Taysha Gene Therapies TSHA-102 Program Progress Announced
Taysha Gene Therapies announced progress across the TSHA-102 pivotal program, an intrathecally delivered AAV9 gene therapy with disease modifying potential, in clinical evaluation for the treatment of Rett syndrome. TSHA-102 Program Updates and Overview: Dosed First Patient in REVEAL Pivotal Trial in the Fourth Quarter of 2025; Reached Written FDA Alignment on ASPIRE Trial and Data for Inclusion in BLA Submission to Enable Broad Label Following Type D Meeting. Anticipated Milestones: Completion of dosing in the REVEAL pivotal trial is expected in the second quarter of 2026; Completion of dosing in the ASPIRE trial is expected in the second quarter of 2026; Update on longer-term safety and efficacy data from Part A of the REVEAL Phase 1/2 trials is expected in the first half of 2026
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Taysha Gene Therapies Doses First Patient in TSHA-102 Pivotal Trial for Rett Syndrome
- Trial Progress: Taysha Gene Therapies successfully dosed the first patient in the TSHA-102 pivotal trial in Q4 2025, with plans to complete dosing for all 15 patients by Q2 2026, marking a significant milestone in the treatment of Rett syndrome.
- FDA Alignment: The company reached written alignment with the FDA to include three months of safety data from the ASPIRE trial in its planned BLA submission, aiming to enable broad labeling for patients aged two and older, which will expedite the path to market.
- Market Opportunity: With an estimated 15,000 to 20,000 patients affected by Rett syndrome across the U.S., EU, and U.K., Taysha aims to redefine the treatment paradigm for this high unmet need disease through compelling clinical data from TSHA-102, presenting a significant market opportunity.
- Long-term Data Update: An update on long-term safety and efficacy data from the REVEAL trial is expected in H1 2026, which will provide crucial support for the company's future treatment strategies and enhance its competitive position in the market.

Taysha Grants 212,000 Stock Options to New Employees
- Employee Incentive Program: On December 3, 2025, Taysha Gene Therapies granted 212,000 stock options to two new employees at an exercise price of $4.49 per share, aimed at attracting and retaining key talent, thereby enhancing the company's competitive edge in the gene therapy sector.
- Option Structure: These options will be valid for 10 years and vest over four years, with 25% vesting on the first anniversary and the remaining 75% vesting in equal monthly installments over the subsequent 36 months, ensuring continued employee contributions during their tenure.
- Compliance Assurance: The stock option grant complies with Nasdaq Listing Rule 5635(c)(4), demonstrating the company's commitment to transparency and compliance in talent acquisition, which can bolster investor confidence.
- Strategic Goals: Taysha focuses on developing gene therapies for severe monogenic diseases, particularly its clinical program TSHA-102 for Rett syndrome, and aims to accelerate research and development through these incentive measures to address unmet medical needs.









