Regulatory milestones

Acura Pharmaceuticals Inc. (NASDAQ:ACUR) lost $0.11 to $3.57 last week after the company and partner King Pharmaceuticals Inc. (NYSE:KG) announced plans to submit an NDA early next year for Acurox oxycodone without niacin. Last month an FDA panel voted against approval of Acurox with niacin due in part to concerns about niacin's ability to sufficiently deter abuse (see B9).

Amylin Pharmaceuticals Inc. (NASDAQ:AMLN) lost $3.58 (17%) to $17.06 last week after FDA accepted the company's response to a March complete response letter for an NDA for Bydureon exenatide once weekly to treat Type II diabetes. The agency designated the response a Class 2 resubmission and set an Oct. 22 PDUFA date...