APPA to file NDA this September. LGND PDUFA set for November. FLML NDA due this year. XNPT offering + CYTR
A.P. Pharma, Inc. (OTCBB: APPA.OB) announced that it now hopes to re-file its NDA of APF530, for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting, during September 2012. The company had previously given guidance of a filing during “mid-2012”. The company also said it has issued 102m shares at $0.525 per share, resulting in gross proceeds of approximately $53.6 million.
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced that its partner GlaxoSmithKline (NYSE: GSK) has been granted priority review from the FDA for the supplemental new drug application for Promacta to treat thrombocytopenia in adult patients with chronic hepatitis C virus (HCV) infection. A press release from GSK was released on May 30, 2012, regarding the sNDA filing, resulting in a PDUFA date of on or about November 30, 2012, under a 6-month priority review.
Flamel Technologies (NASDAQ: FLML) today said it remains on track to file its first NDA during 2012.
CytRx Corporation (NASDAQ: CYTR) announced the initiation of a Phase 1b clinical trial of aldoxorubicin (formerly INNO-206) administered in combination with the commonly used chemotherapeutic agent doxorubicin in patients with advanced solid tumors who have failed other therapies.
XenoPort, Inc. (Nasdaq:XNPT) announced the pricing of an underwritten offering of 6,153,846 shares of its common stock at a price to the public of $6.50 per share, for gross proceeds of $40m.