News

-- Study Showed 96.4% Sensitivity for T2Candida Panel Compared to 60% in Blood Culture in Review of 55 Candida Cases -- LEXINGTON, Mass., Sept. 16, 2015 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (Nasdaq:TTOO), a company developing innovative diagnostic products to improve patient health, today announced that results from a data analysis of the company's T2Candida® Panel for the detection and monitoring of Candida infection and sepsis were published in Future Microbiology. The publication compared aggregated results from T2Candida in the detection of invasive candidiasis and candidemia to blood culture, which included samples acquired from more than 1,900 patients. Out of 55 total cases, T2Candida demonstrated a 96.4 percent sensitivity (53 cases) compared to 60 percent (33 cases) with blood culture.

DURHAM, N.C., Sept. 14, 2015 (GLOBE NEWSWIRE) -- Chimerix, Inc. (NASDAQ:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced an extension of its contract with the Biomedical Advanced Research and Development Authority (BARDA) for the development of the broad spectrum antiviral, brincidofovir, as a medical countermeasure to treat smallpox.

The Phase 3 Safety Study and the Ongoing Phase 3 Efficacy Study will Form the Basis for the Expected NDA Submission Near the End of 2016 TORONTO – Cynapsus Therapeutics Inc. (NASDAQ: CYNA) (TSX: CTH) (the “Company”) today announced enrollment of the first patient in the CTH-301 clinical trial, a pivotal Phase 3 study to examine the safety and tolerability of APL-130277 for the acute treatment of OFF episodes in patients with Parkinson's disease (PD). CTH-300, a pivotal Phase 3 efficacy study, is also ongoing with data expected from both trials in 2016.

Total Financing in Last Two Months Reaches Up To Almost $80 Million CLEVELAND, August 19, 2015 — ViewRay, Inc. (OTCQB:VRAY) announced today the completion of its private placement offering as part of its alternative public offering announced on July 23, 2015. Shares of the company’s common stock are currently quoted on the OTC Markets under the symbol “VRAY.”

CHAPEL HILL, N.C., Aug. 19, 2015 (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 U.S. Food and Drug Administration (FDA) has granted Fast Track designation for solithromycin intravenous (IV) and capsules for the treatment of community acquired bacterial pneumonia (CABP). Solithromycin is currently in Phase 3 development for the treatment of CABP and submission of a New Drug Application (NDA) is planned for 2016. Additional clinical studies with solithromycin include a Phase 3 trial in uncomplicated gonorrhea that is expected to complete patient enrollment by the end of 2015, a Phase 2 trial in chronic obstructive pulmonary disease (COPD), a Phase 2 trial in nonalcoholic steatohepatitis (NASH), and a Phase 1b trial in pediatric patients.

MENLO PARK, Calif.--(BUSINESS WIRE)--Intersect ENT, Inc. (Nasdaq:XENT), a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, today announced preliminary results of PROGRESS, a prospective, randomized, blinded, multi-center trial to assess the safety and efficacy of the PROPEL® mini steroid releasing sinus implant when used following frontal sinus surgery.

NEW YORK, Aug. 10, 2015 /PRNewswire/ -- Aisling Capital, a leading investment firm that invests in companies developing and commercializing important and innovative healthcare products, services and technologies, announced that Scott Braunstein, MD has joined the firm as an Operating Partner. Dr. Braunstein will assist in evaluating potential future investments for the firm, as well as working broadly with Aisling portfolio companies. "Scott has over 25 years of experience in the healthcare industry in a variety of clinical, business, strategy, product and technology leadership roles. We are delighted to welcome him to Aisling Capital," said Drew Schiff, MD, Managing Partner at Aisling Capital. "In his new role, Scott will contribute his unique insights and perspectives to our late-stage private equity investment strategies." Dr. Braunstein serves as Senior Vice President, Strategy and Corporate Development at Pacira Pharmaceuticals. He spent 12 years as a Healthcare Analyst and Portfolio Manager at J.P. Morgan Asset Management, where he invested in and conducted diligence on a wide variety of pharmaceutical products and product candidates. He reviewed pharmaceutical company strategies, business models and management teams, and provided stock recommendations for the J.P. Morgan Asset Equity Group. "I am very excited to join Aisling Capital and its talented team," said Dr. Braunstein. "I am looking forward to working across the firm's impressive portfolio of healthcare companies to help them better meet their business objectives, as well as identifying new investment opportunities." Dr. Braunstein serves as a director of Esperion Therapeutics (Nasdaq: ESPR), STAT Medical and the Cornell Alumni Association for the College of Agriculture and Life Sciences. Dr. Braunstein received his M.D. from the Albert Einstein College of Medicine and completed his residency in internal medicine at Cornell University-New York Hospital. He received his B.S. from Cornell University.

BRISBANE, Calif.--(BUSINESS WIRE)--Aug. 5, 2015-- Aimmune Therapeutics, Inc. today announced the pricing of its initial public offering of 10,000,000 shares of its common stock at a public offering price of $16.00 per share, before underwriting discounts and commissions. In addition, Aimmune has granted the underwriters a 30-day option to purchase up to an additional 1,499,999 shares of common stock at the same price. Aimmune’s common stock is expected to begin trading on The NASDAQ Global Select Market on August 6, 2015 under the symbol AIMT.

Two Identical Studies to Enroll a Combined Total of 660 Patients Topline Phase 3 Data Expected in the Second Half of 2016 Represents Dermira's Second Product Candidate in Phase 3 Development Dermira Updates 2015 Financial Guidance MENLO PARK, Calif., Aug. 3, 2015 (GLOBE NEWSWIRE) -- Dermira, Inc. (NASDAQ:DERM), a specialty biopharmaceutical company focused on bringing innovative and differentiated products to dermatologists and their patients, today announced the initial dosing of the first patients in a Phase 3 program for DRM04 in patients with axillary hyperhidrosis (excessive underarm sweating). The DRM04 Phase 3 program consists of two identical, randomized, double-blind, vehicle-controlled studies, ATMOS-1 and ATMOS-2, each enrolling approximately 330 patients. The program is designed to assess the safety and efficacy of DRM04 compared to vehicle to support a potential New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA).

SAN DIEGO--(BUSINESS WIRE)--Aug. 3, 2015-- Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company developing novel anti-infectives and immunotherapies to treat fungal and other infections, today announced the initiation of a Phase 1, randomized, double-blind, dose-escalation study to determine the safety, tolerability, and pharmacokinetics of CD101 IV in healthy subjects.