Highlights of weekly biotech stock moves
Regulatory, clinical and other milestones
Affymax Inc. (NASDAQ:AFFY) lost $0.64 to $6.61 last week after FDA accepted for review an NDA for peginesatide (formerly Hematide) to treat anemia in chronic kidney disease (CKD) patients on dialysis. Affymax and partner Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) submitted the application in May, which would place the PDUFA date around March 2012. The companies did not disclose an actual date.
Alexza Pharmaceuticals Inc. (NASDAQ:ALXA) was off $0.25 (14%) to $1.53 last week after delaying its plans to resubmit an NDA for Staccato loxapine (AZ-004) to treat agitation in patients with schizophrenia or bipolar disorder. The company expects to resubmit on Aug. 8 instead of in July. The company, which received a complete response letter in October, expects a six-month review.
Amgen Inc. (NASDAQ:AMGN) gained $1.27 to $54.70 on Friday after providing several pipeline updates along with earnings. The biotech said it received complete response letters for two sBLAs for Vectibix