BioCentury
ARTICLE | Finance

Highlights of weekly biotech stock moves

Regulatory, clinical and other milestones

February 18, 2013 8:00 AM UTC

Algeta ASA (OSE:ALGETA) gained NOK5.10 to NOK183.90 last week after partner Bayer AG (Xetra:BAYN) said FDA accepted and granted Priority Review to an NDA for radium-223 dichloride (formerly Alpharadin) to treat castration-resistant prostate cancer (CRPC) in patients with bone metastases. An eight-month Priority Review would place the PDUFA date in August; the specific date is not disclosed. Bayer submitted an MAA to EMA in December.

Cangene Corp. (TSX:CNJ) was up C$0.37 (14%) to C$3.07 last week after FDA's Blood Products Advisory Committee unanimously recommended approval of botulism antitoxin heptavalent (BAT) to treat botulism. The BLA is under Priority Review with a March 22 PDUFA date. Cangene is seeking approval under FDA's animal rule, which allows for marketing approval to be granted based on efficacy in relevant animal models and an acceptable safety risk profile in humans...