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November Catalysts for Biotech and Drug Stocks


Regeneron, Alimera Sciences, Transcept Pharmaceuticals all await FDA decisions on experimental drugs.

There's a full calendar of events for biotech and drug company investors in November. The month begins with a trio of scientific meetings and there are several US Food and Drug Administration sales approval decisions expected.

Here's a rundown of some highlights. As always, dates are subject to change.

November 3
Vertex Pharmaceuticals (VRTX) will highlight nine studies, including late-stage drug trial data at the North American Cystic Fibrosis Conference in Anaheim, California. The conference runs through November 5.

November 4
Vertex, Pharmasset (VRUS), and other companies developing hepatitis C drugs will present at the annual meeting of the American Association for the Study of Liver Diseases in San Francisco, a meeting that runs through November 8. Hepatitis C is an area of interest for a number of drug and biotech players. Though it has a budding blockbuster on the market with Incivek, Vertex faces potential competition from rivals working on improved treatments. (See Vertex Shatters Sales Goal for Hepatitis Drug.)

November 5
The annual scientific meeting of the American College of Rheumatology begins in Chicago and runs through November 9.

November 12
Alimera Sciences (ALIM) and pSivida (PSDV) expect to hear word from the FDA about possible approval of the drug Iluvien for an eye disease that causes blindness in diabetics. It's another try for the companies as the FDA rejected the application to sell Illuvien in late December. (See Alimera Shares Sink After FDA Rejects Eye Drug.)

November 16
An advisory committee of the FDA will discuss the design of clinical trials to evaluate the safety and effectiveness of Salix Pharmaceuticals' (SLXP) Xifaxan for irritable bowel syndrome with diarrhea. Salix lost almost a quarter of its value earlier this year on news that the drug was being rejected in the US for that use. (See Salix Tanks After Drug Setback.)

November 18
Regeneron Pharmaceuticals (REGN) expects to hear from the FDA on approval of Eylea for age-related macular degeneration, the leading cause of blindness in the elderly. This decision was scheduled for August but the FDA needed more time. (See Regeneron's Eye Drug Faces Delay.) The question for this company is whether "off-label" use of cancer drug Avastin will cut into Eylea's sales -- if the Regeneron drug is approved. (See Avastin Problems Are No Panacea for Regeneron.)

November 27
Transcept Pharmaceuticals (TSPT) is getting another shot at selling its sleeping pill for people who wake up in the middle of the night. Intermezzo was rejected by the FDA in 2009 and again in July because the agency was concerned about the risk of people taking the drug only a few hours before they have to wake. In early October, the company said the FDA was considering the drug again after the company provided the agency with more information. (See Transcept Pharmaceuticals Rises on Potential Sleeping Pill Approval.) That date is actually a Sunday. Look for a possible announcement the week of Thanksgiving.

Also, some companies will release third-quarter results. For instance, Dendreon (DNDN) is scheduled to release its numbers and hold a conference call Wednesday afternoon (November 2) after US markets close.

Twitter: @brettchase

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