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) 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.

Clinical trial results: A jam-packed calendar.

The list of companies with clinical trials expected to read out data before year-end is staggeringly long. The outcomes of these studies, more than anything else, may determine how the entire biotech sector ends 2012. Nothing moves a biotech stock -- up or down -- like important clinical trial data.

Phase III studies, all expecting results before the year ends: Amicus Therapeutics' ( FOLD) Amigal in Fabry disease; Biogen Idec's rFactor VIII for hemophilia A, rFactor IX for hemophilia B and dexpramipexole for amyotrophic lateral sclerosis (ALS) or Lou Gehrig's disease and Biomarin Pharmaceuticals' ( BMRN) GALNS for MPS IV also known as Morquio Syndrome.

More phase III studies: Acadia Pharmaceuticals' ( ACAD) pimavanserin in Parkinson's psychosis; Celsion's ( CLSN) Thermodox in liver cancer; Clovis Oncology's ( CLVS) CO-101 for pancreatic cancer; Ziopharm's ( ZIOP) palifosfamide for sarcoma; Celgene's ( CELG) Abraxane in melanoma and pancreatic cancer; and Exact Sciences' ( EXAS) Cologuard for colon cancer detection.

Like I said, a long list!

Some of the most impactful clinical data this fall will likely come from companies presenting updates of studies that have already been presented and caused a stir on Wall Street. Topping this list is Sarepta Therapeutics ( SRPT), which will be presenting additional (48 week) data from its eteplirsen muscular dystrophy study at the World Muscle Society meeting, Oct. 9-13.

Vertex Pharmaceuticals ( VRTX) will be a headliner at the cystic fibrosis meeting Oct. 11-13 with a detailed data presentation on the combination of Kalydeco and VX-809. Gilead Sciences ( GILD) is expected to present early "cure rate" data on its all-oral hepatitis C combination therapy of GS-7977 and GS-5885 at the AASLD Liver Meeting in November. Celldex Therapeutics ( CLDX) will present updated results from a phase II study of its immunotherapy CDX-011 at the San Antonio Breast Cancer Symposium in December. Threshold Pharmaceuticals ( THLD) should have survival data from the previously reported phase II study of TH-302 in pancreatic cancer.

A more complete list of clinical trials with looming data releases can be read here.

Drug launches and other questions: Overlook at your peril.

The most important "other question" in 2012 is the resolution of New Chemical Entity (NCE) status for Amarin's ( AMRN) Vascepa. Amarin is winning new patents for the prescription fill oil pill but still needs the market exclusivity that comes with NCE status. The next update is expected on Sept. 14.

While discussing Amarin, will the company find a partner to help launch Vascepa, or perhaps a buyer?

New drug launches to watch in the last four months of 2012: Medivation's Xtandi, Ironwood Pharmaceuticals' ( IRWD) Linzess, Onyx Pharma's ( ONXX) Kyprolis and Vivus' ( VVUS) Qsymia.

I can't mention Vivus and ignore Arena Pharmaceuticals ( ARNA), which is expected to receive DEA scheduling for Belviq before the end of the year so that the obesity drug can be launched early in 2013.

Will Peregrine Pharmaceuticals ( PPHM) sign a partner before starting the bavituximab phase III lung cancer study at year's end, as promised?

Same goes for YM BioSciences ( YMI): Where is the promised partner to co-develop the myelobfibrosis drug CYT387?

Can Idenix Pharmaceuticals ( IDIX) gather enough safety data to convince FDA to lift the clinical hold on its hepatitis C drugs? Will Achillion Pharmaceuticals ( ACHN), which like Idenix is seeking partners or buyers for its hepatitis C drugs, finally change its Facebook status to "In a Relationship?"

--Written by Adam Feuerstein in Boston.

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Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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