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The Essential 2012 Biotech Stock Fall Preview

BOSTON ( TheStreet) -- The roster of important biotech catalysts for the remaining four months of 2012 is deep. FDA drug approvals, clinical trial results and new drug launches are going to keep investors busy all the way through New Year's Eve. We might even see more acquisitions to pad what's already been an active year on the deal-making front.

The biotech sector is having a good year. The Nasdaq Biotechnology Index is up 34% year-to-date compared to a 12% rise in the S&P 500. Putting aside the outcome of the presidential election and the health of the U.S. and world economies, the biotech sector's ability to close out 2012 on a strong note will depend largely on the success or failure of upcoming regulatory and clinical events.

Here's my take on the most important biotech catalysts heading into the home stretch of 2012:

FDA Drug Approvals: More, please, and fast!

Last week's U.S. approval of Xtandi, the new prostate cancer drug from Medivation (MDVN), came three months earlier than expected. I hesitate to draw firm conclusions, but it certainly seems as if FDA is trying to complete drug reviews more quickly with the aim of pushing approvals out the agency's door ahead of schedule. [It certainly helps when drugs are submitted to FDA with data packages as strong and worthy of speedy approval like Xtandi.]

Looking at the calendar of pending drug approvals for the rest of 2012, I'd say Ariad Pharmaceuticals' (ARIA - Get Report) leukemia drug ponatinib has a decent shot for a quick review and earlier-than-expected approval -- perhaps as early as December, maybe January 2013.

I'd put Exelixis' (EXEL) thyroid cancer drug cabozantinib in the same boat. The "official" FDA approval decision date is Nov. 29 but the agency decided to cancel an advisory panel previously scheduled for Nov. 9. That might be a signal that FDA has no outstanding issues with cabozantinib, which could lead to a faster approval.

Other pending FDA drug approval decisions of note: Biogen Idec's (BIIB) first multiple sclerosis pill, BG12, on Dec. 28; Pfizer's (PFE) tofacitinib, the first rheumatoid arthritis pill, on Nov. 21; and NPS Pharmaceuticals' (NPSP) Gattex for short-bowel syndrome on Dec. 28 (preceded by an advisory panel meeting on Oct. 16.)

I published a more complete FDA drug approval decision calendar in August so make sure to check it out.
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