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): November 15, 2019

LIQUIDIA TECHNOLOGIES, INC.

(Exact name of registrant as specified in its charter)

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):

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

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

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

o 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:

Indicate by check mark whether the registrant is an emerging growth company as defined in 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 x

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. x

Item 8.01                                           Other Events.

As previously disclosed, Liquidia Technologies, a Delaware corporation (the “Company”), anticipated a pre-New Drug Application (NDA) submission meeting in the fourth quarter of 2019 with the U.S. Food and Drug Administration (the “FDA”) to discuss the nonclinical and clinical contents of the planned NDA for LIQ861. On November 15, 2019, the Company received written correspondence from the FDA in response to the Company’s pre-NDA submission questions.  Given that the Company deemed the written responses provided by the FDA to sufficiently answer its pre-submission questions and that the FDA did not provide the Company with any unanticipated requirements for the NDA submission, the Company now believes that a pre-NDA submission meeting is no longer necessary.

The Company continues to target a first quarter 2020 NDA submission for LIQ861.  However, there can be no assurances that the FDA will accept the NDA for filing once submitted or, if accepted for filing and subject to substantive review by the FDA, that the FDA will ultimately approve LIQ861.

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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.

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