Neurogene (NGNE) shares positive Phase 1/2 NGN-401 Rett data

Neurogene Inc. (NGNE) furnished an Item 7.01 update announcing positive, updated interim clinical data from the pediatric (ages 4–10) cohort of its ongoing Phase 1/2 trial of NGN-401 gene therapy for females with Rett syndrome.

Accepted by SEC EDGAR 11/12/2025 - 05:11 PM EST Learn about SEC filing dates

Rhea-AI Filing Summary

Neurogene Inc. (NGNE) furnished an Item 7.01 update announcing positive, updated interim clinical data from the pediatric (ages 4–10) cohort of its ongoing Phase 1/2 trial of NGN-401 gene therapy for females with Rett syndrome. The company also posted a related corporate presentation. A press release (Exhibit 99.1) and the presentation (Exhibit 99.2) were furnished, not filed, on November 12, 2025.

8-K Event Classification

Item 7.01 — Regulation FD Disclosure

1 item

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did NGNE announce in its 8-K?

Neurogene furnished positive, updated interim data from the pediatric cohort of its Phase 1/2 NGN-401 trial for females with Rett syndrome.

Which patient group was highlighted by NGNE (NGNE)?

The pediatric cohort ages 4–10 in an ongoing Phase 1/2 study.

What is NGN-401 in the NGNE filing?

NGN-401 is a gene therapy being evaluated for females with Rett syndrome.

When were the NGNE updates made public?

November 12, 2025.

What exhibits accompany NGNE’s disclosure?

Exhibit 99.1 is the press release; Exhibit 99.2 is the corporate presentation.

Is the information considered filed with the SEC?

No. The Item 7.01 information and Exhibits 99.1 and 99.2 were furnished and are not deemed filed under Section 18.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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0001404644FALSE00014046442024-03-182024-03-18

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 12, 2025

Neurogene Inc.

(Exact name of registrant as specified in its charter)

Delaware			001-36327			98-0542593
(State or other jurisdiction of incorporation or organization)			(Commission File Number)			(I.R.S. Employer Identification No.)

535 W 24th Street, 5th Floor

New York, NY 10011

(Address of principal executive offices, including zip code)

Registrant's telephone number, including area code: (877) 237-5020

N/A

(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, $0.000001 par value

NGNE

The Nasdaq Global Market

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. o

Item 7.01 Regulation FD Disclosure

On November 12, 2025, Neurogene Inc. (the “Company”) issued a press release announcing positive, updated interim clinical data in the pediatric cohort (ages 4-10 cohort) from its ongoing Phase 1/2 trial evaluating NGN-401 gene therapy for the treatment of females with Rett syndrome. A copy of the press release announcing such results is attached as Exhibit 99.1 to this Current Report on Form 8-K.

On November 12, 2025, the Company also made available on its website a corporate presentation regarding the clinical data described in the press release referenced above. A copy of the presentation is furnished as Exhibit 99.2 to this Current Report on Form 8-K.

The information in this Item 7.01 and Exhibits 99.1 and 99.2 attached hereto are being furnished and shall not be deemed “filed” for the 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, nor shall such information or Exhibits 99.1 and 99.2 be deemed incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933, as amended, except as expressly set forth by specific reference to such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number						Description
99.1						Press Release dated November 12, 2025
99.2						Corporate Presentation (November 12, 2025)
104						Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

			NEUROGENE INC.
Date: November 12, 2025			By:			/s/ Christine Mikail
						Name: Christine Mikail
						Title: President, Chief Financial Officer