CRTX Advisory Committee date set. MAPP Levadex NDA update. ZGNX offering + updates for ITMN MDVN AEZS DVAX NKTR CADX
Cornerstone Therapeutics, Inc. (NASDAQ:CRTX) – The Cardiovascular and Renal Drugs Advisory Committee will meet on September 13, 2012, to discuss the NDA of lixivaptan, for the proposed indication of the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone (SIADH), respectively.
MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) said it hopes to resubmit its NDA of LEVADEX for the treatment of migraine, in late 3Q / early 4Q 2012.
InterMune, Inc. (NASDAQ: ITMN) continues to expect that its Phase 3 pirfenidone study, ASCEND, will be fully enrolled around the end of 2012, and that results from the study will be available in 1H 2014.
Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (TSE: 4503) announced that the FDA has accepted the New Drug Application (NDA) for enzalutamide (formerly MDV3100) for the potential treatment of men with castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy and granted Priority Review Designation, resulting in a PDUFA date on or about November 21, 2012.
Aeterna Zentaris Inc. (NASDAQ: AEZS) announced that it has filed a request with the FDA for Fast Track designation for its oral ghrelin agonist, AEZS-130, as a diagnostic test for adult growth hormone deficiency (AGHD). If the company obtains Fast Track designation, it hopes to submit its NDA on a rolling basis and complete the NDA submission in1Q 2013.
Dynavax Technologies Corporation (NASDAQ: DVAX) announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) pursuing an indication for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age and in patients with chronic kidney disease.
Nektar Therapeutics (NASDAQ: NKTR) announced that it has initiated a Phase 2 trial of NKTR-181 in patients with moderate to severe chronic pain from osteoarthritis of the knee. Approximately 200 patients will be randomized to receive either NKTR-181 or placebo in the trial.
Cadence Pharmaceuticals, Inc. (NASDAQ:CADX) said in a SEC Filing that it has initiated a voluntary recall of certain lots of OFIRMEV (acetaminophen) injection due to the presence of unidentified visible particles in a limited number of vials from one lot, which were detected during routine stability testing. No supply shortages are anticipated as a result of this action, as Cadence continues to distribute product from its alternate supplier.
Zogenix Inc. (Nasdaq:ZGNX) priced its underwritten public offering of 32,500,000 units at $2 per unit. Each unit consists of one share of common stock and a warrant to purchase 0.45 of a share of common stock. Net proceeds will be approximately $60.7 million.