December 28, 2009

Biotech/Pharma Stocks and Upcoming FDA Actions Dates

A few biotech stocks whose FDA approval/response dates are coming up are listed here without any analysis or predictions. Momentum traders could use these tickers, study the stock behavior and make appropriate trades. Or look at the drug/device's long term trial/data process and make bets on either side of the trade and hold steady. Good luck and don't be greedy. Stocks are listed from the nearest date of decision onward. Thanks for a diligent poster (sxyam) on the yahoo message board of HUN.
Chelsea Therapeutics(CHTP Quote)
Drug/indication: Droxidopa for neurogenic orthostatic hypotension
Outcome of FDA meeting to discuss changing primary endpoint of phase III study: December 2009.

Cephalon(CEPH Quote)
Drug/indication: Nuvigil for jet lag disorder
FDA approval decision date: Dec. 29

Arena Pharmaceuticals(ARNA Quote)
Drug/indication: lorcaserin for obesity
Filing for FDA approval: December 2009

Auxilium Pharmaceuticals(AUXL Quote)
Drug/indication: Xiaflex for Dupuytren's contracture
FDA approval decision date: December 2009

Biodel(BIOD Quote)
Drug/indication: Viaject for diabetes
Filing for FDA approval: December 2009

Novartis(NVS Quote)
Drug/indication: fingolomid for multiple sclerosis
Filing for FDA approval: December 2009

Novo Nordisk(NVO Quote)
Drug/indication: Victoza for diabetes
FDA approval decision date: December 2009

Shire Pharmaceuticals(SHPGY Quote)
Drug/indication: Replagal for Fabry's disease
Filing for FDA approval: December 2009

Vivus(VVUS Quote)
Drug/indication: Qnexa for obesity
Filing for FDA approval: December 2009

Mannkind(MNKD Quote)
Drug/indication: Afresa for diabetes
FDA approval decision date: Jan. 16, 2010

Acorda Therapeutics(ACOR Quote)
Drug/indication: Amaya for multiple sclerosis
FDA approval decision date: Jan. 22, 2010

Spectrum Pharmaceuticals(SPPI Quote)
Drug/indication: Fusilev for colon cancer
Outcome of meeting with FDA to discuss complete response letter: January 2010

Labopharm(DDSS Quote)
Drug/indication: Trazodone Contramid for depression
FDA approval decision date: Feb. 11, 2010

Cadence Pharmaceuticals(CADX Quote)
Drug/indication: acetavance for pain
FDA approval decision date: Feb. 12, 2010

Gilead Sciences(GILD Quote)
Drug/indication: Cayston for cystic fibrosis
FDA approval decision date: Feb. 13, 2010

Salix Pharmaceuticals(SLXP Quote)
Drug/indication: Xifaxan for hepatic encephalopathy
FDA advisory committee meeting: February 2010
FDA approval decision date: March 24, 2010

Shire Pharmaceuticals(SHPGY Quote)
Drug/indication: velaglucerase for Gaucher's disease
FDA approval decision date: Feb. 28, 2010

Amylin Pharmaceuticals(AMLN Quote)
Drug/indication: Exenatide LAR for diabetes
FDA approval decision date: March 5, 2010

Clinical Data(CLDA Quote)
Drug/indication: vilazodone for depression
Filing for FDA approval: First quarter 2010

Somaxon Pharmaceuticals(SOMX Quote)
Drug/indication: Silenor for insomnia
Outcome of FDA meeting to discuss complete response letter: First quarter 2010

Cell Therapeutics(CTIC Quote)
Drug/indication: pixantrone for non-Hodgkin's lymphoma
FDA approval decision date: April 23, 2010

Eli Lilly(LLY Quote)
Drug/indication: Erbitux for first-line non-small cell lung cancer
Filing for FDA approval: First quarter 2010

Dendreon(DNDN Quote)
Drug/indication: Provenge for prostate cancer
FDA approval decision date: May 1, 2010

Avanir Pharmaceuticals(AVNR Quote)
Drug/indication: Zenvia for pseudobulbar effect
Filing for FDA approval: Second quarter 2010

Alkermes(ALKS Quote)
Drug/indication: Vivitrol for opioid addiction
Filing for FDA approval: First half 2010

InterMune(ITMN Quote)
Drug/indication: pirfenidone for idiopathic pulmonary fibrosis
FDA advisory committee meeting: First half 2010

FDA approval decision date: Second half 2010

Human Genome Sciences(HGSI Quote)
Drug/indication: Benlysta for lupus
Filing for FDA approval: First half 2010

Orexigen Therapeutics(OREX Quote)
Drug/indication: Contrave for obesity
Filing for FDA approval: First half 2010

No comments:

Post a Comment

Your comments and opinions here!

Join the Discussion