Liquidia Corporation Announces FDA Acceptance of New Drug Application Resubmission for YUTREPIA™ (treprostinil) Inhalation Powder

Core Viewpoint - Liquidia Corporation has received acceptance from the FDA for its New Drug Application resubmission for YUTREPIA™ (treprostinil) inhalation powder, aimed at treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) [1][2] Group 1: FDA Approval Process - The FDA confirmed that the resubmission was a complete, Class 1 response to the previous action letter issued on August 16, 2024, which granted tentative approval for YUTREPIA for both PAH and PH-ILD [1] - The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of May 24, 2025, for the final decision on the NDA [1] Group 2: Company Overview - Liquidia Corporation is focused on developing innovative therapies for patients with rare cardiopulmonary diseases, particularly in the area of pulmonary hypertension [2] - The company utilizes its proprietary PRINT® Technology to create its lead candidate, YUTREPIA™ (treprostinil) inhalation powder, which is an investigational drug for PAH and PH-ILD [2] - Liquidia is also developing L606, a sustained-release formulation of treprostinil, and currently markets generic Treprostinil Injection for PAH treatment [2]