Highlights of weekly biotech stock moves
Regulatory, clinical and other milestones
Regulatory milestones
Arena Pharmaceuticals Inc. (NASDAQ:ARNA) jumped $2.54 (29%) to $11.39 on Wednesday after FDA approved an NDA for Belviq lorcaserin for chronic weight management. The approval triggered a $20 million milestone payment from marketing partner Eisai Co. Ltd. (Tokyo:4523; Osaka:4523). But the gains didn't last long; for the week, Arena was up $0.10 to $9.98(see B10).
Fellow obesity companies Orexigen Therapeutics Inc. (NASDAQ:OREX) and Vivus Inc. (NASDAQ:VVUS) also rose on the news. Orexigen gained $1.47 (36%) to $5.54 on the week, while Vivus was up $2.03 to $28.54. The latter has a July 17 PDUFA date for its Qnexa phentermine/topiramate.
Dynavax Technologies Corp. (NASDAQ:DVAX) gained $0.07 to $4.32 last week after FDA accepted for review a BLA for Heplisav to prevent HBV infection. FDA will review the application under a 10-month Standard Review, with a PDUFA date of Feb. 24, 2013. Dynavax had requested Priority Review, which would have resulted in a six-month review. The company plans to submit an MAA to EMA next quarter.
Gilead Sciences Inc. (NASDAQ:GILD) gained $0.76 to $51.28 last week after submitting a pair of NDAs to FDA for elvitegravir to treat HIV-1
