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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): May 2, 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 May 2, 2025, Liquidia Corporation, a Delaware corporation (the “Company”), issued a press release announcing that the U.S. District Court for the District of Columbia dismissed, without prejudice, the cross-claim filed by United Therapeutics Corporation that sought to challenge Liquidia’s amendment to its New Drug Application (“NDA”) for YUTREPIA™ (treprostinil) inhalation powder, which added the treatment of pulmonary hypertension associated with interstitial lung disease to the proposed label for YUTREPIA. As previously disclosed on March 28, 2025, the FDA has accepted the Company’s NDA resubmission for YUTREPIA to treat pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease and 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 May 2, 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.
| May 5, 2025 | Liquidia Corporation | |
| By: | /s/ Michael Kaseta | |
| Name: Michael Kaseta | ||
| Title: Chief Financial Officer and Chief Operating Officer | ||
Exhibit 99.1
District Court Dismisses Dispute Filed by United Therapeutics Against Liquidia
| · | Court will not hear cross-claim that challenges the PH-ILD indication in the tentatively approved NDA for YUTREPIA |
| · | FDA can grant final approval of YUTREPIA after blocking regulatory exclusivity expires on May 23, 2025 |
MORRISVILLE, N.C., May 2, 2025 – Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease, today announced that Judge Kelly of the U.S. District Court for the District of Columbia (District Court) dismissed, without prejudice, the cross-claim filed by United Therapeutics (UTHR) that sought to challenge Liquidia’s amendment to its New Drug Application (NDA) for YUTREPIA™ (treprostinil) inhalation powder, which added the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) to the proposed label for YUTREPIA. In its ruling, the District Court determined that UTHR’s claim was unripe and that UTHR had failed to plausibly allege that it has standing.
Dr. Roger Jeffs, CEO, Liquidia said: “We are pleased with the court’s decision to dismiss this cross-claim, specifically holding that UTHR failed to establish standing. We also continue to believe that the FDA was correct to accept, and subsequently tentatively approve, our amended NDA for YUTREPIA to include the PH-ILD indication. We remain laser focused on the potential final approval of YUTREPIA following the expiration of gating regulatory exclusivity on May 23, 2025, and look forward to delivering what we believe will become the prostacyclin of first choice for patients with PAH and PH-ILD and the physicians who treat them.”
UTHR has the right to appeal the Court’s ruling.
The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date for the YUTREPIA NDA of May 24, 2025.
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, the timeline or outcome of the cross-claims that United Therapeutics has brought against the FDA, the timeline or
outcome related to patent litigation in the U.S. District Court for the District of Delaware, 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, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied
herein. The decisions of courts or other tribunals are not determinative of the outcome of the appeals or rehearings of
the decisions. 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