- The FDA has granted tentative approval to Liquidia Corporation's 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 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.
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