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| Reaffirmed FDA alignment on TSHA-102 BLA pathway, including pivotal trial design, endpoints and potential to submit for approval based on REVEAL pivotal trial 6-month interim analysis, following recent breakthrough therapy Type B meeting |
| Further advanced dosing in the REVEAL pivotal trial, with enrollment in the ASPIRE trial ongoing across multiple sites; on track to complete dosing in REVEAL and ASPIRE in Q2 2026 |
| Maintained favorable tolerability profile with no treatment-related SAEs or DLTs in REVEAL Phase 1/2 and REVEAL pivotal trials as of May 2026 data cutoff; plan to present longer-term safety and efficacy data from Part A of REVEAL Phase 1/2 trials in Q2 2026 |
| Initiated BLA-enabling PPQ campaign for TSHA-102 in April 2026; completion expected in Q4 2026 |
| Conference call and webcast today at 8:30 AM ET |
DALLAS, May 06, 2026 (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, 2026, and provided a corporate update.
“We continued to execute our clinical development strategy for TSHA-102 and recently reaffirmed alignment with the FDA on our pathway to a BLA filing, including trial design, endpoints and the potential to submit for approval based on the six-month interim analysis from the REVEAL pivotal trial,” said Sean P. Nolan, Chairman and Chief Executive Officer of Taysha. “We further advanced dosing in the REVEAL pivotal trial, with enrollment in the ASPIRE trial ongoing across multiple sites, and we remain on track to complete dosing in both trials this quarter. In parallel, we plan to report longer-term safety and efficacy data from Part A of our REVEAL Phase 1/2 trials in the second quarter of this year.”
Mr. Nolan continued, “Our pivotal development strategy is grounded in the rigor of our natural history analysis and Part A data collection and evaluation, with trial design, endpoints and statistical analyses developed based on discussions with the FDA. In our upcoming Part A data readout, we expect to report longer-term follow-up, including at least 12-month data from all 12 pediatric, adolescent and adult patients treated with TSHA-102. These results will include functional gains based on natural history-defined developmental milestones and additional skills and improvements that impact activities of daily living. We look forward to sharing this data as we continue to demonstrate the differentiated opportunity for TSHA-102 to deliver meaningful benefit to a broad population of patients with Rett syndrome who continue to face high unmet medical need.”
Recent Corporate and TSHA-102 Program Highlights
