BioCentury
ARTICLE | Finance

Highlights of weekly biotech stock moves

Regulatory, clinical and other milestones

September 3, 2012 7:00 AM UTC

Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) gained $0.20 to $20.56 last week after submitting an MAA to EMA for ponatinib to treat resistant or intolerant chronic myelogenous leukemia (CML) and Philadelphia-chromosome positive (Ph+) acute lymphoblastic leukemia (ALL). EMA's CHMP granted the company's request for accelerated assessment, which will shorten the review to 150 days from 210. In July, Ariad began submission of a rolling NDA to FDA.

BTG plc (LSE:BTG) was off 16.50p to 302.20p last week after FDA accepted and granted Priority Review to an sNDA from Johnson & Johnson (NYSE:JNJ) for Zytiga abiraterone in combination with prednisone to treat patients with metastatic castration-resistant prostate cancer who are asymptomatic or mildly asymptomatic after failing androgen deprivation therapy. The PDUFA date isn't disclosed; a six-month Priority Review would place the date in mid-December. J&J has rights from BTG...