Wedbush Maintains Outperform on United Therapeutics Ahead of FDA Vote

Wedbush Securities has published a research report on United Therapeutics

after the company received approval for IV Remodulin as treatment in the EU. In the report, Wedbush Securities writes, "We estimate potential acceptance of filing by the FDA by February 27, 2012, which would lead to a potential PDUFA deadline of October 27, 2012. Although we view regulatory risk as high due to the failure of the combination studies and that the p-value for FREEDOM-m was just over 0.01 (0.0125) instead of less than or equal to 0.01, we feel it is not impossible. Thus, we give approval a 50:50 chance as we understand a single successful pivotal trial can be sufficient for 505(b)(2) regulatory approval. If approved, we estimate peak US sales could reach about $203MM in 2016, assuming launch in December 2012." Wedbush Securities maintains its Outperform rating and has raised the price target/fair value estimate from $87 to $91 on United Therapeutics, which is currently trading down $0.35 from Friday's $46.56 closing price.