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29 Drugs Facing FDA Approval in 2012

Calendar updated to include several drug approvals inadvertently omitted.

BOSTON ( TheStreet) -- Here's an updated list of biotech and pharmaceutical companies with pending FDA drug approval decisions for the rest of 2012.

The calendar on the following pages captures the most important U.S. regulatory events -- FDA drug approvals and advisory panels -- expected between May and December 2012. As every savvy biotech investor and trader knows, the volatility in biotech and drug stocks ramps significantly as U.S. regulators weigh whether to approve or reject new drugs.

Biotech and drug stocks below are listed in chronological order based on the closest regulatory catalyst. The calendar was compiled with some assistance from, a very useful database of experimental drug and drug-development catalysts compiled by Sagient Research.

Alexza Pharmaceuticals (ALXA)
Drug/indication: Adasuve for agitation related to schizophrenia
Approval decision date: May 4
A drug inhaled into the lungs, a split FDA advisory panel vote and lingering safety concerns make Adasuve's approval odds a tough call.

Regeneron Pharmaceuticals (REGN - Get Report)
Drug/indication: Arcalyst for prevention of gout flares
FDA advisory panel date: May 8
Approval decision date: July 30
This will be the second approved indication for Arcalyst, which is currently marketed as a treatment for cryopyrin-associated periodic syndromes (CAPS).

Pfizer (PFE - Get Report)
Drug/indication: Tofacitinib for rheumatoid arthritis
FDA advisory panel date: May 9
Approval decision date: August (exact date not specified)
Tofacitinib would be the first pill approved for the treatment of rheumatoid arthritis, competing with established injectable drugs like Abbbot's Humira.

Arena Pharmaceuticals (ARNA - Get Report)
Drug/indication: Lorcaserin for obesity
FDA advisory panel date: May 10
Approval decision date: June 27
This is the second review cycle for lorcaserin.

Gilead Sciences (GILD)
Drug/indication: Quad for HIV
FDA advisory panel date: May 11
Approval decision date: Aug. 27
Quad combines four Gilead drugs into a single, once-daily pill for HIV. The new (and still experimental) components in the Quad are the integrase inhibitor elvitegravir and cobicistat, which is used to boost blood levels of elvitegravir.

Talon Therapeutics (TLON)
Drug/indication: Marqibo for advanced acute lymphoblastic leukemia
Approval decision date: May 13
In March, an FDA advisory panel voted to recommend approval of Marqibo.

Merck (MRK) and Ariad Pharmaceuticals (ARIA)
Drug/indication: Taltorvic for sarcoma
Approval decision date: June 5
In March, an FDA advisory panel recommended against approval of Taltorvic.

Roche (RHHBY)
Drug/indication: Pertuzumab for HER2-positive metastatic breast cancer
Approval decision date: June 8

Onyx Pharmaceuticals (ONXX)
Drug/indication: Carfilzomib for relapsed/refractory multiple myeloma
FDA advisory panel date: June 20
Approval decision date: July 27

Bristol-Myers Squibb (BMY) and Pfizer
Drug/indication: Eliquis for stroke prevention in patients with atrial fibrillation
Approval decision date: June 28
FDA delayed the Eliquis approval decision by three months.

Celgene (CELG - Get Report)
Drug/indication: Revlimid in first-line multiple myeloma
European approval decision date: Second or third quarter
This calendar is focused on U.S. regulatory decisions, but Celgene's efforts to get Revlimid approved as a first-line treatment for multiple myeloma in Europe is crucial for the company's growth and stock price.
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ONXX $0.00 0.00%
ARNA $1.58 -2.50%
CELG $100.89 -2.30%
PFE $33.42 -0.83%
REGN $360.66 -2.90%


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