News

San Diego, CA – September 22, 2014 – Cidara Therapeutics, a privately held biopharmaceutical company, today announced that it has been named by FierceBiotech as one of 2014’s Fierce 15 biotechnology companies, designating it as one of the most promising private biotechnology companies in the industry.

PRINCETON, N.J., Sept. 16, 2014 (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 the initiation of its Phase 3 study called SECURE (Study to Evaluate Contraceptive Use, Reliability and Effectiveness). The SECURE study is designed to assess the efficacy, safety and tolerability of Agile's investigational once-weekly transdermal contraceptive patch, Twirla™ (AG200-15). Twirla will be the only low-dose combined hormonal contraceptive patch and delivers the active ingredients ethinyl estradiol and levonorgestrel, both of which have an established history of efficacy and safety in currently marketed combination low-dose oral contraceptives.

MENLO PARK, Calif.--Intersect ENT, Inc. (Nasdaq:XENT), a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, today announced the enrollment of the first patient in PROGRESS, a prospective, randomized, blinded, multi-center trial to assess the safety and efficacy of the PROPEL® mini steroid eluting sinus implant to treat patients with frontal sinusitis.

Includes: United States, Europe and South Korea RAMSEY, N.J.-- ADMA Biologics, Inc. (OTCQB:ADMA), a late-stage biopharmaceutical company that develops, manufactures, and intends to market specialty plasma-based biologics for the treatment and prevention of certain infectious diseases, today announced that its wholly owned subsidiary, ADMA BioCenters in Norcross, Georgia, received approval from the Korean Ministry of Food and Drug Safety (MFDS) for the sale of source plasma into South Korea.

Toyama Receives Regulatory Clearance to Begin Phase 2 Trial Following Completion of Successful Phase 1 Study in Japan CHAPEL HILL, N.C., Sept. 9, 2014 (GLOBE NEWSWIRE) -- Cempra, Inc. (Nasdaq:CEMP) today announced the receipt of a $10 million milestone payment from Toyama Chemical Co., a subsidiary of FUJIFILM Holdings Corporation, triggered by Toyama's progress of its solithromycin clinical development program in Japan, the world's second largest antibiotic market. The payment was made following Toyama's receipt of regulatory clearance to begin a Phase 2 trial of solithromycin in Japan following successful completion of a Phase 1 study.

-- First-Line Use of Brincidofovir for CMV May Preserve Subsequent Therapeutic Options -- -- Data Presented at 2014 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) -- DURHAM, N.C., Sept. 8, 2014 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, announced new data today that suggests a potentially favorable resistance profile for brincidofovir for the treatment of life-threatening adenovirus and the prevention and treatment of cytomegalovirus (CMV). Results of the in vitro (cell culture) and Phase 2 studies were presented at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington, D.C.

STAMFORD, Conn., Sept. 4, 2014 (GLOBE NEWSWIRE) -- Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company focused on developing targeted cancer therapies for genetically-defined populations, today announced the closing of the initial public offering of 5,903,538 shares of its common stock, including 642,000 shares of common stock that were issued upon the exercise of the underwriters' over-allotment option to purchase additional shares, at a price to the public of $13.00 per share. The initial closing of 5,261,538 shares of common stock occurred on August 6, 2014. Concurrently with the initial closing, Loxo Oncology also sold through a private placement 230,769 shares of its common stock to New Enterprise Associates 14, L.P., an existing stockholder, at the initial public offering price.

$17.0 Million Awarded in Latest Contract Extension DURHAM, N.C., Sept. 2, 2014 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals, today announced an award of $17.0 million through the extension of its contract with the Biomedical Advanced Research and Development Authority (BARDA) for the development of its broad spectrum antiviral brincidofovir (BCV, CMX001) as a medical countermeasure to treat smallpox. Chimerix received the initial award in February 2011 which supported early research and development of brincidofovir in animal models of smallpox (Contract Number HHSO100201100013C). This contract extension provides an additional $17.0 million to Chimerix for a period of 15 months, and will support Phase 3 trials expected to initiate in the second half of 2014.

With the recent acquisition of Seragon, Genentech is excited to add a new class of investigational medicines known as SERDs to our pipeline. This potential new treatment option for breast cancer could eliminate estrogen receptors from cells and potentially redefine the standard of care for hormone receptor positive cancer, one of the most common types of cancer in women.

MORRISTOWN, NJ, August 20, 2014 – Pernix Therapeutics Holdings, Inc. (NASDAQ GM: PTX) (“Pernix” or the “Company”), a specialty pharmaceutical company, announced today that it has closed its acquisition of Treximet® (sumatriptan / naproxen sodium) for the acute treatment of migraine attacks with or without aura in adults. Pernix first announced its agreement with GlaxoSmithKline (NYSE: GSK) to acquire the U.S rights to Treximet® on May 14. Pernix’s expanded team of approximately 100 specialty sales professionals will support the sales and marketing of Treximet®. The Company will hold a conference call on Wednesday, August 20 at 9:00 a.m. EDT to discuss this acquisition.