Highlights of weekly biotech stock moves
Regulatory, clinical and other milestones
Adventrx Pharmaceuticals Inc. (NYSE-A:ANX) was off $1.48 (58%) to $1.06 on Wednesday after receiving a complete response letter from FDA for an NDA for Exelbine vinorelbine injectable emulsion to treat non-small cell lung cancer (NSCLC). According to the company, FDA said the authenticity of the drug products used in Adventrx's bioequivalence trial could not be verified following inspections at clinical sites. The agency said the trial will need to be repeated. Adventrx lost $1.40 (57%) to $1.06 for the week.
Affymax Inc. (NASDAQ:AFFY) fell $0.68 (13%) to $4.51 last week, when FDA set a March 27, 2012, PDUFA date for an NDA for peginesatide to treat anemia in chronic kidney disease (CKD) patients on dialysis. Affymax also received a $10 million milestone from partner Takeda Pharmaceutical Co. Ltd. (Tokyo:4502). The milestone was triggered by FDA's acceptance of the NDA, which Affymax announced last month...