News

ANN ARBOR, MI --(Marketwired - February 02, 2015) - Esperion Therapeutics, Inc. (NASDAQ: ESPR), an emerging pharmaceutical company focused on developing and commercializing first-in-class, oral, low-density lipoprotein cholesterol (LDL-cholesterol) lowering therapies for the treatment of hypercholesterolemia and other cardio-metabolic risk markers, today announced the U.S. Food and Drug Administration (FDA) has removed the peroxisome proliferator-activated receptor (PPAR) partial clinical hold on ETC-1002. The action by the FDA will now allow Esperion to conduct clinical trials exceeding six months in duration.

New Treatment Parameters Provide Significant Time Savings with Same Patient Outcomes Company Will Launch New CoolSmooth PRO™ Applicator in Conjunction with This Clearance PLEASANTON, Calif.--(BUSINESS WIRE)-- ZELTIQ® Aesthetics, Inc. (NASDAQ: ZLTQ), a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology platform, today announced that it has received Food and Drug Administration (FDA) clearance to perform the CoolSculpting® procedure at lower temperatures, which will enable shorter treatment times. In conjunction with this clearance, ZELTIQ will be introducing a brand new applicator, CoolSmooth PRO™, which is a second generation surface applicator that features non-vacuum based cooling to treat non-pinchable fat bulges, such as the outer thigh area.

MENLO PARK, Calif., Jan. 21, 2015 (GLOBE NEWSWIRE) -- Versartis, Inc. (Nasdaq:VSAR), an endocrine-focused biopharmaceutical company, today announced the pricing of an underwritten public offering of 4,347,826 shares of its common stock at a price to the public of $17.25 per share. In addition, Versartis has granted the underwriters a 30-day option to purchase up to 652,173 additional shares of common stock. The offering is expected to close on January 27, 2015, subject to customary closing conditions.

PRINCETON, New Jersey, Jan. 20, 2015 (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, announced today that it has entered into a definitive stock purchase agreement with a group of institutional accredited investors, including both existing and new investors, for the private placement of approximately 3.4 million shares of common stock at $5.85 per share yielding expected gross proceeds of $20.0 million. The price per share represents the market value of the Company's common stock as defined by Nasdaq as of January 16, 2015. The private placement is expected to close on or about January 23, 2015, subject to customary closing conditions.

MORRISTOWN, NJ – (BUSINESS WIRE) – January 15, 2015 – Pernix Therapeutics Holdings, Inc. (NASDAQ: PTX) today announced that its supplemental New Drug Application (sNDA) for TREXIMET (sumatriptan / naproxen sodium) has been accepted by the U.S. Food and Drug Administration (FDA). Approval is expected in 2Q 2015, based on the anticipated Prescription Drug User Fee Act (PDUFA) action date.

CHAPEL HILL, N.C., Jan. 13, 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 it has completed its previously announced underwritten public offering of 5,250,000 shares of common stock, plus an additional 787,500 shares issued pursuant to the full exercise by the underwriters of their option to purchase additional shares at a public offering price of $24.50 per share. The full exercise of the option increases the net proceeds to the company, after underwriting discounts and commissions and expected expenses of the offering expenses, from approximately $120.6 million to approximately $138.7 million. The company intends to use the net proceeds from the offering to fund its research and development activities, including continued clinical and regulatory development of solithromycin in community acquired bacterial pneumonia (CABP) and gonorrhea and Taksta™ in bone and joint infections, preparation for commercial readiness for solithromycin in CABP, working capital and general corporate and administrative expenses.

- Opportunity to pursue multiple additional indications for brincidofovir DURHAM, N.C., Jan. 12, 2015 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that the United States Patent and Trademark Office has issued a Notice of Allowance for a patent application covering a method of synthesis and the commercial morphic form of brincidofovir. With the addition of this most recent patent, composition of matter coverage for brincidofovir in the U.S. is expected to extend to October 2034.

The VELOCITY Study Begins for Long-Acting Recombinant Human Growth Hormone in GHD Pediatric Patients MENLO PARK, Calif., Jan. 8, 2015 (GLOBE NEWSWIRE) -- Versartis, Inc. (Nasdaq:VSAR), an endocrine-focused biopharmaceutical company that is developing a novel, long-acting form of recombinant human growth hormone (rhGH), today announced the initiation of its Phase 3 study of VRS-317 for semi-monthly dosing in children with growth hormone deficiency (GHD). This registration trial follows positive data from the Company's completed Phase 1b/2a VERTICAL study and the ongoing long-term Extension Study.

Phase 3 program aims to address patient need for alternative treatment options in moderate-to-severe psoriasis Program includes the first Phase 3 study in psoriasis comparing two anti-TNFs Based on current enrollment projections, top-line data from these studies are expected in 2017 MENLO PARK, Calif., and BRUSSELS, Belgium, Jan. 8, 2015 (GLOBE NEWSWIRE) -- Dermira, Inc., a specialty biopharmaceutical company focused on bringing innovative and differentiated medical dermatology products to dermatologists and their patients (Nasdaq:DERM), and UCB, a global biopharmaceutical leader (Euronext:UCB), announced today that the first patients have been dosed in the Phase 3 clinical program designed to evaluate the efficacy and safety of CIMZIA® (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis. This is an important step forward in the collaboration between Dermira and UCB in the development of solutions for patients with moderate-to-severe plaque psoriasis, a severe autoimmune disease.1 CIMZIA® is not currently approved for the treatment of psoriasis by any regulatory authority worldwide.

BOSTON, Jan. 6, 2015 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) today announced Actavis will be making a $4 million milestone payment to Paratek under the terms of the parties' collaboration for the development of sarecycline (WC3035). Under the collaboration, Actavis has initiated Phase 3 clinical trials of sarecycline in moderate to severe acne. Paratek will be entitled to additional payments upon the achievement of regulatory and commercialization milestones, including the FDA's acceptance of a new drug application (NDA) from Actavis, FDA approval and royalties on future sales.