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Taysha Gene Therapies Reports Second Quarter 2025 Financial Results and Provides Corporate Update
Commenced site activation for REVEAL pivotal trial in accordance with previously aligned upon key design elements, following receipt of No Objection Letter
About this update from Taysha Gene Therapies, Inc.
[{"type":"text","content":"Commenced site activation for REVEAL pivotal trial in accordance with previously aligned upon key design elements, following receipt of No Objection Letter (NOL) from Health Canada and feedback from the FDA; patient enrollment anticipated to begin in Q4 2025 High dose and low dose TSHA-102 continue to be generally well tolerated with no treatment-related SAEs or DLTs in the 12 patients treated in Part A of REVEAL Phase 1/2 trials as of August 2025 data cutoff Part A data from REVEAL Phase 1/2 trials presented at IRSF Scientific Meeting showed 100% response rate for pivotal trial primary endpoint of gain/regain of ≥ one developmental milestone, corroborated by improvements in key secondary endpoints post-TSHA-102 Company anticipates reporting new supplemental REVEAL Part A clinical data supporting TSHA-102 therapeutic impact in Q4 2025Gross proceeds of $230 million public follow-on offering, including full exercise of the underwriters’ option to purchase additional shares, strengthen balance sheet and extend cash runway into 2028 Conference call and webcast today at 8:30 AM Eastern Time DALLAS, Aug. 12, 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 reported financial results for the second quarter ended June 30, 2025, and provided a corporate update. “We have made strong progress across the Company supporting the advancement of our TSHA-102 development program toward potential registration for females two years and older with Rett syndrome. In May, we announced alignment with the FDA on key design elements of our REVEAL pivotal trial, and subsequently, submitted our IND application and CTA amendments to both the FDA and Health Canada. I’m pleased to share we have commenced site activation in accordance with the key design elements previously aligned on with the FDA, based on feedback recently received from these regulatory agencies. As a result, we anticipate beginning patient enrollment in the fourth quarter of this year,” said Sean P. Nolan, Chairman and Chief Executive Officer of Taysha. “Our frequent and constructive dialogue with the FDA through the Regenerative Medicine Advanced Therapy (RMAT) mech...