Liquidia Corporation filed SEC Form 8-K: Other Events, Financial Statements and Exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
| (Exact name of registrant as specified in its charter) | ||
|
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
| (Address of principal executive offices) | (Zip Code) | |
Registrant’s telephone number, including
area code: (
| (Former name or former address, if changed since last report.) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| The |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
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.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. |
Exhibit | |
| 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.
| September 17, 2024 | Liquidia Corporation | ||
| By: | /s/ Michael Kaseta | ||
| Name: | Michael Kaseta | ||
| Title: | Chief Financial Officer and Chief Operating Officer | ||