BioCentury
ARTICLE | Finance

Highlights of weekly biotech stock moves

Regulatory, clinical and other milestones

February 13, 2012 8:00 AM UTC

Amgen Inc. (NASDAQ:AMGN) was off $1.92 to $67.36 last week after FDA's Oncologic Drugs Advisory Committee voted 12-1 on Wednesday that Xgeva denosumab does not have a favorable benefit-risk profile to prevent bone metastases in men with castration-resistant prostate cancer (CRPC). Xgeva is already marketed to prevent skeletal related events in adults with bone metastases from solid tumors (see "Waiting for Xgeva," A8).

Astex Pharmaceuticals Inc. (NASDAQ:ASTX) lost $0.60 (22%) to $2.19 on Tuesday after FDA reviewers said a Phase III study of Dacogen decitabine failed to demonstrate a benefit in elderly patients with acute myelogenous leukemia. The comments came in briefing documents released ahead of Thursday's meeting of the Oncologic Drugs Advisory Committee, which voted 10-3 against Dacogen, with one abstention. The sNDA, submitted by partner Eisai Co. Ltd. (Tokyo:4523; Osaka:4523), has a March 6 PDUFA date. Dacogen is approved to treat myelodysplastic syndromes (MDS)...