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Taysha Gene Therapies Regains Full Rights to Lead TSHA-102 Program in Clinical Evaluation for the Treatment of Rett Syndrome
The 2022 Option Agreement between Astellas and Taysha has expired Regaining full rights to TSHA-102 Rett syndrome program enables Taysha to focus on driving
About this update from Taysha Gene Therapies, Inc.
The 2022 Option Agreement between Astellas and Taysha has expired Regaining full rights to TSHA-102 Rett syndrome program enables Taysha to focus on driving its long-term value with full strategic flexibility and optionality TSHA-102 has demonstrated compelling Part A REVEAL Phase 1/2 safety and efficacy data, received FDA Breakthrough Therapy designation and is advancing with a clear path to potential registration Dosing of the first patient in the REVEAL pivotal trial is scheduled this quarter DALLAS , Oct. 16, 2025 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA) (Taysha or the Company), a clinical-stage biotechnology company focused on advancing adeno-associated virus (AAV)-based gene therapies for severe monogenic diseases of the central nervous system (CNS), today announced that the Company has regained full rights to its lead TSHA-102 program in clinical evaluation for Rett syndrome. The 2022 Option Agreement between Astellas and Taysha, which had granted Astellas the exclusive option to enter a negotiation period to obtain an exclusive license to TSHA-102 in Rett syndrome and certain rights with respect to change in control transactions involving Taysha, has expired. In accordance with the 2022 Option Agreement, Taysha delivered a TSHA-102 data package to Astellas in mid-2025 that contained the previously disclosed Part A REVEAL clinical data ( May 2025 data cutoff), initiating a 90-day review period for Astellas to elect to exercise an option to trigger exclusive negotiations for a transaction. These data were shared with the U.S. Food and Drug Administration (FDA) as part of the application for, and subsequent receipt of, Breakthrough Therapy designation for TSHA-102. Following the expiration of the Option Agreement, Taysha now holds unencumbered rights to the TSHA-102 program. These previously disclosed Part A REVEAL clinical data ( May 2025 data cutoff) demonstrated a generally well-tolerated safety profile and a 100% response rate post-TSHA-102 for the pivotal trial primary endpoint of the gain/regain of ≥ one defined developmental milestone, with
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