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Biotech Investors: Mark Your 2005 Calendars

Here's a list of events that could dictate trading. Plus, Adam Feuerstein's new challenge.

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


: Abraxane, breast cancer, Jan. 8, 2005;



: VNS Therapy System, depression, Jan. 31, 2005;

Discovery Labs


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

Millennium Pharmaceuticals


: Velcade, second-line multiple myeloma, March 29, 2005;



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



: Nuvigil, narcolepsy, sleep apnea, shift work sleep disorder FDA filing, first quarter 2005;

Amylin Pharmaceuticals


: Symlin, diabetes, March 20, 2005. Exenatide, diabetes, April 30, 2005;



: Entereg, post-operative ileus, April 25, 2005;

ImClone Systems


: Erbitux, FDA filing for head and neck cancer, second quarter 2005.

Clinical Data



: Insegia, gastrointestinal cancer phase III, first quarter 2005;



: Squalamine, age-related macular degeneration phase II, first quarter 2005. Squalamine, age-related macular degeneration, phase III, year-end 2005;



: E2F Decoy, coronary artery bypass graft failure phase III, early 2005;

Cell Therapeutics


: Xyotax, non-small-cell lung cancer phase III, first quarter 2005;



: Phenserine, Alzheimer's disease phase II, first quarter 2005;

Encysive Pharmaceuticals


: Thelin, pulmonary arterial hypertension phase III, February 2005;

Biogen Idec





: Tysabri, two-year multiple sclerosis data, first half 2005. Tysabri, Crohn's disease phase III (induction), rheumatoid arthritis phase II, midyear 2005;



: Oncophage, renal cell cancer phase III; second quarter 2005;

CV Therapeutics


: Ranexa, angina phase III, second quarter 2005;

Transkaryotic Therapies


: I2S, Hunter Syndrome phase III, June 2005. Dynepo, oncology phase III, first half 2005;

Onyx Pharmaceuticals


: BAY 43-9006, renal cancer phase III interim analysis, first half 2005.






: ABX-EGF, third-line colon cancer study, second half 2005;

Cypress BioScience


: Milnacipran, fibromyalgia phase III, third quarter 2005;



: Lucentis, age-related macular degeneration phase IIII, third quarter 2005. Avastin, front-line lung cancer phase III, second half 2005;

Allos Therapeutics


: Efaproxyn, brain metastases from lung cancer phase III, fourth quarter 2005;



: Telcyta, ovarian non-small-cell lung cancer phase III, fourth quarter 2005;



: Provenge, prostate cancer phase III, second half/fourth quarter 2005;



: Xcytrin, brain metastases from lung cancer phase III, second half 2005.

Northfield Laboratories


: Polyheme, blood substitute trauma phase III, year-end 2005;



: Canvaxin, melanoma phase III, end of 2005.

Turning the Page

On a calendar note of a personal sort, today marks my last day at


After four wonderful years here and 15 years as a business journalist, it's time for a new challenge. Next week, I'll be joining a New York-based investment firm as a biotech analyst (I'll remain on the West Coast.) I've been writing about biotech investing for a long time, so now's my chance to see if I can actually invest in biotech -- and make money doing it.

I'm excited to start the new gig, but I leave

with some reluctance, because this has been (and continues to be) a great place to work and learn. I look back over the past four years and I marvel at how much I've learned about the way Wall Street really works. My investment education only accelerated when I was fortunate to join the staff of


two years ago.

Thanks to Jim Cramer, Dave Morrow, the entire cast of


contributors and all the writers and editors at


. It's been a great ride.

Finally, thanks to all my readers! Your constant feedback -- both naughty and nice -- kept me constantly energized and on my toes. I met some amazingly smart and friendly people through this Web site, readers who became trusted sources and helped me appear smarter than I am. I'm thankful and better for it, and will miss that part of the job more than anything.

Next week, I stop watching and start doing. I can't wait to get started. Thanks again, and continued success to all.

Adam Feuerstein writes regularly for In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in He also doesn't invest in hedge funds or other private investment partnerships. He invites you to send your feedback to