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Taysha Gene Therapies Reports Third Quarter 2024 Financial Results and Provides Corporate Update
High dose TSHA-102 was generally well tolerated with no SAEs or DLTs in two adolescent/adult patients and one pediatric patient as of data cutoff; IDMC
About this update from Taysha Gene Therapies, Inc.
[{"type":"text","content":"High dose TSHA-102 was generally well tolerated with no SAEs or DLTs in two adolescent/adult patients and one pediatric patient as of data cutoff; IDMC approved continued enrollment in cohort two (high dose) across both REVEAL trials; eight patients dosed to date (low dose=4, high dose=4) Advanced discussions with the FDA on trial design, endpoints and potential use of established natural history dataset for Part B of REVEAL trials, and aligned on a meeting cadence to expedite the development plan for TSHA-102 following initial RMAT Type B meeting FDA approved use of pivotal TSHA-102 product in REVEAL trials based on successful demonstration of analytical comparability; Company released pivotal product manufactured with the final commercial manufacturing process following Type D CMC meeting 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 4:30 PM Eastern Time DALLAS, Nov. 13, 2024 (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 third quarter ended September 30, 2024, and provided a corporate update. “We are pleased with the progress made with the FDA on further elucidating the potential regulatory pathway for TSHA-102 as we advanced discussions on the trial design, endpoints and potential use of an established natural history dataset for Part B of our REVEAL trials. Additionally, we aligned on a meeting cadence to expedite the development plan for TSHA-102,” said Sean P. Nolan, Chairman and Chief Executive Officer of Taysha. “We are in a strong position with CMC, having obtained FDA approval to use the pivotal product in our REVEAL trials based on the successful demonstration of analytical comparability. Subsequently, we released the pivotal product manufactured with the final commercial manufacturing process that we intend to use in Part B.” Mr. Nolan continued, “Clinical data presented from the adult patients with the most advanced stage of the disease treated with the low dose of TSHA-102 indicate a pattern of early clinical improvements and functional gains across multip...