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 DatesAmerican 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; Millennium Pharmaceuticals ( MLNM): Velcade, second-line multiple myeloma, March 29, 2005; Celgene ( CELG): Revlimid, FDA filing for myelodysplastic syndrome (5 q minus), first quarter 2005. Revlimid, multiple myeloma phase III, second half 2005; Cephalon ( CEPH): Nuvigil, narcolepsy, sleep apnea, shift work sleep disorder FDA filing, first quarter 2005; Amylin Pharmaceuticals ( AMLN): Symlin, diabetes, March 20, 2005. Exenatide, diabetes, April 30, 2005; Adolor ( ADLR): Entereg, post-operative ileus, April 25, 2005; ImClone Systems ( IMCL): Erbitux, FDA filing for head and neck cancer, second quarter 2005.
Clinical DataAphton ( APHT): Insegia, gastrointestinal cancer phase III, first quarter 2005; Genaera ( GENR): Squalamine, age-related macular degeneration phase II, first quarter 2005. Squalamine, age-related macular degeneration, phase III, year-end 2005; Corgentech ( CGTK): E2F Decoy, coronary artery bypass graft failure phase III, early 2005; Cell Therapeutics ( CTIC): Xyotax, non-small-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; Biogen Idec ( BIIB), Elan ( ELN): Tysabri, two-year multiple sclerosis data, first half 2005. Tysabri, Crohn's disease phase III (induction), rheumatoid arthritis phase II, midyear 2005; Antigenics ( AGEN): Oncophage, renal cell cancer phase III; second quarter 2005; CV Therapeutics ( CVTX): Ranexa, angina phase III, second quarter 2005; Transkaryotic Therapies ( TKTX): I2S, Hunter Syndrome phase III, June 2005. Dynepo, oncology phase III, first half 2005; Onyx Pharmaceuticals ( ONXX): BAY 43-9006, renal cancer phase III interim analysis, first half 2005.
Abgenix ( ABGX), Amgen ( AMGN): ABX-EGF, third-line colon cancer study, second half 2005; Cypress BioScience ( CYPB): Milnacipran, fibromyalgia phase III, third quarter 2005; Genentech ( DNA): Lucentis, age-related macular degeneration phase IIII, third quarter 2005. Avastin, front-line lung cancer phase III, second half 2005; Allos Therapeutics ( ALTH): Efaproxyn, brain metastases from lung cancer phase III, fourth quarter 2005; Telik ( TELK): Telcyta, ovarian non-small-cell lung cancer phase III, fourth quarter 2005; Dendreon ( DNDN): Provenge, prostate cancer phase III, second half/fourth quarter 2005; Pharmacyclics ( PCYC): Xcytrin, brain metastases from lung cancer phase III, second half 2005. Northfield Laboratories ( NFLD): Polyheme, blood substitute trauma phase III, year-end 2005; CancerVax ( CNVX): Canvaxin, melanoma phase III, end of 2005.