Highlights of weekly biotech stock moves
Regulatory, clinical and other milestones
Actelion Ltd. (SIX:ATLN) was down CHF1.34 to CHF44.99 on Friday after announcing FDA accepted for review an NDA for Opsumit macitentan to treat pulmonary arterial hypertension (PAH). A decision is expected around October 2013; the exact PDUFA date is not disclosed. Last week, the stock was down CHF1.81.
Alexza Pharmaceuticals Inc. (NASDAQ:ALXA) gained $0.60 (11%) to $5.84 on Friday after EMA's CHMP issued a positive opinion recommending Adasuve Staccato loxapine to treat mild to moderate agitation in adults with schizophrenia or bipolar disorder. The product is under FDA review with a Dec. 21 PDUFA date. Last week, the stock gained $0.65 (13%) to $5.84.
Algeta ASA (OSE:ALGETA) gained NOK0.60 to NOK160 last week after partner Bayer AG (Xetra:BAYN) submitted an MAA to EMA and an NDA to FDA for radium-223 dichloride (formerly Alpharadin) to treat castration-resistant prostate cancer (CRPC) in patients with bone metastases. The MAA submission triggered a €50 million ($64.5 million) milestone payment to Algeta.
Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) fell $4.95 (21%) to $18.93 on Friday after FDA granted accelerated approval to Iclusig ponatinib but included a boxed warning on leukemia drug. FDA approved the drug to treat resistant or intolerant chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL)