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Taysha Gene Therapies Reports First Quarter 2025 Financial Results and Provides Corporate Update
Obtained written alignment from the FDA on key elements of TSHA-102 pivotal Part B trial design and next steps on enabling study initiation The FDA advised
About this update from Taysha Gene Therapies, Inc.
[{"type":"text","content":"Obtained written alignment from the FDA on key elements of TSHA-102 pivotal Part B trial design and next steps on enabling study initiation The FDA advised the Company to submit pivotal Part B trial protocol and associated statistical analysis plan as an amendment to the IND application, eliminating the need for formal end-of-phase meeting and potentially expediting study initiation and registration; IND amendment submission expected in Q2 2025 High dose and low dose of TSHA-102 continue to be generally well tolerated with no treatment-related SAEs or DLTs in the pediatric, adolescent and adult patients treated (high dose, n=6; low dose, n=4) across both REVEAL trials as of April 10, 2025, data cutoff Program update on pivotal trial design, Rett syndrome natural history data analysis and clinical data from cohort two (high dose) and cohort one (low dose) of both REVEAL trials expected in Q2 2025 in conjunction with IRSF Rett Syndrome Scientific Meeting Conference call and live webcast today at 8:30 AM Eastern Time DALLAS, May 15, 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 first quarter ended March 31, 2025, and provided a corporate update. “We are pleased with the significant regulatory and clinical progress across our TSHA-102 program in clinical evaluation for children, adolescents and adults suffering from Rett syndrome. We believe our interactions with the U.S. FDA under the RMAT mechanism have consistently been productive and continue to support a clear path to registration,” said Sean P. Nolan, Chairman and Chief Executive Officer of Taysha. “Importantly, we reached alignment with the FDA on key elements of the pivotal Part B trial design for TSHA-102 and next steps on enabling study initiation. Subsequently, the FDA advised us to proceed directly to submitting our pivotal trial protocol and associated statistical analysis plan as an amendment to the IND application, which we expect to submit in the current quarter. By eliminating the need for a formal end-of-phase meeting, this approach may expedite study initiation and registration.” Mr. Nolan continued,...