Liquidia Corporation (NASDAQ: LQDA) has just received approval from the U.S. Food and Drug Administration (FDA) for Yutrepia™ (treprostinil) inhalation powder, a prostacyclin analog. This medication is indicated for adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise ability. Yutrepia is the first and only prostacyclin dry-powder formulation enabled by Liquidia’s proprietary Print™ technology.
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. It was demonstrated to be safe and well-tolerated regardless of a patient’s previous exposure to treprostinil. The results from the INSPIRE study were published in the Pulmonary Circulation Journal in 2022 and the Vascular Pharmacology Journal in 2021.
Yutrepia is designed to enhance deep-lung delivery with an easy-to-use device requiring low inspiratory effort. It has demonstrated tolerability and titratability in the pivotal INSPIRE study. Liquidia aims to bring meaningful change to the lives of patients in need with the launch of Yutrepia.
The medication is an inhaled dry-powder formulation of treprostinil delivered through a convenient, low-effort, palm-sized device. Liquidia’s Print® technology enables the development of drug particles that are precise and uniform in size, shape, and composition, engineered for enhanced deposition in the lung following oral inhalation.
Liquidia is also currently developing L606, an investigational sustained-release formulation of treprostinil administered twice-daily with a next-generation nebulizer and markets generic treprostinil injection for the treatment of PAH. Liquidia’s president and CEO, Matt Granato, emphasized the importance of industry research leading to the development of drugs that expand options for the patient community.
The company will host a webcast on Tuesday, May 27, 2025, at 8:30 a.m. ET to provide an update on commercial launch preparations for Yutrepia. The webcast will be available on the “Investors” page of Liquidia’s website.
It's worth noting that United Therapeutics Corporation (UTHR) has filed a complaint against Liquidia alleging infringement of a U.S. patent and seeks to enjoin Liquidia from commercializing Yutrepia to treat PAH and PH-ILD. The motion remains pending with the court.
Liquidia Corporation is a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease. The company’s current focus spans the development and commercialization of products in pulmonary hypertension and other applications of its proprietary Print® technology. The market has reacted to these announcements by moving the company's shares -1.35% to a price of $15.35. Check out the company's full 8-K submission here.
