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Taysha Gene Therapies Reports Full-Year 2024 Financial Results and Provides Corporate Update
High dose and low dose of TSHA-102 continue to be generally well tolerated with no treatment-related SAEs or DLTs in all pediatric, adolescent and adult
About this update from Taysha Gene Therapies, Inc.
[{"type":"text","content":"High dose and low dose of TSHA-102 continue to be generally well tolerated with no treatment-related SAEs or DLTs in all pediatric, adolescent and adult patients treated (high dose, n=6; low dose, n=4) across both REVEAL trials as of February 2025 data cutoff Completed dosing of the 10 patients in Part A of both REVEAL trials; maturing dataset continues to support advancement toward pivotal Part B trial Productive ongoing discussions with the FDA to solidify regulatory pathway for TSHA-102; update on pivotal trial design expected in H1 2025 Clinical data from cohort two (high dose) and cohort one (low dose) of both REVEAL trials expected in H1 2025 Conference call and live webcast today at 8:30 AM Eastern Time DALLAS, Feb. 26, 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 full year ended December 31, 2024, and provided a corporate update. “We are pleased with the pace at which our TSHA-102 clinical program is advancing across a broad range of ages and stages of patients with Rett syndrome. TSHA-102 continues to be well tolerated in the pediatric, adolescent and adult patients treated across the high dose and low dose cohorts of our two REVEAL trials. With dosing of the 10 patients in Part A of our REVEAL trials complete, we have a strong, maturing dataset in hand to further solidify the regulatory pathway for TSHA-102 with the U.S. Food and Drug Administration (FDA),” said Sean P. Nolan, Chairman and Chief Executive Officer of Taysha. “We remain encouraged by our productive, ongoing discussions with the FDA, and we look forward to providing an update on the pivotal trial design for our TSHA-102 program in the first half of 2025. We also expect to provide an update on the clinical data from Part A, including the low and high dose cohorts in our adolescent and adult trial, as well as our pediatric trial, in the first half of 2025. We remain confident in our differentiated gene therapy candidate, which we believe has potential to provide meaningful therapeutic benefit to a broad population of patients with Rett syndrome.” Recent Corporate and TSHA-102 Program Highlights C...