Highlights of weekly biotech stock moves
Regulatory, clinical and other milestones
Celgene Corp. (NASDAQ:CELG) was up $0.70 to $78.42 on Friday after FDA approved an sNDA for Abraxane nab-paclitaxel for first-line treatment of advanced non-small cell lung cancer (NSCLC). The product was first approved in the U.S. in 2005 to treat metastatic breast cancer.
Earlier in the week, EMA's CHMP reiterated that it needs mature overall survival data before it can make a decision on whether to approve an expanded label for multiple myeloma (MM) drug Revlimid lenalidomide (see B13).
Overall, Celgene lost $1.87 for the week.
Impax Laboratories Inc. (NASDAQ:IPXL) gained $0.30 to $26.35 on Friday after FDA extended the PDUFA date by three months for an NDA for Rytary extended-release carbidopa/levodopa (IPX066) to treat idiopathic Parkinson's disease (PD). The new date is Jan. 21; it was Oct. 21.
According to Impax, FDA needs more time to review information on the excipient that the company submitted at the agency's request. FDA considered the submission to be a major amendment. The NDA was submitted under section 505(b)(2) of the Food, Drug and Cosmetic