News

MENLO PARK, Calif.--(BUSINESS WIRE)--Spirox™, Inc., a company committed to transforming treatment of nasal obstruction, today announced positive results from a prospective, multi-center study of the LATERA™ Absorbable Nasal Implant. The study showed that the device provides a significant reduction in nasal obstruction symptoms in patients with nasal valve collapse—an important, but often overlooked, cause of nasal obstruction—and that early improvements were maintained through one year. The results were selected for presentation as one of the 10 “Best of Orals” sessions, out of 700 submissions, at the 2016 Annual Meeting of the American Academy of Otolaryngology-Head and Neck Surgery.

MENLO PARK, Calif.--(BUSINESS WIRE)--Intersect ENT, Inc. (NASDAQ:XENT) announced the publication of a position statement from the American Rhinologic Society (ARS) endorsing the utilization of drug eluting sinus implants.

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 55^th Annual Meeting of the European Society of Paediatric Endocrinology (ESPE). The meeting was held September 10-12, 2016, in Paris.

MENLO PARK, Calif., Sept. 02, 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 data on efficacy, safety (including metabolic parameters), and treatment adherence from up to 30 months of somavaratan treatment in the pediatric long-term safety study (now named VISTA), were presented during the 17th International Congress of Endocrinology, being held August 31 to September 4, 2016, in Beijing. Highlights from the three oral presentations include:

MARLBOROUGH, Mass. & TORONTO--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) and Cynapsus Therapeutics Inc. (Cynapsus) (NASDAQ: CYNA) (TSX: CTH) today announced that the companies have signed a definitive agreement under which Sunovion will acquire Cynapsus for US$40.50 per share in cash. The transaction has received unanimous approval by the Board of Directors of both companies and values Cynapsus at approximately US$624 million (or approximately CAN$820 million). The acquisition will be funded with cash on hand. The transaction is expected to close in the fourth quarter of 2016 (third quarter of Sunovion’s fiscal year). This agreement reflects Sunovion’s global strategy to expand and diversify its portfolio in key therapeutic areas, including neurology.

TORONTO, Aug. 29, 2016 (GLOBE NEWSWIRE) -- Cynapsus Therapeutics Inc. (NASDAQ:CYNA) (TSX:CTH), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for APL-130277, a product candidate for the treatment of OFF episodes in patients with Parkinson’s disease (PD).

CHAPEL HILL, N.C., Aug. 23, 2016 (GLOBE NEWSWIRE) -- Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced that the European Medicines Agency (EMA) has validated the company's marketing authorization application (MAA) seeking approval of oral capsule and intravenous formulations of solithromycin for the treatment of community-acquired bacterial pneumonia (CABP, also referred to as community-acquired pneumonia (CAP) in the EU).

MENLO PARK, Calif., Aug. 22, 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 the completion of enrollment in the Phase 3 VELOCITY trial of somavaratan in pediatric GHD. With 137 patients enrolled, the trial is powered at > 90% to demonstrate non-inferiority of somavaratan compared to daily rhGH. Patients will be followed for the primary trial endpoint of height velocity at 12 months, as well as safety and pharmacodynamic secondary endpoints. Top-line results are anticipated in Q3 2017.

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.