Neurogene (NGNE) doses first patient in NGN-401 Rett trial

Neurogene Inc. (NGNE) reported a clinical milestone: the first patient has been dosed in the Embolden registrational trial of NGN-401 for Rett syndrome.

Accepted by SEC EDGAR 11/06/2025 - 07:31 AM EST Learn about SEC filing dates

Rhea-AI Filing Summary

Neurogene Inc. (NGNE) reported a clinical milestone: the first patient has been dosed in the Embolden registrational trial of NGN-401 for Rett syndrome. The company furnished a press release and an updated corporate presentation highlighting ongoing enrollment and dosing activity.

The materials were provided as Exhibit 99.1 (press release) and Exhibit 99.2 (corporate presentation). The information was furnished under Item 7.01 and is not deemed “filed” for purposes of Section 18 of the Exchange Act or incorporated by reference, except as specifically referenced.

Insights

Biotech clinical development analyst

Administrative 8-K furnishing a clinical dosing milestone; neutral impact.

Neurogene announced first-patient dosing in the Embolden registrational trial of NGN-401 for Rett syndrome, a key step in advancing a late-stage study. The company also furnished a press release and corporate presentation on November 6, 2025.

The disclosure is informational under Item 7.01, indicating progress but without clinical data, timelines, or financial terms in the excerpt. Actual impact will depend on future trial updates and outcomes.

The exhibits (99.1, 99.2) outline the milestone and ongoing enrollment and dosing. Subsequent filings may provide efficacy, safety, or operational details as the registrational program proceeds.

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 Neurogene (NGNE) disclose in this 8-K?

Neurogene announced dosing of the first patient in the Embolden registrational trial of NGN-401 for Rett syndrome and furnished related materials.

Which exhibits were furnished by NGNE?

The company furnished Exhibit 99.1 (press release) and Exhibit 99.2 (corporate presentation).

Under which item was the NGNE information provided?

The information was furnished under Item 7.01 (Regulation FD Disclosure).

Is the NGNE information considered "filed" under the Exchange Act?

No. It was furnished and is not deemed “filed” for Section 18 liability or incorporated by reference, except if specifically referenced.

What program is NGN-401 being studied in?

NGN-401 is being studied in the Embolden registrational trial for Rett syndrome.

When were the materials made available?

On November 6, 2025, Neurogene issued the press release and posted the updated corporate presentation.

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 6, 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 6, 2025, Neurogene Inc. (the “Company”) issued a press release announcing the dosing of the first patient in the EmboldenTM registrational trial of NGN-401 for the treatment of 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 6, 2025, the Company also made available on its website an updated corporate presentation including the information regarding the ongoing enrollment and dosing in the Embolden trial. A copy of the corporate 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 6, 2025
99.2						Corporate Presentation (November 6, 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 6, 2025			By:			/s/ Christine Mikail
						Name: Christine Mikail
						Title: President, Chief Financial Officer