Updated with three additional drug approval decision dates.
BOSTON (TheStreet) -- Here's your first look at the biotech and pharmaceutical companies with pending FDA drug approval decisions in 2012.
The calendar on the following pages captures nearly two-dozen U.S. regulatory events -- FDA drug approvals and advisory panels -- expected between December 2011 and July 2012. As every savvy biotech investor and trader knows, the volatility in biotech and drug stocks ramps significantly as U.S. regulators weigh whether to approve or reject new drugs.
Among the highlights from the 2012 FDA drug-approval calendar that should be of most interest to bio-pharma investors: A first-quarter FDA advisory panel that will once again tackle the thorny issue of obesity-drug safety, including Vivus' (VVUS) Qnexa; approval decisions for novel inhaled medicines from Alexza Pharmaceuticals (ALXA) and MAP Pharmaceuticals (MAPP); and the fifth (!!) attempt at approval for Discovery Labs' (DSCO) lung therapy for premature infants.Biotech and drug stocks below are listed in chronological order based on the closest regulatory catalyst. Affymax (AFFY)
Drug/indication:peginesatide for anemia in kidney dialysis patients.
FDA advisory panel: Dec. 7, 2011
Approval decision date:March 27, 2012
Peginesatide, injected once monthly, aims to compete against Amgen's (AMGN) Epogen ($2.5 billion in 2010 sales) as a treatment for anemia in patients with chronic kidney disease, although peginesatide use would be limited to sicker kidney dialysis patients only. Amgen recently signed long-term Epogen supply contracts with the two largest kidney dialysis clinics in the U.S. Pfizer (PFE)
Drug/indication:Inlyta (axitinib) for kidney cancer
FDA advisory panel: Dec. 7, 2011
Approval decision date: Feb-April 2012 Alexza Pharmaceuticals (ALXA)
Drug/indication:Adasuve for agitation related to schizophrenia
FDA advisory panel: Dec. 12, 2011
Approval decision date: Feb. 4, 2012
Adasuve uses Alexza's proprietary Staccato inhaler system to deliver the anti-agitation medicine loxapine directly into the lungs where it gets into the bloodstream and begins to work quickly. The FDA advisory panel is expected to focus much of its attention on the potential side effects and safety issues related to delivering Adasuve into patients' lungs. FDA initially rejected Adasuve in October 2010 due to concerns over lung safety. Alexza resubmitted the drug to FDA last August. Vivus (VVUS), Arena Pharmaceuticals (ARNA) and Orexigen Therapeutics (OREX)
Drugs/indication: Qnexa, lorcaserin and Contrave for obesity.
FDA advisory panel: First quarter 2012 (exact date not yet disclosed.)
FDA held advisory panels to review all three of these controversial weight-loss drugs in 2010. FDA subsequently rejected all three drugs. In 2012, Vivus and its obesity drug competitors are back for another shot, and FDA will once again bring together a group of outside experts to weigh the pros and cons of treating obesity with a pill.
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