FDA Breakthrough Therapy for TSHA-102 in Rett at Taysha (NASDAQ: TSHA)

Rhea-AI Filing Summary

Taysha Gene Therapies, Inc. reported that it issued a press release titled “Taysha Gene Therapies Announces FDA Breakthrough Therapy Designation and Provides Positive Regulatory Update on TSHA-102 in Rett Syndrome.” The company states that the U.S. Food and Drug Administration granted Breakthrough Therapy designation for TSHA-102, its investigational therapy for Rett syndrome, and that it has received a positive regulatory update on this program. The full details are provided in the press release attached as Exhibit 99.1.

Positive

• FDA Breakthrough Therapy designation for TSHA-102 in Rett syndrome represents a major regulatory milestone for Taysha’s lead gene therapy program and signals encouraging agency feedback.

Negative

• None.

Insights

Biotech and FDA regulatory analyst

FDA Breakthrough Therapy designation for TSHA-102 is a major regulatory milestone for Taysha’s Rett syndrome program.

Taysha Gene Therapies disclosed that the FDA granted Breakthrough Therapy designation to TSHA-102 for Rett syndrome and referenced a positive regulatory update. Breakthrough Therapy is typically reserved for products that address serious conditions, so being placed in this category signals that regulators see potential in the therapy based on the existing data.

This type of designation often reflects closer regulatory engagement and heightened focus on a program, which can be important for a company centered on a few key assets. The reference to a positive regulatory update on TSHA-102 further underscores that interactions with the agency have been constructive for this Rett syndrome program.

Future company communications and subsequent filings that elaborate on the Breakthrough Therapy designation and the regulatory path for TSHA-102 in Rett syndrome will help clarify development plans and any timeline expectations that may emerge from these FDA interactions.

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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 2, 2025

Taysha Gene Therapies, Inc.

(Exact name of registrant as specified in its Charter)

Delaware		001-39536		84-3199512
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

3000 Pegasus Park Drive, Suite 1430 Dallas, Texas		75247
(Address of Principal Executive Offices)		(Zip Code)

(214) 612-0000

(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, $0.00001 par value		TSHA		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 October 2, 2025, Taysha Gene Therapies, Inc. issued a press release entitled “Taysha Gene Therapies Announces FDA Breakthrough Therapy Designation and Provides Positive Regulatory Update on TSHA-102 in Rett Syndrome.” The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		Press Release, dated October 2, 2025.
104		Cover Page Interactive Data File (the cover page XBRL 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.

						Taysha Gene Therapies, Inc.
				By:		/s/ Kamran Alam
Date: October 2, 2025						Kamran Alam
						Chief Financial Officer

FAQ

What did Taysha Gene Therapies (TSHA) announce in this filing?

Taysha Gene Therapies reported that it issued a press release titled “Taysha Gene Therapies Announces FDA Breakthrough Therapy Designation and Provides Positive Regulatory Update on TSHA-102 in Rett Syndrome,” and attached the full text as Exhibit 99.1.

Which Taysha Gene Therapies program received FDA Breakthrough Therapy designation?

The filing states that the FDA granted Breakthrough Therapy designation to TSHA-102, which is being developed for the treatment of Rett syndrome.

What condition is TSHA-102 targeting for Taysha Gene Therapies (TSHA)?

According to the report, TSHA-102 is an investigational therapy being developed by Taysha Gene Therapies for Rett syndrome.

How did Taysha Gene Therapies describe the regulatory status of TSHA-102?

The company referenced an FDA Breakthrough Therapy designation for TSHA-102 and noted a positive regulatory update on this Rett syndrome program in the title of the attached press release.

Where can investors find more details on Taysha’s TSHA-102 regulatory update?

More details are provided in the press release titled “Taysha Gene Therapies Announces FDA Breakthrough Therapy Designation and Provides Positive Regulatory Update on TSHA-102 in Rett Syndrome,” which is attached as Exhibit 99.1.

What type of SEC filing did Taysha Gene Therapies use for this disclosure?

Taysha Gene Therapies used a Form 8-K to report the issuance of its press release regarding the FDA Breakthrough Therapy designation and regulatory update for TSHA-102.