARNA- an Arena Pharmaceuticals bull case opinion.
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Do you suppose that the huge share price drop in advance of the positive trial news was engineered to make $41.50 seem like a good deal?
Arena Pharmaceuticals Announces Pricing of Public Offering of Common Stock
SAN DIEGO, March 21, 2018 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced the pricing of an underwritten public offering of 8,500,000 shares of its common stock at a price to the public of $41.50 per share. All of the shares are being sold by Arena. The gross proceeds from the offering are expected to be approximately $352.8 million, before deducting the underwriting discounts and commissions and offering expenses. The offering is expected to close on March 26, 2018, subject to customary closing conditions. In addition, Arena has granted the underwriters a 30-day option to purchase up to 1,275,000 additional shares of its common stock at the public offering price, less the underwriting discounts and commissions.
Arena anticipates using the net proceeds from the offering for the clinical and preclinical development of drug candidates, including its planned Phase 3 programs for etrasimod for the treatment of ulcerative colitis and ralinepag for the treatment of pulmonary arterial hypertension, for general corporate purposes, including working capital and costs associated with manufacturing services, and for capital expenditures.
Citigroup, Leerink Partners, Cantor Fitzgerald, Credit Suisse and RBC Capital Markets are acting as joint book-running managers for the offering. Guggenheim Securities and JMP Securities are acting as co-managers for the offering.
The shares of common stock described above are being offered by Arena pursuant to a shelf registration statement filed by Arena with the Securities and Exchange Commission (SEC) that became automatically effective on July 11, 2017. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC's website located at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; or from Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at (800) 808-7525 ext. 6132, or by email at syndicate@leerink.com; or from Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 6th Floor, New York, NY 10022, or by email at prospectus@cantor.com; or from Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, One Madison Avenue, New York, NY 10010, or by telephone at (800) 221-1037, or by email at newyork.prospectus@credit-suisse.com; or from RBC Capital Markets LLC, Attention: Equity Syndicate, 200 Vesey Street, 8th Floor, New York, NY 10281-8098, or by telephone at (877) 822-4089, or by email at equityprospectus@rbccm.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About Arena Pharmaceuticals
We are a biopharmaceutical company focused on developing novel, small molecule drugs with optimized receptor pharmacology designed to deliver clinical utility across multiple therapeutic areas. Our proprietary, internally-developed pipeline includes multiple potentially first- or best-in-class programs. Our three most advanced clinical programs are: ralinepag (APD811), which we are currently preparing for a Phase 3 program for pulmonary arterial hypertension; etrasimod (APD334), for which we are planning a Phase 3 program for ulcerative colitis and are continuing to study for other immune and inflammatory conditions; and APD371 for visceral pain conditions and which is being studied in a Phase 2 trial for treatment of pain associated with Crohn's disease. In addition, we have collaborations with the following pharmaceutical companies: Everest Medicines Limited (ralinepag and etrasimod in Greater China and select countries in Asia), Axovant Sciences GmbH (nelotanserin - Phase 2), Boehringer Ingelheim International GmbH (undisclosed target - preclinical), and Eisai Co., Ltd. and Eisai Inc. (BELVIQ®/BELVIQ XR® - marketed products).
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These statements may be identified by introductory words such as "may," "expects," "plan," "believe," "will," "achieve," "anticipate," "would," "should," "subject to" or words of similar meaning, or by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements include statements regarding Arena's expectations with respect to the completion, timing and size of the public offering, and Arena's anticipated use of the net proceeds from the offering. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the public offering; and those factors disclosed in Arena's filings with the SEC, including our Form 10-K for the year ended December 31, 2017. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Corporate Contact:
Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer
klind@arenapharm.com
858.210.3636
Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com
646.627.8384
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SOURCE Arena Pharmaceuticals, Inc.
Arena Pharmaceuticals (NASDAQ:ARNA) is 2.2% lower postmarket after pricing its upsized 8.5M-share public offering at $41.50/share.
• Arena's selling all share, and gross proceeds come to $352.8M. Underwriters have a 30-day option to buy up to 1.275M additional shares at the offering price.
• Net proceeds will go to clinical and preclinical development of drug candidates, including planned phase 3 programs for etrasimod (for the treatment of ulcerative colitis) and ralinepag (for the treatment of pulmonary arterial hypertension), as well as general purposes.
• Joint book-runners are Citigroup, Leerink Partners, Cantor Fitzgerald, Credit Suisse and RBC Capital Markets.
• Shares had risen 10.7% during the regular session today to close at $44; they're quoted at $43.05 after hours.
MM’s are here... ARNA will be a soon buyout... easy $100 per share
Damn this CEO is taking investors on a roller coaster ride... $42 before earnings -$30 after earnings-$42 after positive phase 2 now it will be back to $32...I guess
Secondary offering lol.
Me too.. I was thinking to buy at $30 was just waiting to see a reversal pattern but the stock got halted in AH and the reversal was so good.. but I managed to get some $36 in AH yesterday. I believe this has a potential to go to $60 within a month. It can be a buyout candidate soon too. So hold your horses.. I can see it at $100 plus before phase 3 if a buyout happens.
How are we to interpret the huge drop leading up to the good news? False rumors? Manipulation? I did manage to buy a few more shares at $35 (though I was kicking myself when it continued down to $30).
Arena Pharmaceuticals (ARNA -1.97%) surged over 50% in after-hours trading after it reported positive results from a Phase 2 study of its Etrasimod in patients with Ulcerative Colitis.
UPDATE: Arena Pharma (ARNA) PT Raised to Street High $79 at JMP Securities, 'Phase 2 Etrasimod Results are Outstanding'
Arena Pharmaceuticals Reports Positive Phase 2 Results from the OASIS Trial for Etrasimod in Patients with Ulcerative Colitis
- OASIS trial met primary and all secondary endpoints with statistical significance for patients receiving 2 mg dose of etrasimod for 12 weeks
- The 2 mg etrasimod group achieved statistically significant improvement in clinical remission
- Safety results support potential best-in-class profile
- Arena intends to initiate a Phase 3 program in ulcerative colitis
- Investor conference call and webcast today at 4:30 p.m. EDT (1:30 p.m. PDT)
SAN DIEGO, March 19, 2018 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA), today announced positive topline Phase 2 results from the OASIS trial for etrasimod, an investigational, once-daily, orally administered, selective sphingosine 1-phosphate (S1P) receptor modulator in development for the treatment of ulcerative colitis (UC). Patients receiving the 2 mg dose of etrasimod achieved statistically significant improvements versus placebo in the primary, all secondary, and clinical remission endpoints.
Relative to placebo, there was a statistically significant (p = 0.009) 0.99 point improvement in a 3-component (stool frequency, rectal bleeding and findings on endoscopy) Mayo Clinic Score (ranging from 0 to 9) with etrasimod 2 mg at week 12. In the 1 mg group, there was a 0.43 point improvement in 3-component Mayo Clinic Score at week 12 relative to placebo, which was not statistically significant (p = 0.146). Significantly more patients in the etrasimod 2 mg group achieved endoscopic improvement compared with placebo (41.8% vs. 17.8%, p = 0.003).
The proportion of patients achieving clinical remission, defined by the 3-component Mayo Clinic Score, was 33.0% in the etrasimod 2 mg group compared to 8.1% for the placebo group (p < 0.001). Remission as defined by the 4-component Total Mayo Clinic Score was 24.5% and 6.0% for etrasimod 2 mg and placebo, respectively (p = 0.004).
Etrasimod was well tolerated and there were fewer patients with serious adverse events (SAEs) compared to placebo (0% in 2 mg, 5.8% in 1 mg and 11.1% in placebo). Impact on heart rate and atrioventricular (AV) conduction was low throughout the study with no discontinuations from study related to bradycardia or AV block. There were no increases in liver function tests compared to placebo and no reports of macular edema or pulmonary function test abnormalities. The Company plans to present full study results at future medical congresses.
"The results of this Phase 2 trial are impressive and demonstrate statistically significant efficacy of orally administered etrasimod, including clinically meaningful improvement in remission, as well as endoscopic improvement in what has been historically referred to as mucosal healing," said William Sandborn, M.D., Professor of Medicine and Chief, Division of Gastroenterology and Director, University of California San Diego Inflammatory Bowel Disease Center. "Despite recent advances in treatment options, there remains a significant unmet need for new oral therapies for ulcerative colitis. I look forward to etrasimod advancing into a Phase 3 program."
Preston Klassen, M.D., M.H.S., Executive Vice President, Research and Development and Chief Medical Officer of Arena Pharmaceuticals, said, "We believe these data support proceeding to a Phase 3 program in ulcerative colitis and continuing efforts to understand the broad potential utility of etrasimod in other immune and inflammatory diseases with significant unmet needs. Along with the positive Phase 2 results for ralinepag reported last year, this important milestone for the Company further amplifies our conviction in Arena's internally discovered and developed compounds and their potential to be best-in-class."
Conference Call & Webcast Information
Arena will host a conference call and live webcast with the investment community today, March 19, 2018, at 4:30 p.m. EDT to discuss the study results and provide a corporate update.
When: March 19, 2018, 4:30 p.m. EDT
Dial-in: (877) 643-7155 (United States) or (914) 495-8552 (International)
Conference ID: 7299327
Please join the conference call at least 10 minutes early to register. You can access the live webcast under the investor relations section of Arena's website at: www.arenapharm.com. A replay of the conference call will be archived under the investor relations section of Arena's website for 30 days shortly after the call.
About OASIS
OASIS was a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to assess safety and efficacy of two orally administered doses (1 mg and 2 mg) of etrasimod in patients with ulcerative colitis (UC) across 71 sites in 16 countries. The OASIS trial randomized 156 patients, with moderate to severe UC (3-component Mayo Clinic Score of 4-9 with an endoscopic subscore ≥ 2 and a rectal bleeding score ≥ 1). The pre-specified statistical analysis plan applied one-sided testing, in which conventional statistical significance is achieved at p-values < 0.025.
About Etrasimod
Etrasimod (APD334), is an oral, once-daily, next generation, selective sphingosine 1-phosphate (S1P) receptor modulator, discovered by Arena, designed to provide systemic and local cell modulation by targeting S1P receptor subtypes 1, 4 and 5, while avoiding subtypes 2 and 3. Etrasimod is believed to exhibit potentially best-in-class pharmacokinetics and pharmacodynamics with rapid onset of action and rapid recovery of T lymphocytes. Selective binding with S1P receptor subtype 1 is believed to inhibit a specific subset of activated lymphocytes from migrating to sites of inflammation. The result is a reduction of circulating T and B lymphocytes that leads to anti-inflammatory activity while immune surveillance is maintained. The receptor subtypes 4 and 5 exhibit similar activity on additional proliferating immune cell types. Optimized pharmacology and pharmacokinetics may allow improved clinical utility across a broad range of immune and inflammatory conditions.
Etrasimod is an investigational compound not approved for any use in any country.
About Arena Pharmaceuticals
Arena Pharmaceuticals is focused on developing novel, small molecule drugs with optimized receptor pharmacology and pharmacokinetics designed to deliver broad clinical utility across several therapeutic areas. Arena's proprietary pipeline includes potentially first- or best-in-class programs. The most advanced investigational clinical programs are ralinepag (APD811), which is anticipated to commence a Phase 3 program for pulmonary arterial hypertension (PAH), and etrasimod (APD334), for which the Company intends to commence a Phase 3 program for ulcerative colitis (UC) and which the Company believes has potential utility for a broad range of immune and inflammatory conditions. Arena is also evaluating APD371 in Phase 2 for the treatment of pain associated with Crohn's disease. In addition, Arena has collaborations with the following pharmaceutical companies: Everest Medicines Limited (ralinepag and etrasimod in Greater China and select Asian countries), Axovant Sciences GmbH (nelotanserin - Phase 2), Boehringer Ingelheim International GmbH (undisclosed target - preclinical), and Eisai Co., Ltd. and Eisai Inc. (BELVIQ® - marketed product).
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These forward-looking statements may be identified by introductory words such as "potential," "plans," "look forward to," "promise," "will," "can," "designed to," "believed to," "may," "focused on," "being evaluated for," "expected," "intended," "potentially," "goal," "believe," or words of similar meaning, or by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements include, without limitation, statements regarding the importance of etrasimod's Phase 2 data; etrasimod's potential to be a best-in-class treatment in UC and to have broad utility in other immune and inflammatory diseases with significant unmet needs; plans for etrasimod's Phase 3 development; publication plans; and Arena's focus, goals, strategy, clinical programs and collaborations. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include the following: the topline data is based on preliminary analysis of key data, and such data or analysis may change following a more comprehensive review of the data, and such topline data may not accurately reflect the complete results of a particular study or trial; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; nonclinical and clinical data are voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Arena or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; the timing and outcome of research, development and regulatory review is uncertain; we expect to need additional funds to advance all of our programs, and you and others may not agree with the manner we allocate our resources; our drug candidates may not advance in development or be approved for marketing; clinical trials and other studies may not proceed at the time or in the manner expected or at all; enrolling patients in our ongoing and intended clinical trials is competitive and challenging; unexpected or unfavorable new data; risks related to developing and commercializing drugs; risks related to relying on partners and other third parties; Arena's and third parties' intellectual property rights; and satisfactory resolution of litigation or other disagreements with others. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the Securities and Exchange Commission (SEC), including but not limited to our Annual Report on Form 10-K for the year ended December 31, 2017, which was filed with the SEC on March 14, 2018. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Corporate Contact:
Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer
klind@arenapharm.com
858.210.3636
Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com
646.627.8384
https://mma.prnewswire.com/media/436843/Arena_Pharmaceuticals_Logo.jpg
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SOURCE Arena Pharmaceuticals, Inc.
I have heard many people saying it can be a buyout at these level..
Wow!! Looking like we have a phase 3 candidate. Anyone know if Arena is a buyout candidate or building a brand name of its own?
Yes.. just wait tomorrow new price targets will be coming out.. previous price target by credit sussie was $53. I can see the price target going up to $80. I am buying more tomorrow morning.
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ARENA PHARMACEUTICALS, Inc. (ARNA)
http://www.arenapharm.com/
http://finance.yahoo.com/q/h?s=ARNA
http://www.secform4.com/insider-trading/1080709.htm
Arena Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, focuses on the discovery, development, and commercialization of oral drugs for cardiovascular, central nervous system, inflammatory, and metabolic diseases. It is developing a pipeline of compounds targeting orphan G protein-coupled receptors using its drug discovery technologies, including constitutively activated receptor technology and Melanophore technology. The company?s drug candidate, lorcaserin hydrochloride, is in Phase 3 clinical trial program for the treatment of obesity. Its other lead development programs include APD125, a 5-HT2a serotonin receptor inverse agonist, which is in Phase 2 clinical trail for the treatment of insomnia; APD791, an anti-thrombotic drug candidate, which is in preclinical development stage for the treatment of arterial thromboembolic diseases, such as acute coronary syndrome. The company has collaboration agreements with Ortho-McNeil Pharmaceutical, Inc. for developing APD668, an orally administered drug candidate, which is under clinical development for the treatment of type 2 diabetes and other disorders; and with Merck & Co., Inc. for the development of MK-0354 for atherosclerosis and related disorders. Arena Pharmaceuticals was incorporated in 1997 and is based in San Diego, California.
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