Liquidia Corporation

09/17/2024 | Press release | Distributed by Public on 09/17/2024 15:16

Material Event Form 8 K

Item 8.01 Other Events.

As previously disclosed, on August 21, 2024, Liquidia Corporation, a Delaware corporation (the "Company") filed a lawsuit (the "FDA Suit") in the U.S. District Court of the District of Columbia (the "District Court") (Case No. 1:24-cv-02428) that challenged the recent decision by the U.S. Food and Drug Administration (the "FDA") to grant 3-year new clinical investigation exclusivity (NCI exclusivity) to Tyvaso DPI. As also previously disclosed, on August 20, 2024, United Therapeutics Corporation ("United Therapeutics") voluntarily dismissed, without prejudice, the complaint it had filed against the FDA in the District Court, challenging the FDA's acceptance of Liquidia's amended New Drug Application (the "NDA") for YUTREPIA (treprostinil) inhalation powder ("YUTREPIA") for review.

On September 16, 2024, United Therapeutics filed new cross-claims in the FDA Suit against the FDA, re-asserting its challenge to the FDA's acceptance of Liquidia's NDA for YUTREPIA. The Company intends to vigorously defend its ability to launch YUTREPIA and to defend itself against these allegations.