Taysha Program Update: January 2026

Taysha Gene Therapies has shared an update on its TSHA-102 gene therapy program for Rett syndrome through a press release and a community letter. Links to both documents are available below.

Highlights include:

• The first participant was dosed in the REVEAL Pivotal Study in the fourth quarter of 2025. Enrollment is ongoing across multiple clinical trial sites.

• Taysha reached written alignment with the U.S. Food and Drug Administration (FDA) on a study for younger girls (ASPIRE Study).

• All participants in both the REVEAL Pivotal Study and the ASPIRE Study are expected to be dosed by the second quarter of 2026.

• Longer-term safety and efficacy data from Part A of the REVEAL Phase 1/2 study is expected in the first half of 2026.

 

Study overview:

• REVEAL Pivotal Study: Evaluating the safety and efficacy of TSHA-102 in 15 girls and young women ages 6 to under 22 with typical Rett syndrome. The primary endpoint measures whether participants gain or regain at least one of 28 defined developmental milestones.
• ASPIRE Study: Evaluating safety and preliminary efficacy of TSHA-102 in three girls ages 2 to under 4. Data from this study is expected to support future regulatory submissions for patients ages 2 and older

Questions can be directed to patientaffairs@tayshagtx.com

RSRT will continue to share updates as this program progresses.

More information is available by reading Taysha’s community letter and press release below.