News

MALVERN, Pa., Aug. 18, 2016 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage specialty pharmaceutical company, today announced positive results from its Phase 2 clinical trial (WART-201), of A-101 Topical solution (A-101) for the treatment of common warts (verruca vulgaris).  A-101 is a proprietary formulation of high-concentration hydrogen peroxide currently under development as a prescription treatment for common warts.

TORONTO, Aug. 15, 2016 (GLOBE NEWSWIRE) -- Cynapsus Therapeutics Inc. (NASDAQ:CYNA) (TSX:CTH), a specialty central nervous system (CNS) pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with Parkinson’s disease (PD), announced today that its Data Safety and Monitoring Board (DSMB) has completed a review of the safety data from the Company’s Phase 3 program including both the CTH-300 and CTH-301 clinical trials. Based on the DSMB’s recommendations, the CTH-300 trial will continue as planned. In addition, as a result of the DSMB’s review of the early safety data from both CTH-300 and CTH-301, the six-month open label CTH-301 study will be amended to allow for at-home titration, after the patient’s initial visit to the clinic.

MILPITAS, Calif., Aug. 10, 2016 /PRNewswire/ -- Protagonist Therapeutics, Inc. (NASDAQ: PTGX), a clinical-stage biopharmaceutical company with a proprietary technology platform focused on discovering and developing peptide-based new chemical entities to address significant unmet medical needs, today announced the pricing of its initial public offering of 7,500,000 shares of common stock, at a price to the public of $12 per share, before underwriting discounts and commissions. The shares are expected to begin trading on The NASDAQ Global Market on August 11, 2016, under the symbol "PTGX." In addition, Protagonist has granted the underwriters a 30-day option to purchase up to 1,125,000 additional shares at the initial public offering price, less underwriting discounts and commissions. This offering is expected to close on August 16, 2016, subject to customary closing conditions.

TOKYO and MENLO PARK, Calif., Aug. 09, 2016 (GLOBE NEWSWIRE) -- Teijin Limited (TSE:3401) and Versartis, Inc. (NASDAQ:VSAR) today announced that the companies and their wholly owned subsidiaries (collectively "Teijin" and "Versartis", respectively) have entered into an exclusive license and supply agreement for the development and commercialization of somavaratan (VRS-317) in Japan.  Versartis, an endocrine-focused biopharmaceutical company, has been developing somavaratan, a novel, long-acting form of rhGH, for pediatric and adult growth hormone deficiency (GHD) in Japan.  Teijin Pharma Limited, the core company of the Teijin Group's medical and pharmaceutical business, markets a variety of pharmaceutical products throughout Japan, including in the areas of metabolic and endocrine disease.

NEW YORK-- Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced it has reached the Food and Drug Administration (FDA) mid-cycle review milestone for the plecanatide new drug application (NDA) in chronic idiopathic constipation (CIC). Additionally, the company is providing an update on the ongoing irritable bowel syndrome with constipation (IBS-C) program.

STAMFORD, Conn., July 13, 2016 (GLOBE NEWSWIRE) -- Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to LOXO-101, a selective inhibitor of tropomyosin receptor kinase (TRK), “for the treatment of unresectable or metastatic solid tumors with NTRK-fusion proteins in adult and pediatric patients who require systemic therapy and who have either progressed following prior treatment or who have no acceptable alternative treatments.”

PLEASANTON, CA -- (Marketwired) -- 07/13/16 -- ZELTIQ^® Aesthetics, Inc. (NASDAQ: ZLTQ), a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology, today announced that it received approval from the China Food and Drug Administration (CFDA) for fat layer reduction of the abdomen and flanks. Comprehensive multi-center clinical studies have validated that the CoolSculpting^® procedure non-invasively reduces fat cells by an average of 20-25% in the treated area based on histological and ultrasound assessment.

PRINCETON, N.J., July 12, 2016 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq:AGRX), a women's health specialty pharmaceutical company focused on the development and commercialization of new prescription contraceptive products, today announced that preparations are underway for an initial Phase 2 clinical trial of a novel contraceptive regimen, which will begin the development of its pipeline beyond its current lead product candidate, Twirla^®, a once weekly contraceptive patch currently in phase 3 development. The planned Phase 2 clinical trial will examine the use of Twirla in an innovative regimen designed to allow women to experience shorter, lighter periods.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 29, 2016-- Syros Pharmaceuticals today announced the pricing of its initial public offering of 4,000,000 shares of its common stock at a public offering price of $12.50 per share, before underwriting discounts and commissions. In addition, Syros has granted the underwriters a 30-day option to purchase up to 600,000 additional shares of common stock from Syros at the public offering price, less the underwriting discount and commissions, to cover over-allotments, if any. All of the shares are being offered by Syros Pharmaceuticals. The Company’s shares are scheduled to begin trading on The NASDAQ Global Select Market on June 30, 2016 under the ticker symbol “SYRS.” The offering is expected to close on July 6, 2016, subject to customary closing conditions.

SOUTH SAN FRANCISCO, Calif., June 29, 2016 /PRNewswire/ -- Global Blood Therapeutics, Inc. (GBT) (NASDAQ: GBT), a biopharmaceutical company developing novel therapeutics for the treatment of grievous blood-based disorders with significant unmet needs, today announced it has initiated a Phase 2a study of GBT440 in adolescents with sickle cell disease (SCD). GBT is developing GBT440 as a potential disease-modifying therapy for SCD.