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Liquidia Corporation Reports Full Year 2023 Financial Results and Provides Corporate Update
Preparing to launch YUTREPIA™ (treprostinil) inhalation powder upon final FDA approvalFederal Circuit rejected request by United Therapeutics for rehearing of
About this update from Liquidia Corporation
[{"type":"text","content":"Preparing to launch YUTREPIA™ (treprostinil) inhalation powder upon final FDA approvalFederal Circuit rejected request by United Therapeutics for rehearing of earlier decision finding ‘793 Patent invalidAdvancing industry leading portfolio for inhaled treprostinil with YUTREPIA and sustained-release program L606Company to host webcast today at 8:30 a.m. ET MORRISVILLE, N.C., March 13, 2024 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company) today reported financial results for the full year ended December 31, 2023. The Company will host a webcast at 8:30 a.m. ET to discuss the 2023 financial results and provide a corporate update. Roger Jeffs, Liquidia’s Chief Executive Officer, said: “Based on our success last year, we are preparing to become a full-scale commercial entity in 2024 and initiate meaningful change to the lives of patients diagnosed with PAH and PH-ILD. Given recent favorable court decisions, we have positioned the Company to be ready for launch of YUTREPIA in both indications following the expiration of Tyvaso’s market exclusivity on March 31, 2024. Once on the market, we are confident that the medical community will see first-hand that YUTREPIA has the potential to not only be the best-in-class inhaled product, but also the prostacyclin of first choice given its convenient, low-effort delivery and wide dosing range enabled by our proprietary PRINT Technology.” Corporate Updates Invalidity of sole patent supporting injunction was affirmed in appeal proceedings at the Federal Circuit. In December 2023, the previous ruling by the Patent Trial and Appeal Board (PTAB) that all of the claims in U.S. Patent No. 10,716,793 (‘793 Patent) are invalid was affirmed by the U.S. Court of Appeals for the Federal Circuit (Federal Circuit). On March 12, 2024, the Federal Circuit rejected United Therapeutics’ request for a rehearing of the ruling in December. Liquidia has submitted these Federal Circuit rulings to Judge Andrews and requested that he set aside the injunction preventing final regulatory approval of YUTREPIA that he entered in 2022, which is based solely on the ‘793 Patent. Awaiting final FDA approval of YUTREPIA to treat PAH and PH-ILD after March 31, 2024. In September 2023, the U.S. Food and Drug Administration (FDA) accepted for review the Company’s amendment to the tentatively appro...