Biotech Investors: Mark Your 2005 Calendars

01/05/05 - 08:15 AM EST

Adam Feuerstein

Successful biotech investors stay on top of the calendar, because they need to be proactive about clinical data and Food and Drug Administration action dates. Regular readers have had an insatiable appetite for previous biotech catalyst calendars, so here's my latest for 2005. It's not comprehensive, and some of the dates are approximations, but this should give biotech investors a good road map for the upcoming year.

FDA Approvals/Filing Dates

American Pharmaceutical Partners (APPX Quote - Cramer on APPX - Stock Picks): Abraxane, breast cancer, Jan. 8, 2005;

Cyberonics(CYBX Quote - Cramer on CYBX - Stock Picks): VNS Therapy System, depression, Jan. 31, 2005;

Discovery Labs (DSCO Quote - Cramer on DSCO - Stock Picks): Surfaxin, respiratory distress syndrome (pediatrics), Feb. 13, 2005;

Millennium Pharmaceuticals(MLNM Quote - Cramer on MLNM - Stock Picks): Velcade, second-line multiple myeloma, March 29, 2005;

Celgene(CELG Quote - Cramer on CELG - Stock Picks): Revlimid, FDA filing for myelodysplastic syndrome (5 q minus), first quarter 2005. Revlimid, multiple myeloma phase III, second half 2005;

Cephalon(CEPH Quote - Cramer on CEPH - Stock Picks): Nuvigil, narcolepsy, sleep apnea, shift work sleep disorder FDA filing, first quarter 2005;

Amylin Pharmaceuticals (AMLN Quote - Cramer on AMLN - Stock Picks): Symlin, diabetes, March 20, 2005. Exenatide, diabetes, April 30, 2005;

Adolor(ADLR Quote - Cramer on ADLR - Stock Picks): Entereg, post-operative ileus, April 25, 2005;

ImClone Systems(IMCL Quote - Cramer on IMCL - Stock Picks): Erbitux, FDA filing for head and neck cancer, second quarter 2005.

Clinical Data

Aphton(APHT Quote - Cramer on APHT - Stock Picks): Insegia, gastrointestinal cancer phase III, first quarter 2005;

Genaera(GENR Quote - Cramer on GENR - Stock Picks): Squalamine, age-related macular degeneration phase II, first quarter 2005. Squalamine, age-related macular degeneration, phase III, year-end 2005;

Corgentech(CGTK Quote - Cramer on CGTK - Stock Picks): E2F Decoy, coronary artery bypass graft failure phase III, early 2005;

Cell Therapeutics(CTIC Quote - Cramer on CTIC - Stock Picks): Xyotax, non-small-cell lung cancer phase III, first quarter 2005;

Axonyx(AXYX Quote - Cramer on AXYX - Stock Picks): Phenserine, Alzheimer's disease phase II, first quarter 2005;

Encysive Pharmaceuticals(ENCY Quote - Cramer on ENCY - Stock Picks): Thelin, pulmonary arterial hypertension phase III, February 2005;

Biogen Idec(BIIB Quote - Cramer on BIIB - Stock Picks), Elan(ELN Quote - Cramer on ELN - Stock Picks): Tysabri, two-year multiple sclerosis data, first half 2005. Tysabri, Crohn's disease phase III (induction), rheumatoid arthritis phase II, midyear 2005;

Antigenics(AGEN Quote - Cramer on AGEN - Stock Picks): Oncophage, renal cell cancer phase III; second quarter 2005;

CV Therapeutics(CVTX Quote - Cramer on CVTX - Stock Picks): Ranexa, angina phase III, second quarter 2005;

Transkaryotic Therapies(TKTX Quote - Cramer on TKTX - Stock Picks): I2S, Hunter Syndrome phase III, June 2005. Dynepo, oncology phase III, first half 2005;

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

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