Auriga Downgrades United Therapeutics Corp. (UTHR) to Hold; FREEDOM-C2 Fails To Hit Primary Endpoint

Auriga downgraded United Therapeutics Corp. (NASDAQ: UTHR) from Buy to Hold, price target cut in half to $45.00.

Auriga analyst says, "UTHR reported results from the FREEDOM-C2 trial, which tested an oral formulation of Remodulin in combination with two other approved Pulmonary Arterial Hypertension (PAH) agents. The results failed to reach statistical significance (p=0.089) on the primary endpoint. Additionally, the trial missed on several key secondary endpoints as well (p > 0.05). UTHR noted that despite being on stable doses of active agents (for two plus years), the placebo arm improved 11 meters versus 15 meters in the combo arm, thus creating a high efficacy hurdle. Given the results, UTHR plans to file an NDA in 1Q12 as a monotherapy using the prior FREEDOM-M results. That said, FDA approval is not without challenges. While UTHR's core franchise appears steady, the oral Remodulin combination failure complicates UTHR's regulatory and commercial outlook and removes most of the long term upside potential (2013 and beyond)."

For more ratings news on United Therapeutics Corp. click here and for the rating history of United Therapeutics Corp. click here.

Shares of United Therapeutics Corp. closed at $39.91 yesterday.

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