Raptor Pharmaceutical Corp. (Nasdaq:RPTP) today that the FDA accepted its New Drug Application (“NDA”) for Cysteamine Bitartrate Delayed-release Capsules (RP103), for the potential treatment of nephropathic cystinosis. A standard 10-month review was issued. A PDUFA date was not issued but the company released a press release on March 30, 2012 that it had filed its NDA, meaning a PDUFA date of approximately January 30, 2013. It also said that it expects the European Medicines Agency to issue a decision during 1H 2013.
Aegerion Pharmaceuticals, Inc (Nasdaq:AEGR) announced that it intends to offer for sale its common stock in an underwritten public offering.