false 0001819576 0001819576 2024-09-16 2024-09-16 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): September 16, 2024

 

LIQUIDIA CORPORATION
(Exact name of registrant as specified in its charter)
     
Delaware 001-39724 85-1710962

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

     
419 Davis Drive, Suite 100, Morrisville, North Carolina 27560
(Address of principal executive offices) (Zip Code)

  

Registrant’s telephone number, including area code: (919) 328-4400

(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):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class Trading Symbol(s) Name of each exchange on which registered
Common stock LQDA The Nasdaq Stock Market LLC

 

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

 

 

 

v3.24.3
Cover
Sep. 16, 2024
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Sep. 16, 2024
Entity File Number 001-39724
Entity Registrant Name LIQUIDIA CORPORATION
Entity Central Index Key 0001819576
Entity Tax Identification Number 85-1710962
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 419 Davis Drive
Entity Address, Address Line Two Suite 100
Entity Address, City or Town Morrisville
Entity Address, State or Province NC
Entity Address, Postal Zip Code 27560
City Area Code 919
Local Phone Number 328-4400
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common stock
Trading Symbol LQDA
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
Liquidia (NASDAQ:LQDA)
Historical Stock Chart
From Oct 2024 to Nov 2024 Click Here for more Liquidia Charts.
Liquidia (NASDAQ:LQDA)
Historical Stock Chart
From Nov 2023 to Nov 2024 Click Here for more Liquidia Charts.