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Friday, May 23, 2025

Liquidia FDA OK for Pulmonary Arterial Hypertension, Interstitial Lung Disease

The FDA has approved Liquidia's (NASDAQ: LQDA) YUTREPIA™, a novel inhalation powder form of treprostinil for treating adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). YUTREPIA is the first prostacyclin dry-powder formulation using Liquidia's proprietary PRINT™ technology, designed for enhanced deep-lung delivery through a low-effort device. The approval is based on the successful Phase 3 INSPIRE trial, which demonstrated safety and tolerability in both treprostinil-naïve patients and those transitioning from nebulized treprostinil. However, United Therapeutics (UTHR) has filed a patent infringement complaint and seeks to block YUTREPIA's commercial launch through a temporary restraining order and preliminary injunction, with the motion currently pending.

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