Benzinga | Nov 8, 2021 10:12AM EST

Liquidia's Inhaled Treprostinil Powder Scores Tentative FDA Approval For PAH

* The FDA has granted tentative approval to Liquidia Corporation's (NASDAQ:LQDA) Yutrepia (treprostinil) inhalation powder for pulmonary arterial hypertension (PAH) to improve exercise ability in adult patients with New York Heart Association (NYHA) Functional Class II-III symptoms.

* Tentative approval indicates that Yutrepia has met all regulatory standards for quality, safety, and efficacy required for approval in the U.S.

* Due to a regulatory stay according to the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act), Yutrepia cannot yet be marketed in the U.S.

* In June 2020, United Therapeutics Corp (NASDAQ:UTHR) filed a lawsuit against Liquidia for alleged infringement of three patents related to Tyvaso (treprostinil).

* As a result, the FDA cannot give final approval of YUTREPIA until the expiration of the regulatory stay on October 27, 2022, or earlier resolution or settlement of the ongoing litigation.

* Related content: Benzinga's Full FDA Calendar.

* Price Action: LQDA shares are up 0.17% at $4.14 during the market session on the last check Monday.