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) and Elan(ELN): Antegren, multiple sclerosis, Nov. 25;

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

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

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

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

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

OSI Pharmaceuticals(OSIP) and Genentech(DNA): 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): Abraxane, breast cancer, Jan. 8, 2005;

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

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

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

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

Clinical Data:

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

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

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

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

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

Corgentech(CGTK): 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): Xyotax, nonsmall cell lung cancer phase III, first quarter 2005;

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

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

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

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