THR/TBGNF positive Adcom vote. AMRN and HZNP FDA Approval. SCMP files sNDA. SNTA offering. EXEL initiates Phase 2 NSCLC trial.AEZS update.
ThromboGenics NV (Euronext Brussels: THR) (PINK:TBGNF) – The FDA Dermatologic and Ophthalmic Drugs Advisory Committee recommended that ocriplasmin be granted approval for the treatment of symptomatic Vitreomacular Adhesion (VMA) by a vote of 10 to 0. The PDUFA date is 17 October, 2012.
Amarin Corporation plc (Nasdaq:AMRN) announced the FDA has approved Vascepa capsules (AMR101) as a treatment to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. The company expects a commercial launch of Vascepa early in 1Q 2013, and will consider three potential paths for the marketing and sale of the product: an acquisition of Amarin, a strategic collaboration, or self-commercialization, the latter of which could include third-party support.
Horizon Pharma, Inc., (NASDAQ: HZNP) announced the FDA has approved RAYOS (prednisone) delayed-release tablets (1 mg, 2 mg and 5 mg) to treat a broad range of diseases including rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma and chronic obstructive pulmonary disease (COPD).
Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) and Takeda Pharmaceuticals U.S.A. Inc. (TPUSA) announced the filing of a supplemental new drug application (sNDA) for a new indication for AMITIZA (lubiprostone) for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain.
Exelixis, Inc. (NASDAQ:EXEL) announced the initiation of a Phase 2 trial of cabozantinib in non-small cell lung cancer (NSCLC) patients who have tested positive for gene fusions that activate RET.
Synta Pharmaceuticals Corp. (NASDAQ: SNTA) announced a registered direct offering of 3,976,702 shares of its common stock at a price of $6.49 per share, for gross proceeds of approximately $25.8 million.
Aeterna Zentaris Inc. (NASDAQ: AEZS) gave an update maintaining previous guidance that it intends to initiate a pivotal trial of AEZS-108 in endometrial cancer by the end of 2012.