News

MENLO PARK, Calif., February 5, 2015 – Dermira, Inc. (NASDAQ: DERM), a specialty biopharmaceutical company focused on bringing innovative and differentiated products to dermatologists and their patients, today announced positive Phase 2b study results for DRM04, its proprietary topical anticholinergic product, in patients with axillary hyperhidrosis, or excessive underarm sweating. Based on the results of this study (DRM04-HH02) and its first Phase 2b study (DRM04-HH01), Dermira plans to initiate a Phase 3 program for DRM04 in axillary hyperhidrosis in the second half of 2015, consistent with previous expectations and subject to an end-of-phase 2 meeting with the U.S. Food and Drug Administration (FDA).

LEXINGTON, Mass., Feb. 3, 2015 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (Nasdaq:TTOO) a company developing innovative diagnostic products to improve patient health today announced that the company has entered into a multi-year, strategic agreement with Canon U.S. Life Sciences, Inc. to jointly develop a novel diagnostic test panel to rapidly detect Lyme disease, a tick-borne bacterial infection that, if left untreated, can cause chronic joint inflammation, neurological disorders and cognitive defects.

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.