Liquidia Corporation filed SEC Form 8-K: Other Events, Financial Statements and Exhibits
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Item 8.01 Other Events.
On August 22, 2024, Liquidia Corporation, a Delaware corporation (the “Company”) issued a press release announcing that (i) on August 21, 2024, the Company filed a lawsuit in the U.S. District Court of the District of Columbia (the “District Court”) (Case No. 1:24-cv-02428) that challenges 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 and (ii) on August 20, 2024, 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 for YUTREPIA (treprostinil) inhalation powder for review.
A copy of the press release is filed as Exhibit 99.1 hereto and is incorporated by reference into this Item 8.01.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. |
Exhibit | |
| 99.1 | Press Release of Liquidia Corporation, dated August 22, 2024. | |
| 104 | Cover Page Interactive Data File (the cover page tags are embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| August 22, 2024 | Liquidia Corporation | |
| By: | /s/ Michael Kaseta | |
| Name: Michael Kaseta | ||
| Title: Chief Financial Officer and Chief Operating Officer | ||