United Therapeutics to acquire priority review voucher for $105M

 

• United Therapeutics (NASDAQ:UTHR) inks agreement to purchase a Rare Pediatric Disease Priority Review Voucher (PRV) for $105M to use with a forthcoming New Drug Application (NDA) for Tyvaso DPI, expected in H1 2021.
• The PRV entitles the holder to designate an NDA for priority review and provides for an expedited eight-month review, instead of twelve-months.
• Tysavo (treprostinil) is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability.
• Also, the FDA is currently reviewing a supplement to the Tyvaso NDA to expand its labelling to include pulmonary hypertension associated with interstitial lung disease.
• UTHR has rallied 64% over the past year.
• United Therapeutics is developing Tyvaso DPI under a collaboration and license agreement with MannKind (NASDAQ:MNKD).
• https://seekingalpha.com/news/3647459-united-therapeutics-to-acquire-priority-review-voucher-for-105m