Biotech Investors: Mark Your 2005 Calendars

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): 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;

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

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

Cephalon(CEPH Quote): Nuvigil, narcolepsy, sleep apnea, shift work sleep disorder FDA filing, first quarter 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;

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

Clinical Data

Aphton(APHT Quote): Insegia, gastrointestinal cancer phase III, first quarter 2005;

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

Corgentech(CGTK Quote): E2F Decoy, coronary artery bypass graft failure phase III, early 2005;

Cell Therapeutics(CTIC Quote): Xyotax, non-small-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;

Biogen Idec(BIIB Quote), Elan(ELN Quote): 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): Oncophage, renal cell cancer phase III; second quarter 2005;

CV Therapeutics(CVTX Quote): Ranexa, angina phase III, second quarter 2005;

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

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