Liquidia Corp Receives FDA Approval for Yutrepia™

By Ahmed Jameison • Sunday, May 25 17:26 • Permanent Link

Liquidia Corporation (NASDAQ: LQDA) has announced the approval of Yutrepia™ (treprostinil) inhalation powder by the U.S. Food and Drug Administration (FDA) for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). This approval marks a significant milestone for the company as it provides a new treatment option for patients with PAH and PH-ILD.

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, as well as those transitioning to Yutrepia from nebulized treprostinil. Results from the trial demonstrated the tolerability and titratability of Yutrepia.

Following the approval, Liquidia is preparing for the commercial launch of Yutrepia and will be hosting a webcast on May 27, 2025, to provide an update on commercial launch preparations.

The company also disclosed that United Therapeutics Corporation (UTHR) has filed a complaint alleging infringement of a U.S. patent and seeks to enjoin Liquidia from commercializing Yutrepia to treat PAH and PH-ILD.

Pulmonary arterial hypertension (PAH) is a rare, chronic, progressive disease that currently affects an estimated 45,000 patients in the United States, and there is currently no cure for PAH. Meanwhile, pulmonary hypertension associated with interstitial lung disease (PH-ILD) impacts a larger patient population, with the current estimate of prevalence in the United States being greater than 60,000 patients.

Yutrepia is an inhaled dry-powder formulation of treprostinil delivered through a convenient, low-effort, palm-sized device. It was designed using Liquidia’s Print® technology, which enables the development of drug particles that are precise and uniform in size, shape, and composition, and that are engineered for enhanced deposition in the lung following oral inhalation.

Following these announcements, the company's shares moved -1.35%, and are now trading at a price of $15.35. Check out the company's full 8-K submission here.

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