Below are four companies with market caps under $200 million (all financial data current as of 6/9/09 during intraday trading) which have pending FDA decisions and/or 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.
1.) Angiotech Pharma (NASDAQ:ANPI) - currently trading at $2.14, market cap = $182 million
ANPI has an FDA-approved dialysis catheter (HemoStream) that is sold through its direct sales force. The Company has identified 5-Fluorouracil ("5-FU"), a drug previously approved by the FDA for treatment of various types of cancer, as a compound that may help to prevent certain types of infection in patients receiving selected types of implantable devices, including certain dialysis catheters. ANPI is currently developing this 5-FU anti-infective technology for its HemoStream dialysis catheter line, and expects to file for a 510(k) clearance to market this product candidate in the U.S. during 2009.
On 5/8/09, ANPI provided an update in its SEC 10Q filing for the Zilver PTX paclitaxel-eluting peripheral vascular stent, which is currently being evaluated in multiple clinical trials by partner Cook Medical, Inc. as a specialized stent product incorporating Angiotech's proprietary paclitaxel technology that is designed for placement in diseased arteries in the limbs to restore blood flow. In July 2007, Cook announced that the first U.S. patients in a randomized pivotal human clinical trial of Zilver PTX were treated in a study that is designed to randomize patients to receive either the Zilver PTX stent or balloon angioplasty. Data from this clinical trial is intended to be used to support submission to the FDA for approval in the U.S. to market the device.
In September 2008, Cook announced it had completed enrollment in its pivotal human clinical trial for the Zilver PTX. The 420 patients enrolled in Cook's randomized trial include peripheral artery disease patients treated in Germany, the U.S., and Japan. On the same date, Cook announced that it had enrolled an additional 780 patients in the E.U, Canada, and Korea in a clinical registry to evaluate the safety of the Zilver PTX device. Those data have been used for submission in Europe for CE Mark approval to market the device in the E.U.
