BioCentury
ARTICLE | Finance

Highlights of weekly biotech stock moves

Regulatory, clinical and other milestones

August 8, 2011 7:00 AM UTC

Alexza Pharmaceuticals Inc. (NASDAQ:ALXA) was off $0.08 to $1.32 on Friday after resubmitting an NDA to FDA for Staccato loxapine (AZ-004) to treat agitation in patients with schizophrenia or bipolar disorder. Alexza expects the agency to designate the NDA a Class 2 resubmission, with a six-month review. Last October, FDA issued a complete response letter for the product. Alexza lost $0.21 (14%) for the week.

Incyte Corp. (NASDAQ:INCY) was off $3.14 (18%) to $14.30 last week when FDA accepted and granted Priority Review to an NDA for ruxolitinib to treat myelofibrosis. The PDUFA date is Dec. 3. An MAA from Novartis AG (NYSE:NVS; SIX:NOVN), which has ex-U.S. rights, is under review in the EU...