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December Catalysts for Drug and Biotech Stocks


The month is marked by important events for Pfizer, Regeneron, Affymax, BioSante and others.

December is full of holiday parties, shopping and market-moving drug news. The weeks leading up to Christmas include a number of significant events for drug and biotech stocks.

Some companies trying to win approval of their treatments face Food and Drug Administration panels, while others await word on clearance to sell their medicines. Investors will want to scrutinize study data being released, particularly research from a major blood disease conference in San Diego.

Some dates are subject to change.

December 7
Pfizer (PFE) faces an FDA advisory panel reviewing the drug Inlyta for advanced kidney cancer. It's important for Pfizer to bring new drugs to the market as it faces generic competition for Lipitor and other big-selling medicines. (This meeting also is of interest to investors in Aveo Pharmaceuticals (AVEO), which is developing its own kidney cancer treatment.)

Affymax (AFFY) goes before the same committee of advisers that afternoon for a review of the drug peginesatide for anemia caused by chronic kidney failure. This is a huge event for Affymax as a positive recommendation would give hope that the company may win approval for its first drug. However, there are safety concerns. Last year, the company's stock plunged after study data showed heart risks associated with taking the medicine. The FDA is very cautious about approving drugs that carry safety risks. If OK'd, the drug would compete with Amgen's (AMGN) Epogen and Aranesp, which have known safety issues as well.

December 8
Antares Pharma (AIS) expects word from the FDA on possible approval of Anturol Gel, for overactive bladder. Antares is known for its drug-injection technology, including needle-free devices. The gel isn't a make-or-break product but the FDA decision should have a bearing on the stock.

December 10
A number of companies will be presenting their research at the annual meeting of the American Society of Hematology in San Diego, December 10-13. Celgene (CELG), Micromet (MITI), Onyx Pharmaceuticals (ONXX), Seattle Genetics (SGEN) and YM Biosciences (YMI) are among the many companies making presentations.

December 12
Alexza Pharmaceuticals (ALXA) resubmitted its drug Adasuve for agitation in patients with schizophrenia or bipolar disorder in August. A panel of expert government advisers meets to review the drug after the FDA rejected because of safety concerns about respiratory side effects. The FDA is expected to decide on the drug's approval by early February.

Also in December:
Regeneron (REGN) is expected to release data from two years of studying its drug Eylea, which treats a disease that causes blindness in the elderly. If the data suggests that Regeneron's drug is more effective than Roche's Lucentis, it could signal a competitive advantage. (See What's Next for Regeneron?)

BioSante (BPAX) is expected to release top-line data from studies testings its LibiGel for women with low sexual drives. BioSante's testosterone gel is being tested to show effectiveness. The company also is conducting a large safety study and results of that research should be released in third quarter next year.

Twitter: @brettchase

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No positions in stocks mentioned.
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