Heads Up, Biotech Investors

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Biotech investors, mark your calendars and update your watch lists with the dates and companies in this report. Major catalysts are coming down the pike for these companies in the form of FDA decisions and reports of clinical trial data. I have put together a list of companies ranging from around $100 million to just over $1 billion in market cap that are expected to be on the move within the next nine months. Some are well known and heavily traded, while others may be new to you and worthy of further investigation.

Dendreon (Nasdaq: DNDN) has a well-known FDA decision deadline of May 15 for its experimental prostate cancer immunotherapy Provenge. An FDA advisory panel recently gave Provenge the thumbs-up, which bodes well for approval, as the FDA tends to follow the recommendations of these panels. Please see my article from last week for my full take on the stock.

EXACT Sciences (Nasdaq: EXAS) will be presenting positive clinical results later this month for its DNA-based, noninvasive stool screening tests for colorectal cancer and inflammatory bowel disease. More importantly, guidelines expected to be revised in the next few months may include the company's test for colorectal cancer screening. I recently wrote an article on EXACT, which you can check out if you'd like more information on this small-cap company.

Neurochem (Nasdaq: NRMX) is expected to release top-line results for its experimental Alzheimer's drug, Alzhemed, between now and the end of the quarter. The company most recently announced adjustments to the statistical model for this trial that were consistent with previous discussions with the FDA. However, investor pessimism and analyst downgrades over inability to partner Alzhemed prior to trial results have sent shares down about 40% year to date and 20% in the last month alone.

The Fool's CAPS community is not optimistic about Neurochem's prospects. The stock has a lowly one-star rating and bears outnumber the bulls by a two-to-one margin.

Pozen (Nasdaq: POZN) expects to receive an FDA decision for its combination migraine drug, Trexima, by Aug. 1, following several delays over the past year that required the company to submit additional information. Trexima is a combination of existing drugs naproxen and sumatriptan (Imitrex is the brand name) that has shown effectiveness versus placebos and both drugs used alone. It appears to have a high likelihood of approval and launch by year-end.

Progenics (Nasdaq: PGNX) has an FDA deadline of Jan. 30, 2008, for its subcutaneous injection methylnaltrexone, which treats constipation resulting from use of opiate pain killers. The drug is a modified version of already-marketed naltrexone intended to block the constipating effect while not interfering with pain relief. Progenics and its partner Wyeth have the inside track for this indication since competitor Adolor (Nasdaq: ADLR) reported safety concerns for Entereg last month.

Zymogenetics (Nasdaq: ZGEN) has an FDA decision date of Oct. 18 for its experimental thrombin nasal spray to control bleeding during surgery. The company reported in March that it would not be required to conduct additional trials, saving about 18 months and substantial cash in the development of the highly purified form of thrombin that is not derived from animal or human blood.

Keep in mind this is not meant to be an exhaustive list of all companies in the sector, and I purposely excluded the biggest and most well-known biotech and big pharma companies. My goal is to provide a small selection of companies with a combination of leverage because of their smaller size and a major upcoming catalyst in the way of clinical trial data or FDA decision deadlines. Those two factors can lead to big moves in share prices, which makes these companies worth watching.

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Fool contributor Mike Havrilla, R.Ph., B.S., Pharm.D., is a Rite Aid pharmacist who lives and works in the small Pennsylvania town of Portage. He invites your comments and feedback. Mike does not have a position in any company mentioned here. The Fool has a disclosure policy.