UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Events. |
On May 2, 2025, Liquidia Corporation, a Delaware corporation (the “Company”), issued a press release announcing that the U.S. District Court for the District of Columbia dismissed, without prejudice, the cross-claim filed by United Therapeutics Corporation that sought to challenge Liquidia’s amendment to its New Drug Application (“NDA”) for YUTREPIA™ (treprostinil) inhalation powder, which added the treatment of pulmonary hypertension associated with interstitial lung disease to the proposed label for YUTREPIA. As previously disclosed on March 28, 2025, the FDA has accepted the Company’s NDA resubmission for YUTREPIA to treat pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease and has set a Prescription Drug User Fee Act (“PDUFA”) goal date of May 24, 2025.
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 May 2, 2025. | |
| 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.
| May 5, 2025 | Liquidia Corporation | |
| By: | /s/ Michael Kaseta | |
| Name: Michael Kaseta | ||
| Title: Chief Financial Officer and Chief Operating Officer | ||