Auxilium Pharma (AUXL) is currently awaiting a decision from the U.S. Food and Drug Administration (FDA) on its key pipeline candidate, Xiaflex, which is under FDA review for the treatment of Dupuytren’s Contracture. In September, Auxilium received a major boost in the form of a favorable recommendation from the FDA’s Arthritis Advisory Committee for Xiaflex for the treatment of Dupuytren’s Contracture.   Dupuytren’s Contracture is a condition that affects the connective tissue in the palm known as palmar fascia. The company estimates that approximately 240,000 Dupuytren’s candidates could exist in the U.S. and the EU. This represents significant commercial opportunity for Auxilium.   Xiaflex is also being studied for the treatment of Peyronie’s disease and frozen shoulder syndrome. According to the company, there are at least 450,000 potential patients annually in the U.S. and the EU for Dupuytren’s and Peyronie’s. Approval for both indications could help Xiaflex sales ...

FDA advisory panel has backed and given a green signal to Auxilium Pharmaceutical’s experimental Xiaflex therapy which cures Dupuytren’s contracture. The FDA panel has stated that the Xiaflex therapy is absolutely effective and safe and a better alternative to surgery as a treatment for a condition that affects the connective tissues in the hand. With this approval by FDA, Auxilium’s share prices have been stable for sometime as investors are waiting for what’s the next step, to make sure they have invested in the right place at the right time. This is not only a good news for Auxilium Pharmaceuticals but also ...

On March 2, 2009, Auxilium Pharmaceuticals (AUXL) submitted a biologic license application (BLA) to the U.S. FDA for Xiaflex seeking approval for the treatment of Dupuytren's contracture.The BLA filing represents a major milestone for the company and, if approved, would put the company squarely on the path to sustained profitability.On June 18, 2009, the U.S. FDA noted that its Division of Anesthesia, Analgesia and Rheumatology Products (DAARP) will hold an Arthritis Advisory Committee to discuss the pending application on September 16, 2009.Although this meeting has been scheduled for a month after the PDUFA action date of August 28, 2009, we are pleased to hear that hand and/or other orthopedic surgeons (potential users of the product) will be on the panel. We think that approval is likely after the panel meeting, probably in October or November 2009.The next potential ...

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 [ANPI: 1.97, 0.00 (0.00%)] – currently trading at $2.14, market cap = $182 million

ANPI has an FDA-approved dialysis catheter (HemoStream) that is sold through its direct sales

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