Liquidia Corporation filed SEC Form 8-K: Other Events, Financial Statements and Exhibits
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| Item 8.01 | Other Events. |
On March 28, 2025, Liquidia Corporation, a Delaware corporation (the “Company”), issued a press release announcing that the U.S. Food and Drug Administration (the “FDA”) accepted its New Drug Application (“NDA”) resubmission for YUTREPIA™ (treprostinil) inhalation powder to treat pulmonary arterial hypertension (“PAH”) and pulmonary hypertension associated with interstitial lung disease (“PH-ILD”). The FDA confirmed that the resubmission was a complete, Class 1 response to the previous action letter issued on August 16, 2024, which granted tentative approval of YUTREPIA for both PAH and PH-ILD. The FDA 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 March 28, 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.
| March 28, 2025 | Liquidia Corporation | |
| By: | /s/ Michael Kaseta | |
| Name: Michael Kaseta | ||
| Title: Chief Financial Officer and Chief Operating Officer | ||