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Latest insider market buys plus institutional purchases:
Apple Hospitality REIT Chairman Jirka Rysavy Buys $755,976.06 in $APLE
First Trust Advisors LP Increases Stock Position in Apple Hospitality REIT Inc (NYSE:APLE)
https://sundanceherald.com/2019/09/09/first-trust-advisors-lp-boosts-holdings-in-apple-hospitality-reit-inc-nyseaple.html
IPG CHAIRMAN-CEO MICHAEL ROTH ON THE POTENTIAL FOR ECONOMIC DOWNTURN
'Everyone knows it’s coming ... we got out of certain countries where we weren’t making any money'
By Lindsay Rittenhouse. Published on September 09, 2019.
https://adage.com/article/qaa/ipg-chairman-ceo-michael-roth-potential-economic-downturn/2195176
$GT CFRA RAISES OPINION ON THE GOODYEAR TIRE & RUBBER COMPANY TO BUY FROM HOLD
September 6, 2019 (CFRA)
We maintain our 12-month target price of $15 based on 6.8x our '20 EPS estimate, a late-cycle discount to the stock's five-year average forward P/E of 8.7x. Our adjusted EPS estimates remain $1.60 for '19 and $2.20 for '20. The upgrade comes after a period of significant underperformance for GT, both on an absolute basis and relative to its closest comp, The Cooper Tire & Rubber Company (CTB 24 ***). GT shares are -40.2% YTD versus -25.2% for CTB and +19.0% for the S&P 500, following 2018 performance of -35.4% for GT, -7.3% for CTB and -6.2% for the S&P. While GT's 1H 2019 results were hideous, with adjusted EPS plummeting 60.7%, we see significantly easier comps in 2H 2019, as lower oil prices should help support margins (two-thirds of its raw materials costs are petroleum-based). We also see demand for higher-margin replacement tires (73% of GT's total tire sales last year) remaining steady and find the stock's current 5.2% dividend yield attractive.
$PFE Pfizer shares remain attractively valued, says Cowen Cowen analyst Steve Scalia updated his Pfizer (PFE) model following Q2 results, the closing of the Glaxo (GSK) Consumer joint venture, and the announcement that its Upjohn business would be divested and combined with Mylan (MYL). The analyst lowered his estimates to reflect what is left at the company and despite his revision feels the shares remain attractively valued. Scalia reiterated his Outperform rating and $48 price target on Pfizer shares.
MullenLowe Selected as Creative Agency Partner for Humana
https://www.businesswire.com/news/home/20190903005872/en/
Opinion: Five dividend stocks to buy because insiders love them
Published: Aug 27, 2019
https://www.marketwatch.com/story/five-dividend-stocks-to-buy-because-insiders-love-them-2019-08-27
Dow Stock Is Cheap for Too Many Reasons
DOW cannot blame all of its problems on external factors
By Will Healy, InvestorPlace Contributor Aug 22, 2019, 3:06 pm
https://investorplace.com/2019/08/dow-stock-cheap-many-reasons/
Just more business and income bottom line:
Navy Federal Credit Union Selects MullenLowe and Mediahub as New Creative and Media Agency Partners
Wed August 21, 2019 7:10 PM|Business Wire|About: IPG
Financial Services Company Specializing in Supporting Military Service Members, Veterans, and Their Families Unites with Agency Steeped in Working with Mission-Driven Brands
BOSTON--(BUSINESS WIRE)-- Navy Federal Credit Union, the world’s largest credit union, with a mission of supporting military service members, veterans, and their families, has selected MullenLowe and Mediahub as its new creative and media agency partners. MullenLowe and Mediahub are sibling agencies which specialize in working with mission-driven brands like Navy Federal to drive outstanding business performance with breakthrough creativity and media innovation. The selection of the new agency partners follows a rigorous competitive review process which began in March of this year and was completed in early August.
Navy Federal will work with MullenLowe and Mediahub on national and regional brand strategy, advertising creative content, and media planning and buying to drive new membership in the credit union and expanded engagement and support for current Navy Federal members. Agency personnel from MullenLowe and Mediahub’s Boston and New York offices were involved in the review process and will be working directly with Navy Federal’s marketing and business unit management team based in Vienna, Virginia.
MullenLowe and Mediahub have extensive knowledge of and familiarity with the military service community based on a nearly 20-year relationship with the United States Department of Defense assisting with educational communications related to military service. Additionally, the agency has deep experience in financial services within the core Navy Federal team and across its integrated practice groups. In selecting MullenLowe and Mediahub, Navy Federal has aligned with a many-time Advertising Age A-List Agency and the Media Agency of the Year for the past two years according to Advertising Age and Adweek, respectively.
“In a true sign of partnership, the MullenLowe and Mediahub team delved deep into understanding Navy Federal’s mission and our commitment to our members,” said Pam Piligian, senior vice president of marketing and communications at Navy Federal. “They got to know us and see our culture in action. They helped us imagine an evolution of our creative message and inspired us with new ways of thinking about media as a platform for member service.”
“Navy Federal was founded with the purpose of improving the financial lives of those who serve, and that mission remains core to their business today,” said Kelly Fredrickson, president of MullenLowe Boston and New York. “We’ve been inspired since the early days of the review by the strength of Navy Federal’s culture and by the unique opportunity that we will have as their partner to serve their membership and broader community. Financial services is a dynamic and rapidly changing category, and we are proud to partner with a company so focused on helping its members achieve their life and financial goals.”
“The Navy Federal team exhibited strong curiosity about the power of media science to transform the way they communicate with and support their members,” said Sean Corcoran, U.S. president of Mediahub. “They have a keen understanding of their core consumer and an intelligent vision for how to evolve their marketing and carefully grow the overall membership. We will have the opportunity to explore truly innovative methods of utilizing media to inform and support this tight-knit community.”
About Navy Federal Credit Union: Established in 1933 with only seven members, Navy Federal now has the distinct honor of serving over eight million members globally and is the world’s largest credit union. As a member-owned and not-for-profit organization, Navy Federal always puts the financial needs of its members first. Membership is open to all Department of Defense and Coast Guard Active Duty, veterans, civilian and contractor personnel, and their families. Dedicated to its mission of service, Navy Federal employs a workforce of over 18,000 and has a global network of 336 branches. For more information about Navy Federal Credit Union, visit navyfederal.org.
About MullenLowe and Mediahub: MullenLowe and Mediahub are key components of the global MullenLowe Group agency network, a wholly owned subsidiary of the Interpublic Group of Companies (IPG). MullenLowe and Mediahub provide a hyperbundled suite of world-class capabilities in brand strategy, creative development, media planning and buying, marketing analytics, customer-relationship management, digital marketing and transformation, and public relations. The agency specializes in working with several mission-driven challenger brands including JetBlue Airways, Whole Foods Market, and Netflix.
https://cts.businesswire.com/ct/CT?id=bwnews&sty=20190821005782r1&sid=acqr7&distro=nx&lang=en
View source version on businesswire.com: https://www.businesswire.com/news/home/20190821005782/en/
David Swaebe
(617) 226-9932
david.swaebe@mullenlowe.com
Source: Navy Federal Credit Union
Copyright Business Wire 2019 4,992
Smart, right along with you on the add side. Been oversold the past 3 days on the RSI so we`ll see if this plays by the 3 day rule.
Thank you @MrCheap and added more today to go along with this continued orchestrated short attach.
Grabbed my starter position 1000 shares yesterday & today. Maybe a little late but definitely early for the next leg up.
IPG / Interpublic Group of Companies, Inc. (The) - Institutional Ownership - Buyers
Major holders that have opened new positions in IPG / Interpublic Group of Companies, Inc. (The) include South Texas Money Management Ltd, W. E. Donoghue & Co., Llc, Shellback Capital, LP, Weiss Multi-Strategy Advisers LLC, Millennium Management Llc, Perella Weinberg Partners Capital Management LP, Corient Capital Partners, LLC, Alethea Capital Management, LLC, Krasney Financial LLC, BBT Capital Management, LLC, Syntal Capital Partners, LLC, Dean Capital Management, Sawtooth Asset Management, Inc., Segall Bryant & Hamill, Llc, Delta Investment Management, Llc, Patton Albertson & Miller, LLC, Financial Advisors Network, Inc., Covenant Multifamily Offices, LLC, Centiva Capital, Lp, and Mitsubishi UFJ Securities Holdings Co., Ltd..
https://fintel.io/so/us/ipg
What Does Confidential Treatment Order Mean? A confidential treatment order (CTO) is an order that provides confidential treatment for certain documents and information that a company would otherwise have to file with the Securities and Exchange Commission (SEC).
https://www.investopedia.com/terms/c/confidential-treatment-order.asp#targetText=What%20Does%20Confidential%20Treatment%20Order,and%20Exchange%20Commission%20(SEC).
Vicinium Shows Encouraging CR Rate in High-Risk NMIBC Trial, Moving Towards BLA Submission
Vicinium has demonstrated positive 12-month complete response (CR) rate findings in the VISTA trial of patients with high-risk patients with non–muscle-invasive bladder cancer (NMIBC) who were unresponsive to bacillus Calmette-Guérin (BCG) treatment, according to updated preliminary findings from the phase III clinical trial.1
Across 2 of the 3 patient cohorts, patients with carcinoma in situ who had received prior BCG therapy demonstrated a CR rate of 28% (95% CI, 19%-39%) at 6 months and 17% (95% CI, 10%-26%) at 12 months. CR rate is one of the primary endpoints of the VISTA trial.
Sesen Bio, the developer of Vicinim, announced in a press release that these findings will serve as the basis on a biologics license application (BLA) submission to the FDA in the fourth quarter of 2019 for a potential accelerated approval.
“After 2 very positive meetings with the FDA in the second quarter, we are now focused on initiating the BLA submission for Vicinium in the fourth quarter under an accelerated approval pathway with rolling review,” said Thomas Cannell, DVM, president and chief executive officer of Sesen Bio, in the press release. “We believe this regulatory pathway and our strong 12-month phase III data could potentially expedite patient access to Vicinium, which is particularly important in light of the ongoing BCG shortage.”
Vicinium is a protein fusion drug consisting of an epithelial cell adhesion molecule (EpCAM)-specific antibody fragment fused to Pseudomonas Exotoxin A, a potent inhibitor of protein synthesis.
VISTA is an open-label, multicenter, single-arm phase III trial exploring the efficacy and tolerability of the monotherapy in a high-risk population of patients with NMIBC who were unresponsive to BCG treatment (NCT02449239).
Patients in the trial were adults with carcinoma in situ and/or high-grade (Ta and T1) papillary disease who were unresponsive to prior treatment with BCG with or without interferon. Participants must have completed at least 2 courses of full-dose BCG, with at least 5 doses in the first course and 2 doses in the second course, and experienced disease recurrence within 30 weeks from last BCG treatment for those with papillary NMIBC, or within 50 weeks for those with CIS.2
The outpatient VISTA trial consists of a screening period, a 12-week induction phase, and a maintenance phase of up to 21 cycles of treatment, for a total of 104 weeks of treatment. The 133 patients were also divided into 1 of 3 cohorts: those with carcinoma in situ with or without papillary disease that was refractory or the patient had recurred within 6 months of adequate BCG treatment, those with carcinoma in situ with or without papillary disease that recurred between 6 and 11 months of BCG treatment, and patients with papillary disease only that recurred within 6 months of BCG treatment.
Vicinium at 30 mg in 50 mL of saline was instilled into the bladder 2 hours on a schedule of 2 times per week for 6 weeks in the induction phase, followed by weekly for 6 weeks followed by every 2 weeks for up to 2 years as the maintenance phase.
The primary endpoints of the trial are CR rate and the duration of response (DOR) in the first cohort. Secondary endpoints include time to disease recurrence in the third cohort as well as time to cystectomy, progression-free survival, event-free survival, and overall survival across all 3 cohorts.
According to earlier findings from the phase III trial, more than 95% of screened NMIBC samples expressed EpCAM. Additionally, the treatment was well tolerated, with adverse events (AEs) noted in 46% of patients. The most common AEs were dysuria (12%), urinary tract infection or pollakiuria (10%), and hematuria (7%). Three treatment-related serious AEs were observed, including renal failure with cholestatic hepatitis in one patient and acute kidney injury in another patient that recovered.2
Updated preliminary findings showed that in the first cohort of 82 evaluable patients who completed the induction phase, the CR rate was 39% at 3 months, 26% at 6 months, and 17% at 12 months. In the second cohort of 7 evaluable patients who completed the induction phase, the CR rate was 57% at 3 months, 57% at 6 months, and 14% at 12 months.1
In the first cohort, the median DOR was 273 days (95% CI, 122-not available [NA]) among 86 patients. An ad-hoc analysis of patients from both cohorts 1 and 2 (n = 93) showed that among patients who achieved a CR at 3 months, 52% had a CR for 12 months or more.
The median time to disease recurrence in patients in the third cohort (n = 40) was 402 days (95% CI, 170-NA).
Across the 3 cohorts, more than 75% of patients treated with Vicinium were estimated to remain cystectomy-free at 3 years, 90% were estimated to remain progression-free for 2 years or more, 29% were estimated to remain event free at 1 year, and 96% were estimated to have an overall survival of 2 years or more.
Updated safety findings showed that 95% of all AEs were grade 1 or 2. Serious AEs were observed in 14% of patients. Four patients discontinued treatment due to an AE.
An Oncologic Drugs Advisory Committee meeting is expected to occur after the BLA is submitted to review the risk-benefit profile of Vicinium.
The FDA had also granted a fast track designation to Vicinium last August for the treatment of patients with BCG-unresponsive, high-grade NMIBC.
References
Sesen Bio Reports Positive, Preliminary Data Update from Phase 3 VISTA Trial for High-Risk Non-Muscle Invasive Bladder Cancer [press release]. Cambridge, MA: Sesen Bio; August 8, 2019. https://bit.ly/2OM9LEB. Accessed August 9, 2019.
Dickstein R, Wu N, Cowan B, et al. Phase 3 study of Vicinium in BCG-unresponsive non-muscle invasive bladder cancer: initial results. J Urol. 2018;199(4S; abstr LBA27):e1167. doi: 10.1016/j.juro.2018.03.099.
https://www.targetedonc.com/news/vicinium-shows-encouraging-cr-rate-in-highrisk-nmibc-trial-moving-towards-bla-submission
In a report released today, Swayampakula Ramakanth from H.C. Wainwright reiterated a Buy rating on Sesen Bio Inc (SESN), with a price target of $2.25. The company’s shares closed on Friday at $1.19.
Ramakanth wrote:
“We have updated our financial model for the reported financial results. For 2019, we now project no revenues and a net loss of $0.83 per share. The company reported cash and cash equivalents of $65M at the end of 2Q19, which we believe is sufficient to fund operations through 2020. Due to the dilution from the 20.4M shares and 20.4M warrants from the June public offering, we are lowering our 12-month price target to $2.25, down from $3.00 previously.”
According to TipRanks.com, Ramakanth has 0 stars on 0-5 star ranking scale with an average return of -11.9% and a 28.2% success rate. Ramakanth covers the Healthcare sector, focusing on stocks such as Zomedica Pharmaceuticals Corp, IntelGenx Technologies, and Gritstone Oncology Inc.
Sesen Bio Inc has an analyst consensus of Moderate Buy, with a price target consensus of $2.25.
https://www.smarteranalyst.com/new-blurbs/sesen-bio-inc-sesn-receives-a-buy-from-h-c-wainwright/?mod=mw_quote_news
Dr. Abedin on PI3K Inhibitors in CLL
Sameem Abedin, MD
Published: Monday, Aug 12, 2019
https://www.onclive.com/onclive-tv/dr-abedin-on-pi3k-inhibitors-in-cll
Sameem Abedin, MD, assistant professor, Medical College of Wisconsin, discusses the use of PI3K inhibitors in the treatment of patients with chronic lymphocytic leukemia (CLL).
There are two approved PI3K inhibitors in CLL: duvelisib (Copiktra) and idelalisib (Zydelig). In 2018, the FDA approved duvelisib for the treatment of patients with relapsed/refractory CLL based on results from the phase III DUO study. In the trial, patients with relapsed/refractory CLL who had received ≥2 prior lines of therapy experienced a 60% reduction in the risk of disease progression or death versus ofatumumab (Arzerra).
In 2014, idelalisib was approved for use in combination with rituximab (Rituxan) in the relapsed/refractory setting based on data from the phase III Study 116 trial (NCT01539512). The trial was stopped early due to the dramatic improvement in progression-free survival (PFS) with the combination. At 24 weeks, the PFS rate of PFS was 93% in the combination arm and 46% in the rituximab-alone arm. The agents have slightly different mechanisms of action, and duvelisib has more immune properties, says Abedin.
In terms of administration, duvelisib is given as monotherapy, whereas idelalisib is given in combination with rituximab. For patients, the ease of taking a pill may be preferable to the combination, according to Abedin.
Ian W. Flinn, MD, PhD, on CLL/SLL: Effect of Dose Modifications on Response to Duvelisib
https://www.jnccn360.org/cll/videos/effect-of-dose-modifications-on-response-to-duvelisib/
Reply1
Company Reports $3.0 Million in Net Product Revenues from COPIKTRA(R); Raises Product Revenue Guidance for 2019
Cash, Cash Equivalents and Short-Term Investments of $187.3 Million as of June 30, 2019
Verastem Oncology Signs an Exclusive License Agreement with Sanofi for the Development and Commercialization of COPIKTRA® (duvelisib) in Russia and CIS, Turkey, the Middle East and Africa
Thu July 25, 2019 4:05 PM|Business Wire|About: VSTM
Verastem Oncology to Receive an Upfront Payment of $5 Million USD; Then Eligible to Receive Up To $42 Million USD in Development and Sales Milestones and Double-Digit Percentage Royalties
Sanofi Obtains Rights to Develop and Commercialize COPIKTRA in the Licensed Territories
BOSTON--(BUSINESS WIRE)-- Verastem, Inc. (VSTM) operating as Verastem Oncology, (or “the Company”), today announced their entry into an exclusive licensing agreement with Sanofi to develop and commercialize Verastem Oncology’s COPIKTRA® (duvelisib), an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, for the treatment of all oncology indications in Russia and CIS, Turkey, the Middle East and Africa.
Under the terms of the agreement, Verastem Oncology shall receive an upfront payment of $5 million USD. Verastem Oncology is also eligible to receive up to an additional $42 million USD in development and sales milestone payments, plus double-digit percentage royalties based on future net sales of COPIKTRA in the licensed territories. Sanofi will receive exclusive rights to develop and commercialize COPIKTRA, and hold the marketing authorization and product license for COPIKTRA, in the licensed territories. Sanofi will also have the right to collaborate with Verastem Oncology on certain global development and clinical trial activities.
“Sanofi brings world-class capabilities in developing and commercializing products, making them an ideal partner to bring COPIKTRA to patients in these territories,” said Dan Paterson, President and Chief Operating Officer of Verastem Oncology. “Establishing this third partnership outside the U.S. validates the global potential of COPIKTRA and underscores our commitment to bring COPIKTRA to patients worldwide.”
David Khougazian, Head of Sanofi Genzyme, China & Emerging Markets, commented, “As a specialty care leader, we welcome partnerships that have the potential to bring value for patients and caregivers. This agreement adds to our pipeline an oncology medicine with an innovative mechanism of action and a significant potential of new hope for the patients suffering from those types of blood malignancies with high unmet medical need. Partnering with Verastem Oncology for the development and commercialization of COPIKTRA is consistent with our goals to deliver enhanced patient care and to expand our presence in oncology in Emerging Markets.”
COPIKTRA was approved in September 2018 by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. In addition, COPIKTRA has been granted accelerated approval by the FDA for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Accelerated approval in FL was based on overall response rate and continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. COPIKTRA includes a Boxed Warning for fatal and serious toxicities including infections, diarrhea or colitis, cutaneous reactions and pneumonitis. See full Prescribing Information for complete Boxed Warning and other important safety information.
About Verastem Oncology
Verastem Oncology (Nasdaq: VSTM) is a commercial biopharmaceutical company committed to the development and commercialization of medicines to improve the lives of patients diagnosed with cancer. We are driven by the strength, tenacity and courage of those battling cancer – single-minded in our resolve to deliver new therapies that not only keep cancer at bay, but improve the lives of patients diagnosed with cancer. Because for us, it’s personal.
Our first FDA approved product is now available for the treatment of patients with certain types of indolent non-Hodgkin’s lymphoma (iNHL). Our pipeline comprises product candidates that seek to treat cancer by modulating the local tumor microenvironment. For more information, please visit www.verastem.com.
Verastem Oncology Forward Looking Statements
This press release includes forward-looking statements about Verastem Oncology’s strategy, future plans and prospects, including statements regarding the development and activity of Verastem Oncology’s lead product COPIKTRA, and Verastem Oncology’s PI3K program generally, its commercialization of COPIKTRA, the potential commercial success of COPIKTRA, the anticipated adoption of COPIKTRA by patients and physicians, the structure of its planned and pending clinical trials and the timeline and indications for clinical development, regulatory submissions and commercialization activities. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement.
Applicable risks and uncertainties include the risks and uncertainties, among other things, regarding: the commercial success of COPIKTRA in the United States; physician and patient adoption of COPIKTRA, including those related to the safety and efficacy of COPIKTRA; the uncertainties inherent in research and development of COPIKTRA, such as negative or unexpected results of clinical trials; whether and when any applications for COPIKTRA may be filed with regulatory authorities in any other jurisdictions; whether and when regulatory authorities in any other jurisdictions may approve any such other applications that may be filed for COPIKTRA, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted and, if approved, whether COPIKTRA will be commercially successful in such jurisdictions; our ability to obtain, maintain and enforce patent and other intellectual property protection for COPIKTRA and our other product candidates; the scope, timing, and outcome of any legal proceedings; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of COPIKTRA; the fact that regulatory authorities in the U.S. or other jurisdictions, if approved, could withdraw approval; whether preclinical testing of our product candidates and preliminary or interim data from clinical trials will be predictive of the results or success of ongoing or later clinical trials; that the timing, scope and rate of reimbursement for our product candidates is uncertain; that third-party payors (including government agencies) may not reimburse for COPIKTRA; that there may be competitive developments affecting our product candidates; that data may not be available when expected; that enrollment of clinical trials may take longer than expected; that COPIKTRA or our other product candidates will cause unexpected safety events, experience manufacturing or supply interruptions or failures, or result in unmanageable safety profiles as compared to their levels of efficacy; that COPIKTRA will be ineffective at treating patients with lymphoid malignancies; that we will be unable to successfully initiate or complete the clinical development and eventual commercialization of our product candidates; that the development and commercialization of our product candidates will take longer or cost more than planned; that we may not have sufficient cash to fund our contemplated operations; that we, Sanofi, CSPC Pharmaceutical Group, Yakult Honsha Co., Ltd. or Infinity Pharmaceuticals, Inc. will fail to fully perform under the duvelisib license agreements; that we may be unable to make additional draws under our debt facility or obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity, debt financing or otherwise; that we will not pursue or submit regulatory filings for our product candidates, including for duvelisib in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) or indolent non-Hodgkin lymphoma (iNHL) in other jurisdictions; and that our product candidates will not receive regulatory approval, become commercially successful products, or result in new treatment options being offered to patients.
Other risks and uncertainties include those identified under the heading "Risk Factors" in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2019, as filed with the Securities and Exchange Commission (SEC) on May 9, 2019, its Annual Report on Form 10-K for the year ended December 31, 2018 as filed with the SEC on March 12, 2019 and in any subsequent filings with the SEC. The forward-looking statements contained in this press release reflect Verastem Oncology’s views as of the date hereof, and the Company does not assume and specifically disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
https://cts.businesswire.com/ct/CT?id=bwnews&sty=20190725005671r1&sid=acqr7&distro=nx&lang=en
View source version on businesswire.com: https://www.businesswire.com/news/home/20190725005671/en/
Investors:
John Doyle
Vice President, Investor Relations & Finance
+1 781-292-4279
jdoyle@verastem.com
Media:
Lisa Buffington
Corporate Communications
+1 781-292-4205
lbuffington@verastem.com
Source: Verastem, Inc.
Copyright Business Wire 2019
https://seekingalpha.com/pr/17583528-verastem-oncology-signs-exclusive-license-agreement-sanofi-development-commercialization
Now they can concentrate on finding some positive results with FDA guidelines set and letting go unneeded personal. $5.00 stock again soon.
"The in vitro assays we presented to the FDA reflect Zafgen's deep understanding of the significant difference of ZGN-1061 on endothelial cell biology as compared to our prior compound and we believe represent a truly sophisticated and optimized approach to evaluate important safety information about ZGN-1061," said Priya Singhal, M.D., M.P.H, Head of Research and Development. "We are working to rapidly implement the in vivo animal study, which aims to establish the relevance of the in vitro mechanism and safety margins. We appreciate the FDA's thorough feedback and continuing collaboration throughout this process."
Given the current status and expected timelines of Zafgen's development programs, the Company has implemented plans to reduce its operating expenses and prioritize key resources, with an immediate corporate restructuring as well as other strategies to preserve resources. This restructuring includes a workforce reduction of approximately 25%, in addition to other attrition in 2019. With these changes, Zafgen now expects its projected cash runway to last greater than two years, given its current operating plan.
"Since our constructive Type A meeting with the FDA earlier this year, we've been focused on gaining clarity on the path forward, reaching agreement on the in vivo study design and protocol, and preparing for strong initiation and execution of the study," said Jeffrey Hatfield, Chief Executive Officer. "As we move ahead with ZGN-1061 having accomplished these goals, we have also taken steps to ensure the effective use of capital as we look to the future. This includes the difficult but prudent decision to restructure at this time. We are deeply grateful for the entire team's dedication and many contributions."
Biotechs' Second-Half Battle
https://seekingalpha.com/article/4276463-biotechs-second-half-battle
Biotechs' Second-Half Battle
https://seekingalpha.com/article/4276463-biotechs-second-half-battle
Biotechs' Second-Half Battle
https://seekingalpha.com/article/4276463-biotechs-second-half-battle
Sesen Bio: Upside From Potential Vicinium Approval
https://seekingalpha.com/article/4275842-sesen-bio-upside-potential-vicinium-approval
$ZFGN Zafgen, Inc. (NASDAQ:ZFGN) has 92 institutional investors and shareholders that have filed 13D/G or 13F forms with the Securities Exchange Commission (SEC). These institutions hold a total of 28,642,877 shares. Largest shareholders include Atlas Venture Advisors, Inc., Great Point Partners Llc, Armistice Capital, Llc, Farallon Capital Management Llc, Vanguard Group Inc, FMR LLC / Fidelity, AWM Investment Company, Inc., 683 Capital Management, LLC, Mangrove Partners, and BlackRock Inc..
Zafgen, Inc. (NASDAQ:ZFGN) ownership structure shows current positions in the company by institutions and funds, as well as latest changes in position size. Major shareholders can include individual investors, mutual funds, hedge funds, or institutions. The Schedule 13D indicates that the investor holds more than 5% of the company and intends to actively pursue a change in business strategy.
https://fintel.io/so/us/zfgn
Exactly (-;
$BLRX A few days old but still worth a listen or you can have the transcript emailed to you.
JMP Securities Life Sciences Conference 2019
June 19, 2019
The St. Regis New York
2 East 55th Street
New York, NY 10022
Presentation
Click here for webcast
https://ir.biolinerx.com/events/event-details/jmp-securities-life-sciences-conference-2019
I gave up on options on this especially after the latest news, just buying and trading shares on the open market makes it more interesting while holding a large core position.
LOL, I'm liking the bowering stats today.
https://iborrowdesk.com/report/VSTM
Remember each new script averages about $250,000 for 12 months on COPIKTRA™
https://investor.verastem.com/news-releases/news-release-details/verastem-oncology-presents-copiktratm-duvelisib-data-peripheral
Shares of many biotech companies have rallied following the announcement of the Pfizer PFE – Array BioPharma ARRY deal. Announced earlier this week, the deal has an enterprise value of approximately $11.4 billion. The deal is likely to strengthen Pfizer’s oncology portfolio as Array BioPharma is focused on developing targeted small molecule drugs for treating cancer and other high-burden diseases. Its first commercial therapy, Braftovi plus Mektovi, approved as a treatment for BRAF-mutant melanoma, was approved July last year and has shown encouraging uptake. Cancer has become the area of focus of several pharmaceutical companies due to unmet needs and lucrative market opportunities.
https://finance.yahoo.com/news/cancer-gene-therapy-biotechs-focus-152003662.html