Biotech Clinical Trials Update

 |  Includes: GSK, IPXL, UTHR
by: Roger Newman

This is one in a series of articles that highlight recent clinical trial updates for new drugs in the FDA approval process. A brief overview of the FDA approval process can be found here.

United Therapeutics Corporation (NASDAQ:UTHR) reported the completion of its FREEDOM-C(2) Phase 3 trial of a sustained release formula of treprostinil in patients with pulmonary hypertension. The primary endpoint, a six-minute walk distance at week 16 was not reached. Despite this result, UTHR President and COO Roger Jeffs said that they still believe an NDA filing is warranted in treatment naive patients based on the previously announced FREEDOM-M study. UTHR traded down nearly 20% on the news despite the positive comments by Jeffs. As of the end of July, UTHR had nearly 5.5 million shares sold short, or just over 6 days to cover. UTHR has a $2.8 billion market cap.

Impax Laboratories, Inc. (NASDAQ:IPXL) and GlaxoSmithKline (NYSE:GSK) announced top-line results of the ASCEND-PD Phase 3 trial of their compound IPX066 in patients with advanced Parkinson's disease. IPX066 is under investigation for treatment of the motor symptoms of Parkinson's. The primary endpoint was a measure of "off time," or time during waking hours in which the patient suffered motor symptoms. There was a 33.5% reduction in "off time" for the treated patients leading to a greatly improved quality of life. IPXL plans to file its NDA in the fourth quarter of 2011 with the FDA.

These clinical updates are short summaries and should be used as a basis for further research. You should always perform your own due diligence. Many factors can determine whether a particular drug candidate will ever come to market or be profitable and biotech investing should be considered high risk.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.