The Essential 2012 Biotech Stock Fall Preview

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.

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