News

LEXINGTON, Mass., Nov. 01, 2016 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a company developing innovative diagnostic products to improve patient health, today announced a collaboration with Allergan to develop a novel diagnostic panel to detect Gram-negative bacterial species and antibiotic resistance for patients with serious bacterial infections, including infections leading to sepsis. These products will expand T2 Biosystems’ sepsis pipeline and will include the first direct-from-blood diagnostic panel to detect antimicrobial resistance.

NEW HAVEN, Conn., Nov. 1, 2016 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. ("Biohaven"), a privately-held biopharmaceutical company with particular expertise in late stage clinical development and a portfolio of multiple late stage assets, announced today the successful completion of an oversubscribed $80 million private financing. The round was led by Venrock and joined by other leading biotech investors including RA Capital Management, Vivo Capital, Aisling Capital, Rock Springs Capital, John W. Childs, Knoll Capital Management, Osage University Partners, Aperture Venture Partners, Connecticut Innovations, Greg Bailey and Litmore Capital. Two undisclosed blue chip pharmaceutical companies also participated in the round as part of in-licensing agreements with Biohaven.

MALVERN, Pa., Oct. 31, 2016 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), today announced that it has submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for its drug candidate ATI-50001 for the treatment of alopecia universalis and alopecia totalis.  Aclaris plans to conduct a human pharmacokinetic/pharmacodynamic (pK/pD) study to evaluate the safety of ATI-50001 in healthy volunteers.

SOUTH SAN FRANCISCO, Calif., Oct. 24, 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 that it has reached agreement with the U. S. Food and Drug Administration (FDA) regarding the design of its pivotal trial for GBT440 in adults and adolescents with sickle cell disease (SCD). The Phase 3 HOPE (Hemoglobin Oxygen Affinity Modulation to Inhibit HbS PolymErization) Study will be conducted at leading SCD sites globally and will enroll adults and adolescents with SCD who have had at least one episode of vaso-occlusive crisis (VOC) in the previous year. The HOPE Study is expected to begin screening patients by December with top-line data anticipated in the first half of 2019.

MALVERN, Pa., Oct. 19, 2016 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS) today announced results from an observational  study that found patients with asymptomatic seborrheic keratosis (SK) are bothered by their highly visible skin lesions and very interested in treatment options to improve their appearance, even if a cost were associated with treatment. The study was conducted in dermatology practices by Burke, Inc. on behalf of Aclaris.

Menlo Park, Calif.– October 17 – Intersect ENT, Inc. (Nasdaq:XENT), a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, today announced positive results from RESOLVE II, a randomized, blinded, multi-center clinical trial designed to assess the safety and efficacy of the company’s investigational RESOLVE steroid releasing implant.

NEW YORK--(BUSINESS WIRE)--Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today presented new long-term safety data of plecanatide, its investigational, orally-administered compound currently being evaluated by the U.S. Food and Drug Administration (FDA) for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). These data, which were presented at the American College of Gastroenterology (ACG) annual scientific meeting, showed that plecanatide was associated with low adverse events and low discontinuation rates in patients with CIC who received plecanatide (3 mg or 6 mg) once-daily for up to 72 weeks.

ANN ARBOR, Mich., Oct. 13, 2016 (GLOBE NEWSWIRE) -- Esperion Therapeutics, Inc. (NASDAQ:ESPR), a pharmaceutical company focused on developing and commercializing oral therapies for the treatment of patients with elevated low density lipoprotein cholesterol (LDL-C), today announced the bempedoic acid global pivotal Phase 3 LDL-C lowering clinical development program will include patients with hypercholesterolemia on any statin at any dose based on positive top-line results from its Phase 2 pharmacokinetics and pharmacodynamics (PK/PD) study of bempedoic acid added to atorvastatin 80 mg (1002-035), and the previously completed Phase 1 and Phase 2 studies.

CHAPEL HILL, N.C., Sept. 29, 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 interim results showing anti-NASH effects in the first six nonalcoholic steatohepatitis (NASH) patients dosed with solithromycin in a Phase 2 study.

MENLO PARK, Calif., Sept. 26, 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 initiation of the Phase 3 portion of its J14VR5 trial in Japanese children with GHD following the completion of the Phase 2 portion of the trial. Versartis noted the following: