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 BioMedTracker.com, 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)
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)
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)
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)
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.

Vivus ( VVUS)
Drug/indication: Qnexa for obesity
Approval decision date: July 17
A February FDA advisory panel voted 20-2 to support Qnexa's approval. FDA's decision was delayed by three months to allow the company and regulators to finalize a risk-management plan.

Amarin ( AMRN)
Drug/indication: AMR101 for treatment of patients with very high triglycerides
Approval decision date: July 26

Horizon Pharma ( HZNP)
Drug/indication: Lodotra for rheumatoid arthritis
Approval decision date: July 26

Progenics ( PGNX) and Salix Pharmaceuticals ( SLXP)
Drug/indication: Relistor SC for opioid-induced constipation
Approval decision date: July 27

Regeneron Pharmaceuticals and Sanofi ( SNY)
Drug/indication: Zaltrap for colon cancer
Approval decision date: Aug. 4
Zaltrap has posted mixed results in phase III clinical trials.

Ironwood Pharmaceuticals ( IRWD)
Drug/indication: Linaclotide for chronic idiopathic constipation and irritable bowel syndrome
Approval decision date: Sept. 8

Navidea Biopharmaceuticals ( NAVB)
Drug/indication: Lymphoseek, a radioactive tracing agent for lymph node mapping
Approval decision date: Sept. 10

Regeneron Pharmaceuticals
Drug/indication: Eylea for retinal vein occlusion
Approval decision date: Sept. 21
This is an expanded approval for Eylea, already approved for macular degeneration.

NPS Pharmaceuticals ( NPSP)
Drug/indication: Gattex for short bowel syndrome
Approval decision date: Sept. 28

Sanofi and Isis Pharmaceuticals ( ISIS)
Drug/indication: Kynamro for hypercholesterolemia
Approval decision date: Sept. 28

Raptor Pharmaceutical ( RPTP)
Drug/indication: RP103 for cystinosis
Approval decision date: Oct. 1

Celgene
Drug/indication: Abraxane for non-small cell lung cancer
Approval decision date: Oct. 12
Abraxane is already approved for the treatment of breast cancer.

Santarus ( SNTS)
Drug/indication: Uceris for ulcerative colitis
Approval decision date: Oct. 16

Impax Labs ( IPAX)
Drug/indication: IPX066 for Parkinson's disease
Approval decision date: Oct. 19

Dynavax ( DVAX)
Drug/indication: Heplisav for hepatitis B prevention
Approval decision date: Oct. 26

United Therapeutics ( UTHR)
Drug/indication: Oral Remodulin for pulmonary arterial hypertension
Approval decision date: Oct. 26

Cornerstone Therapeutics ( CRTX)
Drug/indication: Lixivaptan for hyponatremia
Approval decision date: Oct. 29

Celgene
Drug/indication: pomalidomide for refractory/relapsed multiple myeloma
Approval decision date: Fourth quarter
Celgene announced submission of the pomalidomide filing during the second quarter.

Biogen Idec ( BIIB)
Drug/indication: BG-12 for multiple sclerosis
Approval decision date: Dec. 28
BG-12 would be Biogen's first pill for multiple sclerosis.

--Written by Adam Feuerstein in Boston.

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