ZGNX PDUFA date confirmed. PATH resubmits NDA for migraine. HGSI to be acquired by GSK + MDGN RPRX updates
Zogenix, Inc. (Nasdaq:ZGNX) announced that the FDA has set a PDUFA date of March 1, 2013 for the Zohydro ER New Drug Application (NDA), for the treatment of moderate to severe chronic pain.
NuPathe Inc. (NASDAQ: PATH) announced that it has resubmitted its NDA for its migraine patch (NP101), with a likely six-month review period by the FDA.
GlaxoSmithKline plc (LSE: GSK) and Human Genome Sciences (NASDAQ: HGSI) announced that they have entered into a definitive agreement under which GSK will acquire HGS for US$14.25 per share in cash.
Repros Therapeutics Inc. (NASDAQ: RPRX) announced that the FDA intends to update the full clinical hold to a partial clinical hold of oral Proellex as a treatment for endometriosis, as soon as they have reached agreement on the design of a Phase 2 study protocol. Repros plans to submit the study protocol to the FDA in the next several days.
Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG) said it has initiated a Phase 2a clinical trial in Israel of EPODURE Biopumps to treat anemia in patients with end-stage renal disease on dialysis.