Tag: biopharmaceutical

Retrophin to Present at the Leerink Partners Rare Disease & Immuno-Oncology Roundtable Series

SAN DIEGO, Sept. 14, 2016 (GLOBE NEWSWIRE) — Retrophin, Inc. (Nasdaq:RTRX) today announced that Alvin Shih, M.D., executive vice president and head of research & development, will present at the Leerink Partners Rare Disease & Immuno-Oncology Roundtable Series in New York City on Wednesday, September 28, 2016 at 11:05 a.m. ET. A live webcast of the presentation will be available at http://ir.retrophin.com/events.cfm and an archived replay will be accessible for up to 90 days.            About Retrophin Retrophin is a fully integrated biopharmaceutical company dedicated to delivering life-changing therapies to people living with rare diseases who have few, if any, treatment options. The Company’s

Proteostasis Therapeutics Announces Closing of Follow-On Public Offering of Common Stock

CAMBRIDGE, Mass., Sept. 14, 2016 (GLOBE NEWSWIRE) — Proteostasis Therapeutics, Inc. (NASDAQ:PTI), a biopharmaceutical company developing small molecule therapeutics to treat diseases caused by dysfunctional protein processing such as cystic fibrosis, today announced the closing of its follow-on public offering of 5,000,000 shares of its common stock at a public offering price of $13.00 per share, before the underwriting discount. All of the shares sold were offered by Proteostasis Therapeutics, Inc. The gross proceeds from the offering are $65 million, before deducting the underwriting discount and expenses associated with the offering payable by the company. In addition, the company has granted

Global Blood Therapeutics Announces Publication of Preclinical Results Supporting GBT440 Program for Hypoxemic Pulmonary Disorders

SOUTH SAN FRANCISCO, Calif., Sept. 14, 2016 (GLOBE NEWSWIRE) — Global Blood Therapeutics, Inc. (GBT) (NASDAQ:GBT), a biopharmaceutical company developing novel therapeutics for the treatment of grievous blood-based disorders with significant unmet need, today announced publication of preclinical data supporting the development of GBT440 for the treatment of hypoxemic pulmonary disorders, including idiopathic pulmonary fibrosis (IPF), in Physiological Reports. To date, GBT has established preclinical proof of concept for GBT1118, a hemoglobin modifier and analog of GBT440, in three different animal models of hypoxia. Data from these models support the potential beneficial effects of hemoglobin modification as a promising therapeutic strategy

Rexahn Announces $6 Million Registered Direct Offering

ROCKVILLE, Md., Sept. 14, 2016 (GLOBE NEWSWIRE) — Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN) today announced it has entered into a definitive agreement with institutional investors to purchase 24 million shares of its common stock and warrants exercisable for up to 18 million shares of its common stock for gross proceeds of $6 million.  The shares and warrants are being sold in units, each consisting of one share of common stock and a warrant to purchase 0.75 of a share of common stock, at an offering price of $0.25 per unit. The warrants will be exercisable six months following the date

INC Research and CISCRP Announce Finalists for “Inspiring Hope” Ideathon

RALEIGH, N.C., Sept. 14, 2016 (GLOBE NEWSWIRE) — INC Research Holdings, Inc. (Nasdaq:INCR), a leading, global Phase I to IV contract research organization, together with the Center for Information and Study on Clinical Research Participation (CISCRP), a non-profit organization dedicated to engaging the public and patients as partners in the clinical research process, today announced the finalists for the “Inspiring Hope” Ideathon event. In a competition that inspired nearly 70 entries, 14 ideas submitted by teams from around the world have been shortlisted for their potential to help address the critical need to increase awareness of clinical trial participation among

Anavex to Participate in Mizuho Therapeutics Conference

NEW YORK, Sept. 14, 2016 (GLOBE NEWSWIRE) — Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq:AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, today announced that Christopher U. Missling, PhD, President and Chief Executive Officer, will participate in Mizuho Therapeutics Conference on Wednesday, September 21, 2016. The conference will be held at the Langham Hotel in Boston, Massachusetts. Investors interested in attending may contact the conference organizers or Anavex Investor Relations. About Anavex Life Sciences Corp.

Xenon Pharmaceuticals Announces Exercise in Full of Option to Purchase Additional Shares and Closing of $34.5 Million Public Offering

BURNABY, British Columbia, Sept. 13, 2016 (GLOBE NEWSWIRE) — Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a clinical-stage biopharmaceutical company, today announced that the underwriters of the previously announced public offering of its common shares have exercised in full their option to purchase an additional 600,000 common shares, consisting of 450,000 common shares from Xenon and 150,000 common shares from the selling securityholders named in the final prospectus supplement for the offering. The closing of the sale of all common shares occurred today. Gross proceeds from the offering of an aggregate of 3,450,000 common shares by Xenon and the offering of an aggregate of

BioXcel’s BXCL101, Receives Orphan Drug Designation from the U.S. FDA for the Treatment of Patients with Neurofibromatosis Type 2 (NF2)

BRANFORD, Conn., Sept. 13, 2016 (GLOBE NEWSWIRE) — BioXcel, a privately held biopharmaceutical company based in Connecticut, today announced that the U. S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BXCL101 for the treatment of Neurofibromatosis Type 2 (NF2), an orphan disease with significant unmet medical need.  BXCL101 is the first and only systemic therapy being developed to eliminate existing lesions and prevent the formation of new lesions by targeting the molecular mechanism of NF2 pathophysiology. BXCL101 is a proprietary version of an approved drug, bortezomib, adapted for chronic use in NF2 patients with both a

Matinas BioPharma Completes Private Placement of $8.0 Million

BEDMINSTER, N.J., Sept. 13, 2016 (GLOBE NEWSWIRE) — Matinas BioPharma Holdings, Inc. (“Matinas BioPharma” or the “Company”) (OTCQB:MTNB), a clinical-stage biopharmaceutical company focused on identifying and developing safe and effective broad spectrum therapeutics for the treatment of serious and life-threatening infections, today announced the final closing of an $8.0 million private placement equity financing, which represents the full amount of the offering. The Company sold to accredited investors an aggregate of 1,600,000 Series A Preferred Shares at a purchase price of $5.00 per share. The net proceeds to the Company from the offering were approximately $6.9 million. The net proceeds

Arbutus’ Chief Scientific Officer, Dr. Michael J. Sofia, Awarded the 2016 Lasker~DeBakey Clinical Medical Research Award

VANCOUVER, British Columbia and DOYLESTOWN, Pa., Sept. 13, 2016 (GLOBE NEWSWIRE) — Arbutus Biopharma Corporation (Nasdaq:ABUS), an industry-leading Hepatitis B Virus (HBV) therapeutic solutions company, today announced that Dr. Michael J. Sofia, Arbutus’ Chief Scientific Officer, has been awarded the 2016 Lasker~DeBakey Clinical Medical Research Award for the development of a revolutionary treatment of hepatitis C virus (HCV). Dr. Sofia now leads a world class team of scientists at Arbutus that is focused on developing innovative therapies to improve cure rates in HBV. “It is a tremendous honor to receive the Lasker~DeBakey Award for Clinical Medical Research, in recognition of

NanoString Technologies Appoints Kirk Malloy, Ph.D. to Board of Directors

SEATTLE, Sept. 13, 2016 (GLOBE NEWSWIRE) — NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced the appointment of Kirk Malloy, Ph.D. to the company’s Board of Directors, effective September 12, 2016.  The Board now consists of seven members.  Dr. Malloy is a senior healthcare executive with more than 20 years of leadership in life science tools, applied markets and molecular diagnostics. He is currently founder and principal at BioAdvisors, LLC where he provides strategic consulting services to life science, genomic and diagnostic companies. His previous experience includes a 13-year

Fortress Biotech Completes Tender Offer for Shares of National Holdings Corporation

NEW YORK, Sept. 12, 2016 (GLOBE NEWSWIRE) — Fortress Biotech, Inc. (NASDAQ:FBIO) (“Fortress” or “FBIO”) and National Holdings Corporation (NASDAQ:NHLD) (“NHLD”) today announced that an affiliate of Fortress, FBIO Acquisition, Inc., has completed its previously announced tender offer (the “Offer”) to purchase all outstanding shares of NHLD for $3.25 per share, net to the seller in cash but subject to any required withholding of taxes. The Offer expired at 12:00 midnight, New York City time, at the end of Friday, September 9, 2016. As of the expiration of the Offer, a total of 6,748,868 shares were validly tendered and not withdrawn

Flexion Therapeutics Announces Two Key Corporate Appointments

BURLINGTON, Mass., Sept. 12, 2016 (GLOBE NEWSWIRE) — Flexion Therapeutics, Inc. (Nasdaq:FLXN) announced today that it has made two key appointments to its leadership team: Carolyn Beaty Scimemi, Esq., an experienced compliance and legal professional, as Chief Compliance Officer, and Adam Muzikant, Ph.D., a veteran biotechnology deal negotiator and strategist, as Vice President, Business Development. Ms. Scimemi and Dr. Muzikant join the Flexion leadership team as the company prepares to submit a planned new drug application (NDA) in the fourth quarter of 2016 to the U.S. Food and Drug Administration (FDA) for its drug candidate Zilretta™ (also known as FX006),

Versartis Presents Data From Up to 30 Months of Somavaratan Treatment for Pediatric Growth Hormone Deficiency at the 2016 ESPE Annual Meeting

MENLO PARK, Calif., Sept. 12, 2016 (GLOBE NEWSWIRE) — Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan (VRS-317), a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), today announced that efficacy, safety, and adherence data from up to 30 months of somavaratan treatment in the Phase 2a trial and VISTA long-term safety study for pediatric GHD were presented during the 55th Annual Meeting of the European Society of Paediatric Endocrinology (ESPE). The meeting was held September 10-12, 2016, in Paris.  “We are pleased to see that the safety profile of somavaratan

TESARO Receives FDA Fast Track Designation for Niraparib and Initiates Rolling NDA Submission

WALTHAM, Mass., Sept. 12, 2016 (GLOBE NEWSWIRE) — TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to niraparib for the treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer. TESARO has initiated a rolling submission of a New Drug Application (NDA) for niraparib to the FDA, and intends to complete this submission during the fourth quarter. The Marketing Authorization Application (MAA) for niraparib is planned for submission to the European Medicines Agency (EMA) in the fourth quarter. The FDA Fast Track designation

Geron Provides Update on Imetelstat Trials Being Conducted by Janssen

MENLO PARK, Calif., Sept. 12, 2016 (GLOBE NEWSWIRE) — Geron Corporation (Nasdaq:GERN) today provided updates on the clinical trials being conducted by Janssen Research & Development, LLC, of the telomerase inhibitor imetelstat. Planned internal reviews of initial data from both trials have been completed by Janssen, and both trials are continuing in order to evaluate additional and more mature data. IMbarkTM IMbarkTM (NCT02426086) was originally designed as a Phase 2 clinical trial to evaluate two dose levels of imetelstat (either 4.7 mg/kg or 9.4 mg/kg administered every three weeks) in approximately 200 patients (approximately 100 patients per dosing arm) with

Takeda and MacroGenics Announce the Conclusion of their MGD010 License and Option Agreement

Rockville, MD, Sept. 12, 2016 (GLOBE NEWSWIRE) — and Osaka, Japan, Sept. 12, 2016 — MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, and Takeda Pharmaceutical Company Limited (TSE: 4502) today announced the conclusion of their License and Option Agreement for MGD010. MacroGenics has regained the worldwide rights to MGD010, a bispecific molecule targeting CD32B and CD79B. Takeda’s decision comes earlier than the predefined expiration of its option exercise period and follows Takeda’s recently announced therapeutic area re-prioritization.

Athersys Announces Acceptance by PMDA of Clinical Trial Notification in Japan for Treatment of Ischemic Stroke With MultiStem®

CLEVELAND, Sept. 12, 2016 (GLOBE NEWSWIRE) — Athersys, Inc. (Nasdaq:ATHX) announced today the successful completion of Japan’s Pharmaceutical and Medical Devices Agency (PMDA) review of the Clinical Trial Notification (CTN), allowing the commencement by HEALIOS K.K. (Healios) of a confirmatory clinical trial evaluating the safety and efficacy of administration of MultiStem®, Athersys’ novel cell therapy product, for the treatment of ischemic stroke in Japan (also designated by Healios as HLCM051 in Japan).  In accordance with the regulatory system in Japan, a CTN is equivalent to an Investigational New Drug application, or IND, under the regulatory system used in the United

Sunesis Presents Dose Escalation Results from the Phase 1A Healthy Volunteer Study Evaluating Oral Non-Covalent BTK inhibitor SNS-062

SOUTH SAN FRANCISCO, Calif., Sept. 12, 2016 (GLOBE NEWSWIRE) — Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced results from the Company’s Phase 1A study in healthy volunteers evaluating oral non-covalent BTK inhibitor SNS-062. The study demonstrated a favorable safety, pharmacokinetic (PK) and pharmacodynamic (PD) profile for SNS-062 in healthy subjects. The results were presented on Saturday, September 10th at the European School of Haematology’s (ESH) 2nd International Conference on New Concepts in B-Cell Malignancies at the Estoril Congress Centre in Estoril, Portugal. “Our first-in-human clinical results are encouraging and reinforce our belief that SNS-062 has the potential to become an important

Amarin’s REDUCE-IT Cardiovascular Outcomes Study of Vascepa to Continue as Planned at Recommendation of Independent Data Monitoring Committee

BEDMINSTER, N.J. and DUBLIN, Ireland, Sept. 12, 2016 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) announced that, as expected, the independent data monitoring committee (DMC) has completed its review of the first pre-specified interim efficacy analysis for the REDUCE-IT cardiovascular outcomes study and has recommended that the trial continue as planned without modification. The 8,175-patient outcomes study is evaluating whether treatment with Vascepa® (icosapent ethyl) reduces cardiovascular events in patients who despite stabilized statin therapy have elevated triglyceride levels and other cardiovascular risk factors. In accordance with the study protocol, the first interim efficacy analysis was performed after adjudication of