FDA Accepts Liquidia's NDA Resubmission For Yutrepia, Sets PDUFA Date For May 2025

(RTTNews) - Liquidia Corp. (LQDA), a biopharmaceutical company focused on developing treatments for rare cardiopulmonary diseases, announced Friday that the U.S. Food and Drug Administration has accepted its New Drug Application or NDA resubmission for Yutrepia - treprostinil inhalation powder.

Yutrepia is intended for patients with pulmonary arterial hypertension, and pulmonary hypertension associated with interstitial lung disease. The company said FDA had confirmed that the resubmission is a complete, Class 1 response to the previous action letter dated August 16, 2024, which had granted tentative approval for the drug. The agency has set a Prescription Drug User Fee Act - PDUFA goal date of May 24, 2025.

Liquidia's Chief Executive Officer, Roger Jeffs, emphasized the company's commitment to collaborating with the FDA in the coming months to secure final approval and stated that preparations for the launch of Yutrepia will continue in the meantime.

LQDA is currently trading at $15.42 or 1.18% lower on the Nasdaq Capital Market.