News

Topline Results for Phase 3 ATMOS-1 and ATMOS-2 Clinical Trials Expected in 2Q 2016 MENLO PARK, Calif., Feb. 29, 2016 (GLOBE NEWSWIRE) -- Dermira, Inc. (NASDAQ:DERM), a biopharmaceutical company dedicated to identifying, developing and commercializing innovative, differentiated therapies to improve the lives of patients with dermatologic diseases, today announced the completion of patient enrollment in its Phase 3 ATMOS-1 and ATMOS-2 clinical trials for DRM04 in primary axillary hyperhidrosis (excessive underarm sweating). Based on enrollment completing ahead of schedule, Dermira now expects to announce topline efficacy and safety data for both of these trials during the second quarter of 2016, compared with previous guidance of mid-2016.

RAMSEY, N.J., Feb. 24, 2016 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical company that develops, manufactures and intends to commercialize specialty plasma-based biologics for the treatment and prevention of certain infectious diseases, announced today that the Company has been recognized as one of New Jersey’s “100 Best Places to Work 2016” by the Best Companies Group, a company dedicated to identifying and recognizing places of employment that are leading the way in defining the employee experience, and NJBIZ, a leading New Jersey-focused weekly business news publication.

Brincidofovir Shows On-Treatment Antiviral Effect in HCT Setting Despite Trial Not Meeting Primary Endpoint Company to Host Conference Call on February 22 at 8:00 a.m. EST to Provide Additional Analyses and Plans for Further Clinical Development DURHAM, N.C., Feb. 20, 2016 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced detailed results from its Phase 3 SUPPRESS trial of brincidofovir for the prevention of cytomegalovirus (CMV) in patients undergoing hematopoietic cell transplantation (HCT).

CAMBRIDGE, Mass. & NEW YORK--(BUSINESS WIRE)-- BIND Therapeutics, Inc. (NASDAQ: BIND), a clinical-stage nanomedicine company developing targeted and programmable therapeutics called ACCURINS®, and Synergy Pharmaceuticals Inc. (NASDAQ: SGYP), a biopharmaceutical company pioneering the development of uroguanylin analogs as potential new treatments for functional gastrointestinal (GI) disorders and inflammatory bowel disease (IBD), today announced they have entered into a research collaboration to engineer ACCURINS® incorporating Synergy’s proprietary uroguanylin analogs to explore the potential targeting of guanylate cyclase-C (GC-C) receptors expressed on tumors, specifically GI malignancies. Upon achievement of proof-of-concept, the companies anticipate expanding the collaboration to enhance the potential effect of uroguanylin-based ACCURINS® by incorporating therapeutic payloads.

- Continue to anticipate SurgiBot FDA clearance by the end of the first quarter of 2016 - - Strengthens balance sheet with $18M of equity raised - RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- TransEnterix, Inc. (NYSE MKT: TRXC), a medical device company that is pioneering the use of robotics and flexible instruments to improve minimally invasive surgery, today announced the following:

• Completes FDA Response. TransEnterix has successfully completed its response to the U.S. Food and Drug Administration (FDA) related to the pending 510(k) application submitted for clearance of the company's SurgiBot™ System.
• Strengthens Balance Sheet. Since September 30, 2015, the Company has raised $18 million(1) in net proceeds at an average price of $3.23 per share under its $25 million "at-the-market" (ATM) equity sales facility that was established in February 2015. There is no further availability under this facility. The proceeds from these sales will be utilized to continue to support investments for the commercialization of the ALF-X® system in Europe, as well as the SurgiBot in the United States, following FDA clearance.
• Files New ATM Facility. Following the successful completion of the prior ATM facility, the Company has entered into a new ATM facility that allows it the option to raise up to $43.6 million in equity from time to time through January 2017. The Company has no obligation to sell any shares under this facility.

Orphan designation follows QIDP and Fast Track status for CD101 IV SAN DIEGO--(BUSINESS WIRE)--Feb. 10, 2016-- Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company developing novel anti-infectives and immunotherapies to treat fungal and other infections, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its antifungal drug candidate, CD101 IV, for the treatment of candidemia and invasive candidiasis.

100 Percent Survival Demonstrated in Animals Treated Immediately With Brincidofovir at Time of Confirmed Infection DURHAM, N.C., Feb. 08, 2016 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today presented positive results from a pivotal study of its antiviral, brincidofovir, in an animal model for smallpox at the ASM Biodefense and Emerging Diseases Research Meeting in Arlington, Virginia.

Solithromycin met primary and secondary objectives of non-inferiority compared to moxifloxacin, a potent fluoroquinolone Cempra plans to complete a New Drug Application (NDA) submission to the FDA for the treatment of CABP during the first half of 2016 The FDA has granted Fast Track designation for solithromycin IV and capsules for the treatment of CABP CHAPEL HILL, N.C., Feb. 05, 2016 (GLOBE NEWSWIRE) -- Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics in the face of rising antibiotic resistant bacterial infections, today announced the publication of positive results from its pivotal Phase 3 clinical trial of solithromycin oral capsules in the treatment of patients with community-acquired bacterial pneumonia (CABP) in The Lancet Infectious Diseases. The article, titled, "Efficacy and safety of oral solithromycin versus oral moxifloxacin for the treatment of community-acquired bacterial pneumonia: a global, double-blind, multi-centre, randomized, active-controlled, non-inferiority trial (SOLITAIRE-ORAL)" appears in the February 4th online issue and will be published in a future print issue of the journal.

PRINCETON, N.J., Feb. 04, 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 the underwriters of its previously announced public offering of common stock have exercised in full their option to purchase an additional 826,771 shares of Agile Therapeutics' common stock. The additional shares were sold at the public offering price of $6.35 per share before underwriting discounts and commissions. The closing occurred on February 4, 2016, bringing the total number of shares sold by Agile Therapeutics in the public offering to 6,338,583 and total gross proceeds to approximately $40.25 million. The total net proceeds after deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $37.3 million from the offering.

• Safe and well tolerated over two years
• Height velocity (HV) in second year comparable to published US rhGH daily dosing data; further confirms Phase 3 dose and schedule
• Extremely high rate of adherence to dosing schedule in Extension Study (18 months of at-home dosing)

MENLO PARK, Calif., Feb. 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 confirmatory two-year, top-line safety and efficacy data from its ongoing Extension Study of somavaratan in children with GHD.