[8-K] Celcuity Inc. Reports Material Event

Rhea-AI Filing Summary

Celcuity Inc. (CELC) reported that it has submitted a New Drug Application to the U.S. Food and Drug Administration for gedatolisib as a treatment for hormone receptor positive, HER2-negative, PIK3CA wild-type advanced breast cancer. This step means the company is formally asking the FDA to review gedatolisib for potential approval in this breast cancer setting. The submission focuses on patients whose tumors are HR+/HER2- and PIK3CA wild-type, a defined subset of advanced breast cancer. Celcuity disclosed this news through a press release that is furnished as an exhibit to the report.

Positive

• NDA submission for gedatolisib in HR+/HER2-, PIK3CA wild-type advanced breast cancer marks a major regulatory milestone that could lead to a potential commercial therapy if approved.

Negative

• None.

Insights

Biopharma regulatory analyst

Celcuity advances gedatolisib by submitting an NDA for a breast cancer indication.

Celcuity reports that it has submitted a New Drug Application to the FDA for gedatolisib in hormone receptor positive, HER2-negative, PIK3CA wild-type advanced breast cancer. An NDA is the formal request for FDA review to market a new drug, so this represents a key regulatory milestone for the program. The filing centers on a defined patient group within advanced breast cancer, which can help target the intended use.

The announcement does not describe the supporting clinical data or expected review timelines, but it confirms that Celcuity believes the dataset is sufficient to seek approval. If the NDA is accepted for review and ultimately approved, gedatolisib could become a commercial product candidate in this indication. Further details on review status, potential labeling, and any FDA feedback would typically come in later company communications.

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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): November 17, 2025

Celcuity Inc.

(Exact name of Registrant as Specified in its Charter)

Delaware		001-38207		82-2863566
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

16305 36th Avenue North, Suite 100
Minneapolis, Minnesota 55446

(Address of Principal Executive Offices and Zip Code)

(763) 392-0767

(Registrant’s telephone number, including area code)

Not Applicable

(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:

☐	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, $0.001 par value per share		CELC		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 7.01 Regulation FD Disclosure.

On November 17, 2025, Celcuity Inc. (the “Company”) issued a press release announcing the submission of its New Drug Application (“NDA”) to the U.S. Food and Drug Administration (the “FDA”) for gedatolisib in hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), PIK3CA wild-type advanced breast cancer (“ABC”). A copy of this press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.

The information in this Item 7.01, including the accompanying exhibit, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. The information in this Item 7.01 shall not be incorporated into any filing pursuant to the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.

Item 8.01 Other Events.

On November 17, 2025, the Company issued a press release announcing the submission of its NDA to the FDA for gedatolisib in HR+/HER2- PIK3CA wild-type ABC.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

99.1	Press release dated November 17, 2025
104	Cover Page Interactive Data File (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.

Date: November 17, 2025

CELCUITY INC.
By:	/s/ Brian F. Sullivan
	Brian F. Sullivan
	Chief Executive Officer

FAQ

What did Celcuity Inc. (CELC) announce in this 8-K filing?

Celcuity announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for its drug candidate gedatolisib in a specific type of advanced breast cancer.

For which indication is Celcuity seeking FDA approval for gedatolisib?

The NDA submission is for gedatolisib to treat hormone receptor positive (HR+), HER2-negative, PIK3CA wild-type advanced breast cancer.

Does this 8-K mean gedatolisib has been approved by the FDA?

No. The 8-K states that Celcuity has submitted an NDA to the FDA. This begins the formal review process but does not indicate that the drug has been approved.

How did Celcuity communicate the NDA submission to the market?

Celcuity issued a press release on November 17, 2025, announcing the NDA submission, which is furnished as Exhibit 99.1 to the report.

What type of SEC filing did Celcuity use to disclose the NDA submission?

Celcuity used a Form 8-K to disclose the NDA submission to the FDA for gedatolisib.

Is the information about the NDA submission considered filed or furnished?

The company states that the information in this item, including the press release, is being furnished and not deemed filed for purposes of Section 18 of the Exchange Act.