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Taysha Gene Therapies, Inc.'s lead asset is TSHA-102. This is an intrathecal AAV9 gene therapy for Rett with a 100% Phase 1/2 responder rate and favorable safety. The FDA granted it a Breakthrough Therapy Designation. Its pivotal REVEAL trial finalized with a 6-month interim that could accelerate a BLA submission. The new trial uses objective, blinded, video-rated milestone gains. This will mak...
DALLAS, Oct. 03, 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 announced that, on October 1, 2025, the Compensation Committee of Taysha's Board of Directors granted se...
Breakthrough Therapy designation granted based on FDA's review of available clinical evidence of safety and efficacy from all 12 patients treated in Part A of the REVEAL Phase 1/2 trials Finalized FDA alignment on REVEAL pivotal trial protocol and SAP following resolution of remaining clinical and statistical queries to IND application amendment; on track to begin patient enrollment in Q4 2025 ...
DALLAS, Sept. 05, 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 announced that, on September 2, 2025, the Compensation Committee of Taysha's Board of Directors granted...
Taysha Gene Therapies, Inc. (NASDAQ:TSHA ) Q2 2025 Earnings Conference Call August 12, 2025 8:30 AM ET Company Participants Hayleigh Collins - Director of Corporate Communications & Investor Relations Kamran Alam - CFO & Corporate Secretary Sean P. Nolan - CEO & Chairman Sukumar Nagendran - President, Head of Research & Development and Director Conference Call Participants Biren N.
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
DALLAS, Aug. 05, 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 announced that it will report its financial results for the second quarter ended June 30, 2025, and host...
DALLAS, Aug. 01, 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 announced that, on August 1, 2025, the Compensation Committee of Taysha's Board of Directors granted one...
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