Liquidia Scores FDA Nod For Lung Disease Drug Yutrepia, Faces Legal Challenge

On Friday, the U.S. Food and Drug Administration (FDA) approved Liquidia Corporation’s LQDA Yutrepia (treprostinil) inhalation powder, a prostacyclin analog for adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise ability.

In August 2024, the FDA issued tentative approval of Yutrepia for the PAH and PH-ILD indications.

Also Read: FDA Battles Backlog of Drug Factory Inspections Since COVID-19

Yutrepia is the first and only prostacyclin dry-powder formulation enabled by Liquidia’s proprietary PRINT technology, which yields uniform, free-flowing particles designed to enhance deep-lung delivery via an easy-to-use, low-effort device requiring less inspiratory effort.

The approval of Yutrepia is based on findings from the Phase 3 INSPIRE trial, which evaluated patients who were naïve to treprostinil and those transitioning to Yutrepia from nebulized treprostinil.

Yutrepia was shown to be safe and well-tolerated regardless of a patient’s previous exposure to treprostinil.

As previously disclosed, United Therapeutics Corporation UTHR filed a complaint on May 9, in the U.S. District Court for the Middle District of North Carolina against Liquidia, alleging infringement of U.S. Patent No. 11,357,782. The complaint seeks to enjoin Liquidia from commercializing Yutrepia to treat PAH and PH-ILD.

United Therapeutics has filed a motion for a temporary restraining order and preliminary injunction to block Liquidia from commercially launching Yutrepia. An oral argument on the motion was held on May 20, 2025. The motion remains pending with the Court.

In March, Liquidia entered into a sixth amendment to its agreement with HealthCare Royalty to provide up to an additional $100 million of financing in three tranches. 

The company intends to use the proceeds to fund ongoing commercial development of Yutrepia, continued development of Yutrepia in other clinical trials, including but not limited to trials for pediatric patients, and trials further evaluating the use of Yutrepia in PAH and PH-ILD patients, clinical development of L606, a sustained-release formulation of treprostinil administered twice-daily with a next-generation nebulizer, and for general corporate purposes.

Price Action: LQDA stock is down 3.3% at $14.84 on the last check Tuesday.

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