Lexeo Therapeutics (NASDAQ: LXEO) updates LX2006 path and interim FA data

Rhea-AI Filing Summary

Lexeo Therapeutics, Inc. reported regulatory updates and clinical progress for its gene therapy candidate LX2006 for Friedreich ataxia cardiomyopathy. The company received FDA feedback on key components of a potential accelerated approval pathway for LX2006 and highlighted positive interim Phase 1/2 clinical data in this indication. On October 7, 2025, Lexeo issued a press release detailing these developments and scheduled a conference call and webcast at 8:00 a.m. ET the same day to discuss the regulatory updates and interim data. The corporate presentation and press release are furnished as exhibits to provide more detail on the program and pathway.

Insights

Biotech and regulatory strategy analyst

Lexeo highlights FDA feedback and positive interim data for LX2006 in FA cardiomyopathy.

Lexeo Therapeutics reports regulatory updates tied to an accelerated approval pathway for LX2006, its therapy for Friedreich ataxia cardiomyopathy. The company states these updates are based on FDA feedback to date, which is important because accelerated approval can allow earlier market access if certain criteria are met. In parallel, Lexeo describes interim Phase 1/2 clinical data for LX2006 as positive, signaling early support for the therapy’s potential in this cardiac complication of FA.

The company also arranged a conference call and webcast on October 7, 2025 at 8:00 a.m. ET to discuss the regulatory updates and interim data. This suggests an intention to provide more detailed context around the FDA dialogue and the evolving clinical profile of LX2006. Future disclosures in company materials and subsequent filings will be needed to understand the robustness of the data, the specific elements of the accelerated approval pathway, and any next regulatory milestones.

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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): October 07, 2025

Lexeo Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware			001-41855	85-4012572
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
345 Park Avenue South, Floor 6
New York, New York				10010
(Address of Principal Executive Offices)				(Zip Code)

Registrant’s Telephone Number, Including Area Code: 212 547-9879

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:

☐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, $0.0001 par value per share		LXEO		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. ☐

Item 7.01 Regulation FD Disclosure.

The corporate presentation to be used in connection with the webcast described in Item 8.01 below is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated into this Item 7.01 by reference.

The information in this Item 7.01, including Exhibit 99.1 attached hereto, 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, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 8.01 Other Events.

On October 7, 2025, Lexeo Therapeutics, Inc. (the "Company") issued a press release announcing regulatory updates to key components of an accelerated approval pathway for LX2006 for the treatment of Friedreich ataxia (“FA”) cardiomyopathy based on FDA feedback to date, alongside positive interim Phase 1/2 clinical data for LX2006 for the treatment of FA cardiomyopathy. As part of the press release, the Company announced that it would be hosting a conference call and webcast at 8:00 a.m. ET on October 7, 2025 to discuss regulatory updates and interim Phase 1/2 clinical data of LX2006 for the treatment of FA cardiomyopathy. The press release is attached hereto as Exhibit 99.2 and incorporated by reference herein.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number		Description
99.1		Corporate Presentation, October 7, 2025, furnished herewith.
99.2		Press release issued by the Company on October 7, 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.

			Lexeo Therapeutics, Inc.
Date:	October 7, 2025	By:	/s/ R. Nolan Townsend
			R. Nolan Townsend, Chief Executive Officer

FAQ

What did Lexeo Therapeutics (LXEO) disclose about LX2006 in this 8-K?

Lexeo Therapeutics disclosed regulatory updates related to an accelerated approval pathway for LX2006, its therapy for Friedreich ataxia cardiomyopathy, based on FDA feedback to date, along with positive interim Phase 1/2 clinical data for LX2006 in the same indication.

What disease is Lexeo Therapeutics targeting with LX2006?

LX2006 is being developed for the treatment of Friedreich ataxia (FA) cardiomyopathy, a serious cardiac manifestation of Friedreich ataxia.

What regulatory progress did Lexeo report for LX2006?

Lexeo reported regulatory updates to key components of an accelerated approval pathway for LX2006, which are based on FDA feedback received to date regarding this program.

What clinical-stage information about LX2006 did Lexeo share?

The company highlighted positive interim Phase 1/2 clinical data for LX2006 in the treatment of Friedreich ataxia cardiomyopathy, indicating encouraging early clinical results from its ongoing study.

Did Lexeo Therapeutics schedule a call to discuss the LX2006 updates?

Yes. Lexeo announced it would host a conference call and webcast at 8:00 a.m. ET on October 7, 2025 to discuss the regulatory updates and interim Phase 1/2 data for LX2006.

Which exhibits related to LX2006 are included with this Lexeo 8-K?

The filing includes a corporate presentation dated October 7, 2025 as Exhibit 99.1 and a press release issued on October 7, 2025 as Exhibit 99.2, both addressing LX2006 regulatory and clinical updates.