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): March 28, 2025
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. |
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 |
Exhibit 99.1
Liquidia Corporation Announces FDA Acceptance of New Drug Application Resubmission for YUTREPIA™ (treprostinil) Inhalation Powder
· | FDA sets PDUFA goal date of May 24, 2025 |
MORRISVILLE, N.C., March 28, 2025 – Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease, today announced that the U.S. Food and Drug Administration (FDA) has 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.
Dr. Roger Jeffs, Ph.D., Chief Executive Officer of Liquidia, said: “We are pleased that the FDA has responded promptly to the resubmission that we filed on Monday. We look forward to working with the FDA over the coming months as we seek final approval for YUTREPIA and, in the meantime, will continue preparations to support a launch of YUTREPIA as soon as possible.”
About Liquidia Corporation
Liquidia Corporation is a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease. The company’s current focus spans the development and commercialization of products in pulmonary hypertension and other applications of its proprietary PRINT® Technology. PRINT enabled the creation of Liquidia’s lead candidate, YUTREPIA™ (treprostinil) inhalation powder, an investigational drug for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The company is also developing L606, an investigational sustained-release formulation of treprostinil administered twice-daily with a next-generation nebulizer, and currently markets generic Treprostinil Injection for the treatment of PAH. To learn more about Liquidia, please visit www.liquidia.com.
Cautionary Statements Regarding Forward-Looking Statements
This press release may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
All statements contained in this press release other than statements of historical facts, including statements regarding our future results
of operations and financial position, our strategic and financial initiatives, our business strategy and plans and our objectives for
future operations, are forward-looking statements. Such forward-looking statements, including statements regarding clinical trials, clinical
studies and other clinical work (including the funding therefor, anticipated patient enrollment, safety data, study data, trial outcomes,
timing or associated costs), regulatory applications and related submission contents and timelines, including the potential for final
FDA approval of the NDA for YUTREPIA, which may occur after the expiration of the exclusivity period of TYVASO DPI, if at all, the timelines
or outcomes related to patent litigation with United Therapeutics in the U.S. District Court for the District of Delaware, litigation
with United Therapeutics and FDA in the U.S. District Court for the District of Columbia or other litigation instituted by United
Therapeutics or others, including rehearings or appeals of decisions in any such proceedings, the issuance of patents by the USPTO and
our ability to execute on our strategic or financial initiatives, our estimates regarding future expenses, capital requirements and needs
for additional financing, and potential revenue and profitability of YUTREPIA, if approved, involve significant risks and uncertainties
and actual results could differ materially from those expressed or implied herein. The FDA’s final action of the NDA for YUTREPIA
could be delayed beyond the assigned PDUFA date. The words “anticipate,” “believe,” “continue,” “could,”
“estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,”
“project,” “should,” “target,” “would,” and similar expressions are intended to identify
forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future
events and financial trends that we believe may affect our financial condition, results of operations, business strategy, short-term and
long-term business operations and objectives and financial needs. These forward-looking statements are subject to a number of risks discussed
in our filings with the SEC, as well as a number of uncertainties and assumptions. Moreover, we operate in a very competitive and
rapidly changing environment and our industry has inherent risks. New risks emerge from time to time. It is not possible for our management
to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of
factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of
these risks, uncertainties and assumptions, the future events discussed in this press release may not occur and actual results could differ
materially and adversely from those anticipated or implied in the forward-looking statements. Nothing in this press release should be
regarded as a representation by any person that these goals will be achieved, and we undertake no duty to update our goals or to update
or alter any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact Information
Investors:
Jason Adair
Chief Business Officer
919.328.4350
jason.adair@liquidia.com
Media:
Patrick Wallace
Director, Corporate Communications
919.328.4383
patrick.wallace@liquidia.com