FDA

[biomanbaba]

It’s not always easy being a biotech investor. The stocks are driven by very specific events that can make them shoot up 200% overnight or just as quickly lose all of their value. Marking these events on your calendar can help you plan for those times when there's the possibility a good trade could go bad.

These events usually include the announcement of clinical trial data and PDUFA dates (the day the FDA will decide approval by), as well as FDA advisory committee meetings.

Some events to watch out for this year include Somaxan's (SOMX) day in front of the FDA on March 21 for its insomnia drug Silenor. The drug’s safety and efficacy profiles could be a hindrance to the current drugs on the market, which all have the potential to be abused and can cause side effects like memory loss and residual effects the next day. The drug got a complete response letter in December, but Somaxan has now provided all the additional information the FDA should need for approval.

(Update: Just as this story went to press, Somaxan announced that the FDA approved Silenor before its March 21 date. The news sent the shares up 134%)

Keep an eye on Cell Therapeutics (CTIC) on the following day when its non-Hodgkin's lymphoma drug pixantrone finally steps in front of an FDA advisory panel. The original meeting was set for January 31, but was postponed due to the severe weather that hit the capital. (See Cell Therapeutics’ Last Hope for Survival, Dashed.)

May 1 is the big day for Dendreon (DNDN) and its prostate cancer vaccine Provenge. The drug and the company have had a dramatic couple of years, but investors and analysts are bullish on the drug finally getting approved by the FDA that day. (See Dendreon and the Prostate Cancer Battle.)

A few other companies are planning to announce clinical trial data in the next few months and, while those dates aren't exact, they can help investors know what to expect. GenVec (GNVC) is likely to announce interim data on its TNFerade pancreatic cancer drug sometime before the end of the month or in early April. The study is comparing the drug plus the current standard of care against the current standard of care alone.

Allos Therapeutics (ALTH) will be announcing results of a mid-stage study of its blood cancer drug Folotyn for the treatment of non-small cell lymphoma. The drug was approved in September for peripheral T-cell lymphoma and positive results in another indication could greatly expand the drug's market.

October will be a month of feast or famine for two biotechs that are awaiting approval of their obesity-fighting drugs. Arena Pharmaceuticals' (ARNA) Lorcaserin will face the FDA on October 22, while Vivus (VVUS) will get a decision on Qnexa a few days later on October 28.

The weight-loss category is one of the only untapped markets for pharmaceuticals; if approved, this category of drugs could offer the next blockbusters.

According to a recent report by the Centers for Disease Control and Prevention, obesity-related health-care costs totaled $117 billion in 2000. Between 1987 and 2001, diseases associated with obesity accounted for 27% of the increases in medical costs. (See Biotech's Race to Battle the Bulge.)