Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) and Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) mentioned that they expect the FDA may provide a tentative date within a month for an Advisory Committee meeting for its Supplemental New Drug Application (sNDA) for RELISTOR for opioid-induced constipation, or OIC, in patients with chronic pain. The FDA has stated that it will take action within 30 days after receiving input from the Advisory Committee.
Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio) announced that a registered direct placement of $15 million of common stock at the price of $3.35 per share plus an additional over-allotment warrant, exercisable within 12 months, to sell an additional $3.75 million of common stock at the same price which, if exercised, would result in gross proceeds of $18.75 million.
BioDelivery Sciences International, Inc. (NASDAQ: BDSI) remains on track to report data, expected in early 2014, from two pivotal Phase 3 studies of BEMA Buprenorphine for the treatment of chronic pain, in opioid naive and the other in opioid experienced patients. They also intend to initiate a Phase 2b trial of Clonidine Topical Gel for the treatment of painful diabetic neuropathy by the end of 2013.
Synergy Pharmaceuticals Inc. (Nasdaq:SGYP) provided a business update, noting that they expect to release data from their Phase 2b trial of plecanatide in patients with constipation-predominant irritable bowel syndrome (IBS-C), in 1Q 2014. A Phase 3 trial of plecanatide for the treatment of chronic idiopathic constipation (CIC) is expected to be initiated in 4Q 2013.
Omeros Corporation (NASDAQ: OMER) said that they plan to advance OMS824 into Phase 2 trials for Huntington’s disease and for schizophrenia later in 2013.
Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) noted that top-line data from their Phase 2 trial (HPV-003) focused on cervical dysplasia, will be reported in mid-2014.
Neuralstem, Inc. (NYSE MKT: CUR) announced that they expect to initiate their NSI-566 ALS Phase 2 trial in August or September, 2013. They also expect to initiate a Phase 1/2 trial of NSI-566 in patients with ischemic stroke, in Beijing, in August or September. This will take seven to eight months before the Phase 2 part of the trial is initiated. Data from their Phase 1b trial for major depressive disorder are due in 2H 2013.