Liquidia announces FDA acceptance of NDA resubmission for YUTREPIA

Liquidia (LQDA) announced that the U.S. Food and Drug Administration has accepted its New Drug Application resubmission for YUTREPIA inhalation powder to treat pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. 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 of YUTREPIA for both PAH and PH-ILD. The FDA has set a Prescription Drug User Fee Act goal date of May 24, 2025.