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Biotech Stock Mailbag: Most Important Events for 2012

BOSTON ( TheStreet) -- Happy holidays and welcome to the last Biotech Stock Mailbag of 2011. Let's look ahead to see what our little corner of the investing world has in store for us in 2012.

Howard M. writes: "Adam. Thanks for all you do, especially the live blogs which are great. What are you looking at when it comes to biotech stocks in 2012?"

I'm just wrapping my head around 2012 now and will certainly have more to say in January after I spend a week in San Francisco immersed in biotech at the JPMorgan Healthcare Conference (Jan. 9-12). Stay tuned for wall-to-wall coverage.

Like in previous years, the release of clinical results from phase III and selected phase II studies in 2012 will probably produce the most significant volatility in biotech stock prices.

Meaningful clinical trials results in 2012 to start thinking about now include two phase III studies of cancer immunotherapies, or "vaccines." These are Oncothyreon's (ONTY) Stimuvax in non-small cell lung cancer (data in first quarter) and Vical's (VICL - Get Report) Allovectin in melanoma (data mid-year.) I've already predicted failure for both but obviously plenty of people disagree and believe one or both of these therapies will succeed. Differences of opinion are what makes markets.

Keryx Pharmaceuticals (KERX - Get Report) is expecting phase III data on perifosine in colon cancer in the first quarter. The outcome of the study will also affect the value of Aeterna Zentaris (AEZS) because it owns ex-U.S. rights to the drug. (Again, I'm bearish here.)

Alzheimer's disease returns to Wall Street in 2012 with data likely from phase III studies of Eli Lilly's (LLY) solanezumab and Johnson & Johnson's (JNJ) bapineuzumab. ( Pfizer (PFE) and Elan (ELN) also have financial interests in bapineuzumab.)

Celgene (CELG - Get Report): Phase III studies of oral apremilast in psoriasis and psoriatic arthritis due in the second half of the year. In Europe, Celgene is awaiting a very important decision from regulators about front-line approval for the multiple myeloma drug Revlimid.

Gilead Sciences (GILD - Get Report) will find out if its $11 billion acquisition of Pharmasset (VRUS) was worth it with results from several studies of Pharmasset's lead hepatitis C drug PSI-7977 expected in 2012.

Looking at phase II studies, I'd pay attention to Threshold Pharmaceuticals (THLD - Get Report) and its mid-stage study of TH-302 in pancreatic cancer. Results expected mid-to-late February. Celldex Therapeutics (CLDX - Get Report) will have data from a phase II study of CDX-011 in breast cancer ready in the first half of the year.
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CELG $108.03 1.77%
CLDX $4.19 2.70%
GILD $91.14 -9.50%
KERX $5.26 3.54%
ONTY $1.32 2.30%


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