HEB to resubmit Ampligen NDA 3Q 2012. IMGN offering. OREX cardio trial update. TSPT receives aNDA notification + HGSI QLTI updates
Hemispherx Biopharma, Inc. (NYSE MKT: HEB) said that it plans to resubmit its New Drug Application (NDA) of Ampligen for the treatment of Chronic Fatigue Syndrome (CFS), in 3Q 2012. This is in response to a Complete Response Letter (CRL) issued by the FDA in 2009. The FDA has advised that, once submitted, the complete response will be on a six month review cycle. A FDA Advisory Committee meeting is also likely to be scheduled according to the company.
Orexigen Therapeutics, Inc. (Nasdaq: OREX) today announced an update to the projected timeframe for completion of enrollment of the Light Study, the Contrave cardiovascular outcomes clinical trial. Orexigen now expects to complete enrollment of patients required for the interim analysis of the Light Study in the first quarter of 2013. After approximately 87 major adverse cardiovascular events (MACE) have been adjudicated, Orexigen will conduct an interim analysis.
GlaxoSmithKline (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) announced that data have been received from the Phase 3 Harmony 8 study of albiglutide in patients with in type 2 diabetes. GSK intends to file a NDA in 2013. HGSI is entitled to fees and milestone payments that could amount to as much as $183 million – including $33.0 million received to date – in addition to single-digit net royalties on worldwide sales if albiglutide is commercialized.
Transcept Pharmaceuticals, Inc. (NASDAQ:TSPT) said in a SEC filing that an Abbreviated New Drug Application for a generic version of Intermezzo (zolpidem tartrate) sublingual tablet C-IV was submitted on April 10, 2012. The company has not yet received a Paragraph IV certification with respect to this filing.
QLT Inc. (NASDAQ: QLTI; TSX: QLT) announced earlier in the week that it will reduce its workforce by 146 employees to 68 and will focus its efforts on the development of its Synthetic Oral Retinoid program, QLT091001, in critical orphan indications. The first two indications for this program are Leber Congenital Amaurosis (LCA) and Retinitis Pigmentosa (RP). QLT hopes to be in pivotal clinical trials for LCA no later than 1Q 2013 and for RP no later than the end of 2Q 2013.
ImmunoGen, Inc. (Nasdaq: IMGN) announced that it intends to offer for sale its common stock in an underwritten public offering.