OT-Expected FDA Decision Date Company Drug Indication - from The Street (Adam Feuerstein)i.e.
Drug approval decisions by the Food and Drug Administration can be important stock-moving events. But putting together a calendar of these potential catalysts can be difficult.
The FDA's Web site isn't very helpful, and unless you have access to scores of sell-side research reports, you're pretty much on your own.
Here's a list of key upcoming FDA drug approval decisions for the rest of the year. This isn't comprehensive, but it does cover most, if not all, new drugs being developed by biotech firms. There are a few specialty pharma and Big Pharma drugs on the list, too.
6/15/2007 Encysive Pharmaceuticals Thelin Pulmonary Arterial Hypertension (PAH)
6/16/2007 Cephalon Nuvigil Narcolepsy
6/16/2007 Cephalon Nuvigil Sleep Apnea
6/18/2007 Gilead Sciences Volibris Pulmonary Arterial Hypertension (PAH)
Now-06/30/2007 Pfizer Celsentri HIV/AIDS
7/16/2007 Neurochem Kiacta Amyloid A Amyloidosis
7/21/2007 DOR BioPharma OrBec Graft vs. Host Disease (GVHD)
7/26/2007 Sanofi-Aventis Zimulti Obesity
7/29/2007 KV Pharmaceutical Evamist Menopause
8/1/2007 POZEN Trexima Migraine Headaches
8/13/2007 Indevus Pharmaceuticals Sanctura XR Overactive Bladder
8/15/2007 GPC Biotech Satraplatin Prostate Cancer
8/26/2007 IDM Pharma Junovan Bone Cancer
8/30/2007 Tercica Somatuline Autogel Acromegaly
9/6/2007 Omrix Pharmaceuticals Thrombin Hemostasis
10/7/2007 Theravance Telavancin Skin and Skin-Structure Infections
10/15/2007 Elan/Biogen Idec Tysabri Crohn's Disease
10/18/2007 ZymoGenetics rThrombin Hemostasis
10/18/2007 Cardiome Pharma Vernakalant hydrochloride (iv) Dysrhythmia (Arrhythmia)
10/20/2007 Pfizer Lyrica Fibromyalgia
10/21/2007 Genzyme Renvela End-Stage Renal Disease (ESRD)
11/1/2007 Forest Laboratories Nebivolol Hypertension (Systemic)
11/18/2007 Basilea Pharmaceutica Ceftobiprole Skin and Skin-Structure Infections
11/24/2007 BioMarin Pharmaceutical Kuvan Phenylketonuria (PKU)
12/31/2007 Pharmacyclics Xcytrin Brain Cancer (secondary; metastases)
Source: Biomedtracker, analyst research reports