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Liquidia Corporation Reports First Quarter 2025 Financial Results and Provides Corporate Update
Awaiting FDA action on YUTREPIA™ NDA with a PDUFA goal date of May 24, 2025District Court dismissed cross claim filed by United Therapeutics challenging
About this update from Liquidia Corporation
[{"type":"text","content":"Awaiting FDA action on YUTREPIA™ NDA with a PDUFA goal date of May 24, 2025District Court dismissed cross claim filed by United Therapeutics challenging PH-ILD amendmentFully enrolled Cohort A of ASCENT study in patients with PH-ILDFurther strengthened financial position via access of up to $100 million from existing financing agreement with HealthCare RoyaltyCompany to host webcast today at 8:30 a.m. ET MORRISVILLE, N.C., May 08, 2025 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease, today reported financial results for the first quarter ended March 31, 2025. The company will also host a webcast at 8:30 a.m. ET on May 8, 2025 to discuss its financial results and provide a corporate update. Dr. Roger Jeffs, Liquidia’s Chief Executive Officer, said: “With the FDA’s PDUFA goal date on the YUTREPIA NDA just over two weeks away, we remain focused on ensuring that we are prepared to make YUTREPIA commercially available in the quickest time possible if granted full approval. We continue to believe that YUTREPIA has the potential to be the prostacyclin of first choice for patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).” Corporate Updates Awaiting FDA action on NDA for YUTREPIA (treprostinil) inhalation powder On March 28, 2025, the U.S. Food and Drug Administration (FDA) accepted Liquidia’s New Drug Application (NDA) resubmission for YUTREPIA (treprostinil) inhalation powder to treat PAH and PH-ILD as a complete Class 1 response to the previous action letter issued on August 16, 2024, which granted tentative approval of YUTREPIA. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of May 24, 2025, the day after regulatory exclusivity expires for Tyvaso DPI®. Court will not hear cross-claim that challenged the amendment to the YUTREPIA NDA to add the PH-ILD indication On May 2, 2025, Liquidia announced that the U.S. District Court for the District of Columbia (District Court) dismissed, without prejudice, the cross-claim filed by United Therapeutics (UTHR) that sought to challenge Liquidia’s amendment to its NDA for YUTREPIA™ (treprostinil) inhalation powder, which added the treatment of PH-ILD)to the proposed label for YUTREPI...