Biotech Investors: Mark Your Calendars, Redux

Successful biotech investors keep a close eye on the calendar. Regulatory decisions and clinical trial results move this sector, so it's important to stay on top of these events whenever possible.

To help readers, I've put together another list of biotech catalyst events for the remainder of this year and the beginning of 2005. This calendar builds upon a similar list I put together in September. Judging by the large volume of email I received after that column was published, a biotech calendar is something a lot of people find extremely valuable.

In the interest of brevity, I've kept descriptions here to a minimum, but I'll likely cover many of these events in more detail in the future.

FDA Approval Decision Dates:

Biogen Idec (BIIB Quote) and Elan(ELN Quote): Antegren, multiple sclerosis, Nov. 25;

SuperGen(SUPG Quote): Orathecin, pancreatic cancer, Nov. 26;

United Therapeutics(UTHR Quote): Remodulin (intravenous formulation), pulmonary arterial hypertension, Nov. 30;

Sepracor(SEPR Quote): Estorra, insomnia, Dec. 15;

Eyetech Pharmaceuticals (EYET Quote) and Pfizer(PFE Quote): Macugen, age-related macular degeneration, Dec. 17;

Genzyme(GENZ Quote) and Bioenvision(BIVN Quote), Clofarabine, acute pediatric leukemia, Dec. 30;

OSI Pharmaceuticals(OSIP Quote) and Genentech(DNA Quote): Tarceva, non-small-cell lung cancer, Jan. 30, 2005. (OSI has said it expects approval decision to come earlier than Jan. 30, but the company is not any more specific.);

American Pharmaceutical Partners(APPX Quote): Abraxane, breast cancer, Jan. 8, 2005;

Cyberonics(CYBX Quote): VNS Therapy System, depression, Jan. 31, 2005;

Discovery Labs(DSCO Quote): Surfaxin, respiratory distress syndrome (pediatrics), Feb. 13, 2005;

Amylin Pharmaceuticals(AMLN Quote): Symlin, diabetes, March 20, 2005. Exenatide, diabetes, April 30, 2005;

Adolor(ADLR Quote): Entereg, post-operative ileus, April 25, 2005.

Clinical Data:

Celgene(CELG Quote): Revlimid, myelodysplastic syndrome phase II, Dec. 4-7, 2004;

Atherogenics(AGIX Quote): AGI-1067, atherosclerosis, end of 2004;

Pharmos(PARS Quote): Dexanabinol, traumatic brain injury phase III, end of 2004;

Aphton(APHT Quote): Insegia, gastrointestinal cancer phase III, end of 2004;

Isis Pharmaceuticals(ISIS Quote): Alifacorsen, Crohn's disease phase III, ulcerative colitis phase II, end of 2004;

Corgentech(CGTK Quote): E2F Decoy, peripheral bypass graft failure phase III, late fourth quarter 2004; E2F Decoy, coronary artery bypass graft failure phase III, early 2005;

Cell Therapeutics(CTIC Quote): Xyotax, nonsmall cell lung cancer phase III, first quarter 2005;

Axonyx(AXYX Quote): Phenserine, Alzheimer's disease, phase II, first quarter 2005;

Encysive Pharmaceuticals(ENCY Quote): Thelin, pulmonary arterial hypertension phase III, February 2005;

Onyx Pharmaceuticals(ONXX Quote): BAY 43-9006, renal cancer phase III interim analysis, first half 2005.