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BioXcel Therapeutics to Ring Nasdaq Stock Market Closing Bell Today
NEW HAVEN, Conn., Feb. 21, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics, additional members of the management team, and other BioXcel team members will ring the closing bell of the Nasdaq Stock Market today, Tuesday, February 21, 2023.
"At BioXcel Therapeutics, we are building a disruptive biopharmaceutical business model to successfully drive accelerated AI-enabled drug development and commercialization," said Dr. Mehta. "Today we are celebrating a year of significant accomplishments that include FDA approval and launch of our first product, IGALMI(TM) sublingual film, for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. In addition, we look forward to market-expansion opportunities for our overall neuropsychiatric program, with two pivotal study readouts planned for BXCL501 in the first half of 2023. Recently, we also reported positive Phase 2 data for our lead immuno-oncology program, BXCL701, in combination with KEYTRUDA(R), which is in development for the treatment of a rare, aggressive form of prostate cancer. As BioXcel advances its lead drug candidates in two therapeutic areas, we appreciate Nasdaq's recognition of our progress through today's closing bell ceremony."
The ceremony will take place at the Nasdaq MarketSite, 4 Times Square, New York, beginning at 3:45 PM ET. It can be viewed at https://livestream.com/accounts/27896496/events/10752444.
ADMA Biologics receives FDA approval for its eighth plasma collection center, located in Hammond, LA
This plasma collection facility commenced operations and initiated source plasma collection in the second quarter of 2022. With the FDA approval announced today, this facility is now licensed to collect, and introduce into interstate commerce, human source plasma for further manufacturing in the U.S.
BTAI is chugging right along.
ADMA Biologics Announces Closing of $69 Million Public Offering Including Full Exercise of Underwriters Option to Purchase Additional Shares
ADMA Biologics Announces Closing of $69 Million Public Offering Including Full Exercise of Underwriters' Option to Purchase Additional Shares
RAMSEY, N.J. and BOCA RATON, Fla., Dec. 09, 2022 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq:ADMA) ("ADMA" or the "Company"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced the closing of its previously announced underwritten public offering of 20,979,020 shares of its common stock at a public offering price of $2.86 per share, in addition to the exercise in full of the underwriters' option to purchase an additional 3,146,853 shares of common stock. The gross proceeds from the exercise of the overallotment option were $9 million, bringing the total gross proceeds to ADMA from the offering to $69 million, before deducting underwriting discounts and commissions and other estimated offering expenses.
ADMA intends to use the net proceeds from this offering to accelerate commercialization and production activities, complete plasma center buildout and obtain FDA approvals, to conclude post FDA marketing approval research and development projects, and for working capital, capital expenditures and for general corporate purposes.
Raymond James & Associates, Inc., Cantor Fitzgerald & Co. and Mizuho Securities USA LLC acted as joint book-running managers of the offering.
The offering of the securities described above was made by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-256643) previously filed with the Securities and Exchange Commission ("SEC") and declared effective by the SEC on August 3, 2021. The final prospectus supplement, including the accompanying prospectus, relating to the offering was filed with the SEC on December 7, 2022 and is available on the SEC's website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, or by telephone at (800) 248-8863, or e-mail at prospectus@raymondjames.com, or from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 4th Floor, New York, New York 10022 or by email at prospectus@cantor.com, or from Mizuho Securities USA LLC, Attention: Equity Capital Markets, 1271 Avenue of the Americas, 3rd Floor, New York, NY 10020, by email at US-ECM@us.mizuho-sc.com, or by telephone at (212) 205-7600.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such
First Patients Dosed in SERENITY III Phase 3 Trial for Acute Treatment of Agitation in Adults with Bipolar I or II Disorder or Schizophrenia
BioXcel Therapeutics Announces First Patients Dosed in SERENITY III Phase 3 Trial for Acute Treatment of Agitation in Adults with Bipolar I or II Disorder or Schizophrenia
SERENITY III will evaluate the efficacy and safety of BXCL501 for at-home use
Top-line pivotal data expected in 1H 2023
Estimated 23 million annual agitation episodes in the home-setting would more than double current market opportunity for BXCL501 in the U.S. (1) (-4)
NEW HAVEN, Conn., Nov. 30, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that the first 13 patients have been dosed in Part 1 of the pivotal Phase 3 SERENITY III trial investigating at-home use of BXCL501 (dexmedetomidine) sublingual film, the Company's proprietary, orally dissolving film, for agitation associated with bipolar I or II disorder or schizophrenia.
"Evaluating BXCL501 for at-home use is an exciting and important milestone that potentially expands the market opportunity for the treatment of agitation and drives the growth of our neuroscience franchise," said Robert Risinger, M.D., Chief Medical Officer, Neuroscience of BioXcel Therapeutics. "We anticipate top-line data from SERENITY III as well as our TRANQUILITY II trial for Alzheimer's-related agitation in the first half of 2023. These two near-term pivotal data readouts further reinforce the potential of BXCL501 to address the unmet medical needs of millions of patients."
The treatment of agitation represents a significant market opportunity. There are approximately 39 million reported agitation episodes that occur in the U.S. each year related to bipolar disorders and schizophrenia.(1) (-4) 23 million of these episodes occur outside of the institutional setting, potentially more than doubling the current market opportunity for BXCL501.
SERENITY III is a two-part, double-blinded, placebo-controlled pivotal study designed to evaluate BXCL501 60mcg dose for at-home use. This strategic trial design follows a Type B meeting with the U.S. Food and Drug Administration and observed dose-dependent responses in a prior Phase 1/2b study assessing a range of doses. The first part of the study is similar to SERENITY I and II and designed to assess the efficacy and safety of a 60mcg dose in acutely agitated patients with bipolar disorder or schizophrenia in a monitored setting. The primary efficacy endpoint is the change from baseline in Positive and Negative Syndrome Scale-Excitatory Component (PEC) total score at two hours after dosing compared to placebo. In Part 1, approximately 200 patients will be enrolled at up to approximately 20 clinical sites in the U.S. The second part of the study is designed to assess the safety of 60mcg dose compared to placebo when self-administered at home. SERENITY III will utilize many of the same investigators and clinical sites as SERENITY I and II.
I was hoping for $5. more a share but a win is a win haha
Kala Pharmaceuticals Announces EYSUVIS Now Covered by OptumRx
Thu, June 3, 2021
-- EYSUVIS Added to OptumRx Commercial Formularies Effective May 21, 2021 --
-- Expands Total Commercial Coverage for EYSUVIS to More Than 88 Million Lives --
Kala Pharmaceuticals, Inc., (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that OptumRx, one of the largest pharmacy benefit managers (PBM) in the United States, has added EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% as a covered brand on its commercial formularies, effective May 21, 2021.
"We are pleased to announce the addition of EYSUVIS to OptumRx’s commercial formularies, which represents a significant milestone towards our goal of ensuring broad market access," said Todd Bazemore, Chief Operating Officer of Kala Pharmaceuticals. "More than 88 million people with commercial health insurance now have access to EYSUVIS. We anticipate this figure will continue to grow from our ongoing efforts with Commercial and Medicare Part D health plans, as we work towards our ultimate goal of delivering broad payer coverage for EYSUVIS to the millions of people in the United States who suffer from dry eye disease."
EYSUVIS was approved by the U.S. Food and Drug Administration (FDA) in October 2020 as the first and only prescription therapy indicated specifically for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. Kala commenced the promotional launch of EYSUVIS in the United States in January 2021. EYSUVIS is available through both national and regional U.S. pharmaceutical distribution centers, as well as local retail pharmacies or home delivery.
Myovant Sciences and Pfizer Receive FDA Approval for MYFEMBREE
the first once-daily treatment for heavy menstrual bleeding associated with uterine fibroids
In the Phase 3 LIBERTY 1 and LIBERTY 2 studies, MYFEMBREE demonstrated 72.1% and 71.2% response rates in menstrual blood loss (MBL) at Week 24, with MBL reductions of 82.0% and 84.3% from baseline. Myovant and Pfizer will jointly commercialize MYFEMBREE, with product availability expected in June.
Myovant, Pfizer See Positive Data From Uterine Fibroids Therapy Study
By Chris Wack
Myovant Sciences Ltd. and Pfizer Inc. said Wednesday they saw positive data from the Phase 3 study of relugolix combination therapy in women with uterine fibroids.
The companies said this study was designed to assess the safety and efficacy of continued treatment with relugolix combination therapy for up to two years.
The study met its primary endpoint, with 78.4% of women who continued on relugolix combination therapy achieving the sustained responder rate of menstrual blood loss of less than 80 mL through week 76, compared with 15.1% of women who discontinued treatment and initiated placebo at week 52, the companies said.
All three key secondary endpoints were also achieved, including sustained responder rate at two years, time to relapse of heavy menstrual bleeding, and amenorrhea rate.
Through two years, 69.8% of women who continued on relugolix combination therapy remained responders, the companies said. And 88.3% of women who discontinued treatment at Week 52 relapsed with heavy menstrual bleeding, with a median time of return to heavy menstrual bleeding of 5.9 weeks.
The incidence of adverse events over one additional year of treatment was consistent with those observed in prior studies, with no new safety signals observed. The most commonly reported adverse event in at least 10% of women treated with relugolix combination therapy was nasopharyngitis.
Relugolix combination tablet is under review by the U.S. Food and Drug Administration for the treatment of women with uterine fibroids, with a decision expected by the June 1, 2021, target action date.
Kala Pharmaceuticals Announces Preferred Position for EYSUVIS(TM) on Cigna
-- Commercial formulary coverage effective May 15, 2021 --
WATERTOWN, Mass.--(BUSINESS WIRE)--March 16, 2021--
Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that Cigna has added EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% as a preferred brand on its commercial formulary, effective May 15, 2021.
"We are pleased to announce the addition of EYSUVIS to Cigna's preferred formulary, reflecting a significant expansion of our commercial coverage and important progress toward our goal of securing broad patient access, " said Todd Bazemore, Chief Operating Officer of Kala Pharmaceuticals. "We look forward to continuing to engage with other commercial and Medicare Part D health plans as we execute on our strategy to optimize coverage, with the goal of delivering EYSUVIS as the preferred prescription therapy for the millions of people in the United States who suffer from dry eye disease flares."
EYSUVIS was approved in October 2020 as the first and only prescription therapy indicated specifically for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. EYSUVIS became commercially available in the United States in January 2021 and is available through both national and regional U.S. pharmaceutical distribution centers, as well as local retail pharmacies or home delivery.
Kala Pharmaceuticals Announces EYSUVIS(TM) Now Covered by Express Scripts
Express Scripts coverage effective February 5, 2021
WATERTOWN, Mass.--(BUSINESS WIRE)--February 16, 2021--
Kala Pharmaceuticals, Inc., (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that Express Scripts, one of the leading pharmacy benefit managers (PBM) in the United States, has added EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% to its National Preferred, Basic and High Performance Formularies, effective February 5, 2021. EYSUVIS is the first and only prescription therapy approved specifically for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease.
"The addition of EYSUVIS to Express Scripts' formulary is a significant milestone towards our goal of optimizing coverage and ensuring patients and eye care professionals have access to a rapid-acting, short-term treatment for the signs and symptoms of dry eye disease, including dry eye flares," said Todd Bazemore, Chief Operating Officer of Kala Pharmaceuticals. "We are pleased that Express Scripts is now covering EYSUVIS, and we expect to further expand formulary coverage in the coming weeks and months so more patients and eye care professionals can benefit from EYSUVIS."
EYSUVIS was approved in October 2020 and became commercially available in the United States in January 2021. It is available through both national and regional U.S. pharmaceutical distribution centers, as well as local retail pharmacies or home delivery.
Agenus Announces New Responses for AGEN1181
Agenus Announces New Responses for AGEN1181
-- 6 total confirmed objective clinical responses in colon, ovarian, and
endometrial cancers
-- No complement-mediated toxicities reported
LEXINGTON, Mass., Feb. 09, 2021 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, today announced additional confirmed objective clinical responses from its Phase 1/2 trial of AGEN1181, its next-generation anti-CTLA-4, as monotherapy and in combination with Agenus' anti-PD-1 balstilimab.
"These are very exciting results which demonstrate the potential of AGEN1181 as an efficacious next-generation CTLA-4 antibody. AGEN1181 is showing activity in difficult-to-treat tumors without the neuroendocrine or significant liver toxicities commonly observed with the currently-approved CTLA-4 antibody ipilimumab," said Dr. Steven O'Day, Chief Medical Officer at Agenus. "The responses seen in patients with ovarian and MSS colorectal cancer are particularly encouraging given the generally low activity seen with immunotherapy in these indications."
The Phase 1 dose escalation trial has had no reports of complement-mediated toxicities. These are severe toxicities associated with first-generation CTLA-4 antibodies. The trial has also defined the optimal combination dose for AGEN1181 +/- balstilimab.
Agenus also presented on the first-ever report of intratumoral Treg depletion with a CTLA-4 antibody in clinical trials at SITC 2020.
The summary of responses with AGEN1181 alone or in combination with balstilimab are as follows:(1)
-- CR in PD-L1(-) MSS endometrial cancer patient (1181 monotherapy)
-- CR by PET in PD-L1(-) MSS endometrial cancer patient (1181 + bal)
-- PR in PD-L1(-) refractory ovarian cancer patient (1181 + bal)
-- PR in colorectal cancer patient (1181 + bal)
-- PR in MSS colorectal cancer patient (1181 + bal) -- new confirmed
response
-- PR in ovarian cancer patient (1181 + bal) -- new confirmed response
AGEN1181 alone and in combination with balstilimab has expanded dosing into colorectal cancer. Phase 2 trials in additional cancer indications are scheduled to commence shortly.
Everything moving along nicely here.
Myovant Sciences, Pfizer Report Positive Results From Relugolix Trial
Myovant Sciences and Pfizer Inc. reported positive results from a Phase 3 long-term extension study of the investigational once-daily relugolix combination.
The companies said the therapy in women with endometriosis showed clinically meaningful reductions in dysmenorrhea and nonmenstrual pelvic pain over one year with minimal and stable bone mineral density loss. The data were consistent with the efficacy and safety profile observed through 24 weeks in the previous Phase 3 studies.
These results will be included in the new drug application to the U.S. Food and Drug Administration for relugolix combination tablet for the treatment of women with endometriosis, which the companies intend to submit in the first half of 2021, they said.
In the long-term extension study, 84.8% and 73.3% of women receiving relugolix combination therapy over one year achieved clinically meaningful pain reductions in dysmenorrhea and nonmenstrual pelvic pain, respectively. Bone mineral density remained stable through Week 52 in women treated with relugolix combination therapy after minimal, nonclinically meaningful bone loss through Week 24, the companies said.
In December, Myovant and Pfizer entered into a collaboration for the development and commercialization of relugolix in oncology and women's health in the U.S. and Canada. Myovant and Pfizer will jointly develop and commercialize Orgovyx relugolix in advanced prostate cancer and, if approved, relugolix combination tablet in uterine fibroids and endometriosis, they said.
Can you tell us all how this is a scam?
Kala anticipates that its cash, cash equivalents and short-term investments as of December 31, 2020, along with anticipated sales of INVELTYS, will enable it to fund its operations into at least the fourth quarter of 2022. Kala expects revenue anticipated to be generated from sales of EYSUVIS will provide additional cash runway.
Kala Pharmaceuticals announced the launch of EYSUVIS 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease
7:03 AM ET 1/7/21 | Briefing.com
EYSUVIS is now available in national and regional U.S. pharmaceutical distribution centers. Patients with a prescription can access EYSUVIS through their local retail pharmacies or through home delivery.
Kala has completed the hiring and onboarding of its expanded ophthalmology sales force, which now consists of 91 sales professionals calling on eyecare professionals, including ophthalmologists and optometrists. The Company plans to expand its sales force to approximately 125 sales representatives in 2021, pending the status of the COVID-19 pandemic.
I think it will hit it.
Myovant Sciences, Pfizer to Develop, Commercialize Relugolix
7:03 AM ET 12/28/20 | Dow Jones
By Colin Kellaher
Myovant Sciences Ltd. on Monday said it would collaborate with Pfizer Inc. to develop and commercialize relugolix in oncology and women's health in the U.S. and Canada in a deal potentially worth more than $4 billion to Myovant.
The companies plan to jointly develop and commercialize Orgovxy (relugolix) in advanced prostate cancer and, if approved, a relugolix combination tablet for women's health in the U.S. and Canada.
Myovant and Pfizer would equally share profits and certain expenses for Orgovxy and the relugolix combination tablet, with Myovant recording revenue, the company said.
Myovant said it would receive up to $4.2 billion under the deal, including an upfront payment of $650 million, $200 million in potential regulatory milestones for U.S. Food and Drug Administration approvals for the relugolix combination tablet, and tiered sales milestones.
Myovant said it would receive $50 million and be entitled to double-digit royalties on sales if Pfizer exercises an option to commercialize relugolix in oncology outside of the U.S. and Canada, excluding certain Asian countries.
Great news!!!
Myovant Sciences announces FDA approval of ORGOVYX as treatment for adult patients with advanced prostate cancer
12/18/20 | Briefing.com
The FDA has approved ORGOVYX (relugolix) for the treatment of adult patients with advanced prostate cancer. ORGOVYX, which was granted Priority Review by the FDA, is the first and only oral gonadotropin-releasing hormone receptor antagonist for men with advanced prostate cancer. The approval is based on efficacy and safety data from the Phase 3 HERO study of ORGOVYX in men with advanced prostate cancer. ORGOVYX is expected to be available in January 2021.In the Phase 3 HERO study, ORGOVYX met the primary endpoint and achieved sustained testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks in 96.7% (95% confidence interval [CI]: 94.9-97.9) of men, compared with 88.8% (95% CI: 84.6-91.8) of men receiving leuprolide acetate injections, the current standard of care.Myovant will hold a conference call on December 21 at 8:30 a.m. ET to discuss the FDA approval of ORGOVYX for men with advanced prostate cancer.
I'm sure it was baked into the run up. Now we wait for Sumitomo buyout.
Interesting day so far today.
Big day today for MYOV. Looking forward to December.
No, it's because I know actual doctors that are going to be prescribing this.
I added more today.
Kala Pharmaceuticals announces FDA Approval of EYSUVIS(TM) for the Short-Term Treatment of the Signs and Symptoms of Dry Eye Disease
-- First Approved Prescription Therapy Specifically for Short-Term Treatment of Dry Eye Disease --
-- First Ocular Corticosteroid Indicated for Dry Eye Disease --
-- Kala to Host Conference Call Today at 8:30 a.m. ET --
WATERTOWN, Mass.--(BUSINESS WIRE)--October 27, 2020--
Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that the U.S. Food and Drug Administration (FDA) has approved EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease.
"The FDA approval of EYSUVIS as the first prescription therapy specifically developed to address the short-term treatment needs of people living with dry eye disease is a major accomplishment for Kala and an important moment for patients, who have been waiting for an FDA-approved, safe, effective and fast-acting therapy," said Mark Iwicki, Chairman, President and Chief Executive Officer of Kala Pharmaceuticals. "As we prepare to launch EYSUVIS, we will leverage our strong foundation of highly experienced ophthalmology marketing, sales and market access professionals with the goal of establishing EYSUVIS as the preferred, first-line prescription therapy for dry eye disease. We'd like to thank the many patients and investigators that were involved in the clinical trials that led to this important milestone."
Dry eye disease is a chronic, episodic, multifactorial disease affecting the tears and ocular surface, and can involve tear film instability, inflammation, discomfort, visual disturbance and ocular surface damage. Approximately 80 percent of people living with dry eye disease suffer from episodic flares. These flares can be caused by a wide variety of triggers and often cannot be adequately managed with current therapies.
EYSUVIS utilizes Kala's AMPPLIFY(R) mucus-penetrating particle (MPP) Drug Delivery Technology to enhance penetration of loteprednol etabonate (LE) into target tissue on the ocular surface. LE targets the immune responses that drive acute dry eye disease flares. Prior to EYSUVIS, there were no FDA-approved ocular corticosteroids for the treatment of dry eye disease. Kala Pharmaceuticals plans to launch EYSUVIS in the U.S. by year-end.
"The approval of EYSUVIS ushers in a new era in the treatment of dry eye disease and offers promise to the millions of dry eye patients who experience acute exacerbations, or flares, of their disease each year," said Edward Holland, M.D., Director of Cornea Services at Cincinnati Eye Institute and Professor of Ophthalmology at the University of Cincinnati. "For the first time we will be able to offer dry eye patients a therapeutic option that provides rapid relief for both the signs and symptoms of the disease and that is safe and well tolerated."
"Dry eye disease can significantly decrease quality-of-life among affected patients and drive decreased workplace productivity, contact lens intolerance and discontinuation, and poor cataract and refractory surgery outcomes," said Kelly Nichols, O.D., M.P.H., Ph.D., F.A.A.O., Dean of the University of Alabama at Birmingham School of Optometry. "As the prevalence of dry eye disease increases, there is a tremendous need for new therapies to manage mild-to-moderate dry eye disease patients, many of whom currently go untreated. I am excited by the approval of EYSUVIS and confident that having access to an approved corticosteroid specifically for dry eye disease will meaningfully impact the management of patients across the U.S."
The FDA granted approval to EYSUVIS based on results from four clinical trials, including three Phase 3 trials and one Phase 2 trial, that demonstrated significant improvements in both the signs and symptoms of dry eye disease. Specifically, statistical significance was achieved after two weeks of dosing for the sign endpoint of conjunctival hyperemia in all three Phase 3 trials. Statistical significance was observed in two of the three Phase 3 trials for the symptom endpoints of ocular discomfort severity in both the overall intent-to-treat (ITT) population and in a predefined subgroup of ITT patients with more severe ocular discomfort at baseline. EYSUVIS was well-tolerated across the four trials, with adverse events and intraocular pressure increases comparable to that observed with vehicle.
As of September 30, 2020, Kala had cash, cash equivalents and short-term investments of $159.1 million. Kala anticipates that its existing cash, cash equivalents and short-term investments, along with sales of INVELTYS(R) , will enable it to fund its operations into at least the third quarter of 2022, with additional cash runway expected based on revenues from sales of EYSUVIS.
EYSUVIS(TM) Important Safety Information
EYSUVIS, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.
The initial prescription and each renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining.
Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, as well as defects in visual acuity and fields of vision. Corticosteroids should be used with caution in the presence of glaucoma. Renewal of the medication order should be made by a physician only after examination of the patient and evaluation of the IOP.
Use of corticosteroids may result in posterior subcapsular cataract formation.
Use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, corticosteroids may mask infection or enhance existing infection.
Use of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).
Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid application. Fungus invasion must be considered in any persistent corneal ulceration where a corticosteroid has been used or is in use.
The most common adverse drug reaction following the use of EYSUVIS for two weeks was instillation site pain, which was reported in 5% of patients.
Please see full Prescribing Information at www.eysuvis.com
Looking forward ti the End of October. Should be a nice run up till then.
Had some left over Chinese food from last nights dinner. So on my way home from work tonight I swung by the restaurant to grab a couple egg rolls to enjoy with my fried rice. I look in their fridge to grab a drink what do I see... Xing Tea on the top 2 shelves!
New Age Launches CBD Globally
DENVER, CO / ACCESSWIRE / April 25, 2019 / NEW AGE BEVERAGES CORPORATION (NASDAQ: NBEV), the Colorado and Utah-based organic and natural beverage company intending to become the world's leading healthy beverages and lifestyles company, today announced the global launch of their CBD product portfolio, with the unveiling of their line and shipment of their CBD creams, lotions, and oils to be sold worldwide under its Health Sciences Division.
KEY HIGHLIGHTS:
- New Age enters global CBD market with full portfolio of topicals launching globally into the Company's 60 markets worldwide throughout 2019, starting with the US on 4/25/19.
- CBD portfolio launching under the Health Sciences Division umbrella delivering the R&D, medical insight and science to provide consumers the most trusted products available
- New Age effectuating omni-channel CBD launch through all five of its channels -- direct-to consumer, direct-store-door, traditional retail, e-commerce, and medical channels
Image: https://www.accesswire.com/uploads/nbev_pic.jpg
Under the umbrella of its Health Sciences Division wholly-owned subsidiary, New Age is shipping its premium portfolio of CBD oils, creams, and lotions beginning 4/25/19, with activation across its entire global direct-to-consumer channel under its 'NHANCED brand name. The products will be sold immediately through the 30,000 North American direct-to-consumer product consultants, as well as through a new dedicated e-commerce website www.NHANCEDCBD.com to markets worldwide. The portfolio of CBD products will then roll out to Morinda's direct-to-consumer network across the more than 60 countries around the world throughout the remainder of 2019.
Concurrently, New Age also intends to launch its regular portfolio of CBD products at retail under the Health Sciences brand directly, in Private Label offerings with select retail partners, and with emerging partners in the medical channel. The Company believes the launch represents the first of its kind type of effort -- a global omni-channel approach - bringing hemp-based CBD products to consumers...within an arm's or a click's reach of desire.
New Age's CBD product line features full-spectrum CBD, which means the CBD has been distilled and stripped of lipids and fillers, but still maintains a full spectrum of CBD and other cannabinoids. This diversity in phytonutrients can facilitate the "entourage effect," which is a term used to describe synergy amongst cannabinoids. The hemp source, delicate CBD extraction, processing techniques, and the nature of the CBD itself all set the New Age CBD portfolio apart from competition. 'NHANCED CBD and the Health Sciences CBD products are sourced from hemp grown outdoors in farms located in the Pacific Northwest region of the United States. The initial launch will feature three distinct products, CBD Body Cream at 150mg strength, CBD Roll-on Gel at 200mg strength, and CBD Oil at 500mg strength. All products will only be commercialized in locations within the United States or countries that legally allow the sale and use of CBD and CBD-infused products.
Jerry Haase, M.D., Chief Medical and Scientific Officer for the New Age Health Sciences Division commented, "The Health Sciences Division has worked exhaustively bringing all of our science, patented formulas, insights and more than 10 years of study to deliver superior clinical products to consumers. Our launch of CBD leverages all of that differentiated expertise, and specific study of cannabinoids over the past number of years for the benefit of these new products." Shon Whitney, Senior Vice President of Sales and Marketing at Morinda added, "The 'NHANCED CBD brand's promise is simple, we will bring you the most researched, most efficacious, and highest quality CBD products possible, that you can trust. We will never compromise quality in sourcing, processing, safety or ingredients to deliver a superior outcome in the finest CBD products available worldwide."
New Age has recently gained distribution on a number of its core beverage brands with some of the world's largest retailers in both the convenience and mass channels. In addition, its recent growth with its Marley Brand of beverages, expansion of its agreement with the Marley Family, and recently announced partnership with Docklight on Marley CBD-Infused beverages have positioned the Company well to expand its portfolio of Marley+CBD beverages. The company has been working in close partnership with retailers in the United States, Japan, and other key markets to launch these beverages, and expects to launch these products worldwide in addition to its line of topicals as individual regulatory landscapes continue to evolve on a daily basis.
The 'NHANCED CBD line products are now available via the www.NHANCEDCBD.com website, and will also be available exclusively through Morinda's network of in-home distributors. The Health Sciences line of CBD products will be available exclusively to retail customers, brought to market through New Age's own direct-to-store distribution system and through its group of national distribution partners throughout the United States.
CBD infused beauty supplies from Morinda is my guess...
https://www.morinda.com/en-us/shop/nhancedcbd
A Grand Slam For New Age Beverages Corporation...
https://seekingalpha.com/article/4253922-grand-slam-new-age-beverages-corporation?fbclid=IwAR2EtqSGgipuWHADyGSFxzIt7GgLlMeTkgUhZ8opZanF17grMTf2EB7EcjA
NBEV Announces The Sale Of Its Japanese Office Building For $55 Million
DENVER, CO / ACCESSWIRE / April 3, 2019 / New Age Beverages Corporation (NASDAQ: NBEV), the Colorado and Utah-based organic and natural beverage company intending to become the world's leading healthy beverages and lifestyles company today announced that it has closed on the sale of its Japanese office building, with a net price for sale of the asset of $55 million.
KEY HIGHLIGHTS:
-- $55 million sale price exceeded high range of expectations. Less the $25
million owed to Morinda sellers and fees, net additional benefit to New
Age expected to exceed $12 million
-- Sale recently completed, with proceeds expected to be transferred to the
company imminently providing for additional working capital to drive
further international growth
New Age completed a reverse triangular merger with Morinda Holdings, Inc. on December 21, 2018. As part of that acquisition, New Age agreed to pay the shareholders of the business up to $25 million from the proceeds of the sale of their Japanese office building. The sale has now closed with a final sale price of $55 million. After the $25 million payment to the Morinda shareholders, payoff of the $2.9 million mortgage, fees and other transaction costs, the net additional benefit to New Age is expected to exceed $12 million.
New Age reported $42 million on its balance sheet with de minimis debt in its most recent 10K filing. The Company expects to utilize the proceeds from the sale for organic growth of its core portfolio, investment behind its CDB portfolio of products, and for incremental working capital flexibility.
Greg Gould, Chief Financial Officer for New Age commented, "The sale of the Japanese office building far exceeded our upside estimates, and creates an additional benefit to the Company of around $12 million. Coupled with the new $25 million credit facility recently emplaced with East West Bank, and the previous cash balance of more than $42 million, it puts New Age in a very strong financial position."
We should find out Monday during the conference call.
I just let it sit. Add some here and there on the dips. Will pay off soon enough.
Amyris Is Selected by NIH Grant Recipient, IDRI, to Engineer Molecules for Vaccine Adjuvant Applications
Amyris, Inc. (Nasdaq:AMRS), and IDRI (Infectious Disease Research Institute), are pleased to announce IDRI’s receipt of a $4.4 million, five-year grant from the National Institute of Allergy and Infectious Diseases (part of the U.S. National Institutes of Health) to discover sustainable alternatives to shark squalene to use as vaccine adjuvants (grant number: R01AI135673). Funding is provided by a special bioengineering research grant aimed at bringing engineering expertise to focus on a biomedical problem and ultimately develop a new solution.
Adjuvants are added to vaccines to enhance their effectiveness; the aim of the new project is to discover and evaluate novel, sustainable squalene-like compounds produced by bio- or chemical engineering for vaccine adjuvant applications.
IDRI has selected Amyris and the University of Nottingham, (UK) as partners because of their record of success in engineering pure molecules from sustainable sources at low cost. Instead of sourcing squalene from sharks, Amyris uses patented biotechnology to create squalene-like compounds using sugarcane syrup as the fermentation feedstock. Amyris has developed specific expertise as a clean manufacturer of sustainably sourced squalane.
“While one of our goals is to find a replacement for the pharmaceutical squalene derived from sharks, another key driver of this project is to understand how squalene formulations actually work as adjuvants,” said Christopher Fox, PhD, Vice President of Formulations at IDRI and principal investigator for the project. “By generating compounds with various structural alterations, we can study the structure-function relationship of squalene-like molecules and shine a light on their mechanisms of action.”
Fox added that key attributes of adjuvants in vaccines are the ability to improve an immune response and minimize the dose of vaccine necessary to confer immunity, which is particularly important where there is a disease outbreak that results in a vaccine shortage. “Development of this technology could enable formulations that effectively increase the number of vaccine doses available in the event of an influenza pandemic for example,” Fox said.
“We’re pleased to assist IDRI and to work with the University of Nottingham in this endeavor,” Amyris President, Research & Development Joel Cherry, Ph.D. said. “Today, we’re producing enormous amounts of squalane for customers around the world. This is a sustainably sourced version of squalane, with high purity and performance, and we’re looking forward to lending our assistance to apply what we know to benefit more people.”
Amyris Appoints Industry Veteran as President, Sweeteners and Ingredients, to Deliver Accelerated Growth
EMERYVILLE, Calif., Feb. 11, 2019 (GLOBE NEWSWIRE) -- Amyris, Inc. (Nasdaq:AMRS), a leader in the development and production of sustainable ingredients for the Health & Wellness, Clean Beauty and Flavors & Fragrances markets, today announced the appointment of Oreste Fieschi as President of Sweeteners & Ingredients, to lead the commercial growth of its sweetener business and the implementation of its strategy to build capability across the entire ingredients portfolio.
Oreste has a successful track record in commercial leadership roles in the food and beverage and natural ingredients sectors, along with deep expertise in global markets. This new position is driven by growth across Amyris's businesses and within the expanding market for the company's new, sugarcane-derived zero calorie sweetener.
Most recently, he led global sales and marketing as the Chief Commercial Officer for Naturex, a leader in natural ingredients recently bought by Givaudan. He has over 20 years' experience in senior commercial roles in diverse markets including chemicals, personal care, and food & beverage, including six years leading the sales growth strategy for Tate & Lyle Latin America. Prior to that, he held key commercial and business development roles with such companies as IFF, a leading developer and manufacturer of flavors and fragrances. Oreste holds a Master's degree in Business Administration from the Business School São Paulo, BSP (in partnership with Toronto University), and several other education certifications in finance and accounting, marketing, and chemical engineering.
"We welcome Oreste to Amyris at an inflection point when our businesses are experiencing solid, recurring revenue growth," said John Melo, Amyris President & CEO. "His proven experience as a successful leader in the markets we are growing, gives us a significant advantage toward maximizing the real opportunities ahead of us for revenue growth through key partnerships for our No Compromise(TM) ingredients."
Based in São Paulo and fluent in English, Portuguese and Spanish, Oreste will leverage his deep expertise globally to execute on Amyris's accelerated demand for the sweetener business.
Giant Food in MD carries Xing, Marley Mellow Mood and One Drop and Bucha.
As they always do. Shorts always have a way out.
I only blocked him for myself.