News

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.

CHAPEL HILL, N.C. and WATERTOWN, Mass., Feb. 01, 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, and Macrolide Pharmaceuticals, Inc., a preclinical company focused on the development of novel macrolide antibacterials, today announced an agreement where Macrolide will use its novel, proprietary synthesis technology to provide Cempra with a fully synthetic process for its late-stage investigational macrolide antibiotic, solithromycin. Solithromycin has completed Phase 3 clinical trials and a New Drug Application (NDA) is in progress for the treatment of community acquired bacterial pneumonia. Solithromycin is currently manufactured using clarithromycin, a fermentation-derived antibiotic, as the starting material. Based on ground-breaking technology developed by Andrew G. Myers, Ph.D., and colleagues at Harvard University, Macrolide Pharmaceuticals will partner with Cempra with the goal of developing a fully synthetic, cost-competitive manufacturing process for solithromycin. An alternative fully synthetic process could provide manufacturing and supplier flexibility by reducing dependence upon fermentation-derived starting materials.

NEW YORK-- Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced the company has filed with the U.S. Food and Drug Administration (FDA) its first new drug application (NDA) for plecanatide in chronic idiopathic constipation (CIC).

PRINCETON, N.J., Jan. 22, 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 the pricing of its underwritten public offering of 5,511,812 shares of its common stock at a public offering price of $6.35 per share. The gross proceeds from the offering, before deducting the underwriting discounts and commissions and estimated offering expenses payable by Agile Therapeutics, are expected to be approximately $35 million. In addition, Agile Therapeutics granted the underwriters a 30-day option to purchase up to 826,771 additional shares of common stock at the public offering price, less the underwriting discounts and commissions. All shares in the offering will be sold by Agile Therapeutics.

MENLO PARK, Calif. (KGO) -- If you enjoy all the live performances in the Bay Area, you are no doubt grateful for the gift of sound. One Bay Area company is hoping to restore that gift to thousands of people who experience hearing loss.

STAMFORD, Conn., Jan. 15, 2016 (GLOBE NEWSWIRE) -- Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced that the European Medicines Agency (EMA) has granted the company orphan drug designation for LOXO-101 for treatment of patients with soft tissue sarcoma. Soft tissue sarcomas are cancers of the body's connective or supportive tissues, such as cartilage, fat, muscle, fibrous tissue, and blood vessels. The EMA grants orphan drug designation to support the development of medicines for underserved patient populations, or rare disorders, that affect no more than five in 10,000 individuals in the European Union (EU). Orphan drug designation provides to Loxo certain benefits, including protocol assistance, reduced fees for regulatory activities and up to ten years of market exclusivity in the EU upon marketing approval for the designated indication.

— Company to Provide Details of Phase 3 Global Development Strategy in Q2 2016 — ANN ARBOR, Mich., Jan. 13, 2016 (GLOBE NEWSWIRE) -- Esperion Therapeutics, Inc. (NASDAQ:ESPR), a pharmaceutical company focused on developing and commercializing first-in-class, oral, low-density lipoprotein cholesterol (LDL-C) lowering therapies for the treatment of patients with hypercholesterolemia, today announced the start of a global Phase 3 long-term safety and tolerability study (ETC-1002-040) of bempedoic acid in patients with hyperlipidemia whose LDL-C is not adequately controlled with low- and moderate-dose statins. This study will enable the Company to understand the 52 week safety profile of bempedoic acid, and top-line results are expected in the fourth quarter of 2017.

– Company Advancing Pipeline of Clinical and Preclinical Product Candidates and Proprietary Gene Control Platform – CAMBRIDGE, Mass.--(BUSINESS WIRE)--Syros Pharmaceuticals today announced the closing of a $40 million financing of preferred stock. New investor Deerfield Management Company led the financing, which also included participation from new investor Casdin Capital as well as existing investors Fidelity Management and Research Company, WuXi Healthcare Ventures, Polaris Partners, Redmile Group, Aisling Capital and Alexandria Venture Investments.

ANN ARBOR, Mich., Jan. 12, 2016 (GLOBE NEWSWIRE) -- Esperion Therapeutics, Inc. (NASDAQ:ESPR), a pharmaceutical company focused on developing and commercializing first-in-class, oral, low-density lipoprotein cholesterol (LDL-C) lowering therapies for the treatment of patients with hypercholesterolemia, today announced initiation of its Phase 2 pharmacokinetics/pharmacodynamics (PK/PD) study (ETC-1002-035) of bempedoic acid in patients treated with atorvastatin 80 mg, the most commonly prescribed high-dose statin. The Company expects to announce top-line results from the study by mid-year.