Below are companies with market caps under $250 million from the BioMedReports.com FDA Calendar, which have either pending FDA decisions or pending clinical trial results that may have a major impact on each of the underlying stock prices. A high risk/reward trading approach to consider for speculative traders is investing a small amount of money that you can afford to lose in a basket of stocks included in Extreme FDA and Clinical Trial Calendar Trades, which are highlighted in periodic articles at BioMedReports.com. Another approach is to simply buy such companies well ahead of their expected catalyst dates for a possible stock price increase as the date approaches and trading activity increases.

BioMimetic Therapeutics [BMTI: 9.07, -0.52 (-5.42%)]: On 6/17/09, BMTI announced that it has submitted both the pre-clinical pharmacology/toxicology and quality/manufacturing modules of its Premarket Approval (PMA) application for marketing of Augment Bone Graft

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.

Before reviewing the latest updates, below are two companies from the FDA Calendar with pending catalysts expected within the next week.

Savient Phama [SVNT: 12.06, -0.40 (-3.21%)] announced on 5/7/09 that its pending BLA for Krystexxa (pegloticase), a novel biological drug for

As a trio of U.S. small-cap drug makers await crucial Phase 3 results later this year; NeuroSearch [NEUR: 0.00, N/A (N/A)] [NEUSF: 0.00, N/A (N/A)] is preparing to advance its own experimental weight loss drug to the final stage of clinical development following a successful End of Phase 2 meeting with the FDA which was announced earlier this week. Arena Pharma [ARNA: 4.99, +0.09 (+1.84%)], Vivus [VVUS: 6.04, +0.23 (+3.96%)], and Orexigen Therapeutics [OREX: 4.02, +0.06 (+1.52%)] are all awaiting Phase 3 clinical trial data expected during 3Q09 for their experimental weight loss drugs to support NDA filings for FDA approval, which are summarized and tracked in the BioMedReports.com FDA Calendar. 

On 6/8/09, NeuroSearch announced that it has successfully completed its End of Phase 2 meeting with the FDA for tesofensine, a monoamine reuptake inhibitor in development as