Highlights of weekly biotech stock moves
Regulatory, clinical and other milestones
Columbia Laboratories Inc. (NASDAQ:CBRX) was off $0.09 to $3.14 last week after FDA accepted for review an NDA for Prochieve vaginal progesterone gel to reduce the risk of preterm birth in women with short urterine cervical length in the mid-trimester of pregnancy. The PDUFA date is Feb. 26, 2012. The filing triggers a $5 million payment to Columbia from partner Watson Pharmaceuticals Inc. (NYSE:WPI).
Corcept Therapeutics Inc. (NASDAQ:CORT) lost $0.71 (15%) to $3.91 last week after FDA accepted for review an NDA for Corlux mifepristone to treat Cushing's syndrome. The PDUFA date is Feb. 17, 2012. Corcept had originally requested Priority Review, which could have meant an FDA action date as early as October.
Dendreon Corp. (NASDAQ:DNDN) rose $2.75 to $41.40 last week after the CMS issued a National Coverage Determination that requires Medicare to reimburse for prostate cancer therapy Provenge sipuleucel-T for its FDA-approved indication. Dendreon said it has not provided updated guidance. In May, Dendreon said it expected 2011 revenue of $350-$400 million.(see B14).
Separately, FDA approved a license for Dendreon's Los