Business
Taysha Gene Therapies Reports First Quarter 2024 Financial Results and Provides Corporate Update
Completed dosing in cohort one (low dose, 5.7x1014 total vg) of REVEAL Phase 1/2 adolescent and adult trial with longer-term data supporting the safety
About this update from Taysha Gene Therapies, Inc.
[{"type":"text","content":"Completed dosing in cohort one (low dose, 5.7x1014 total vg) of REVEAL Phase 1/2 adolescent and adult trial with longer-term data supporting the safety profile and durable response of TSHA-102; enrolled first patient in cohort two (high dose, 1x1015 total vg) with dosing scheduled for Q2 2024 Dosed second pediatric patient in cohort one (low dose, 5.7x1014 total vg) of REVEAL Phase 1/2 pediatric trial in Q1 2024 FDA granted Regenerative Medicine Advanced Therapy designation following review of available safety and efficacy data from the first three patients dosed with the low dose of TSHA-102 across both REVEAL trials (adolescent/adult and pediatric) Initial data from cohort one (low dose, 5.7x1014 total vg) in REVEAL pediatric trial and update from cohort one in REVEAL adolescent and adult trial expected mid-2024; initial data from cohort two (high dose, 1x1015 total vg) in both trials (adolescent/adult and pediatric) expected in 2H 2024 Conference call and live webcast today at 4:30 PM Eastern Time DALLAS, May 14, 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 first quarter ended March 31, 2024, and provided a corporate update. “We are pleased with the recent progress we have made to advance our TSHA-102 program in clinical evaluation for Rett syndrome, including enrolling the first patient in the high dose cohort of our REVEAL adolescent and adult trial earlier than planned and dosing the second patient in our REVEAL pediatric trial. We recently received RMAT designation for TSHA-102 following the FDA’s review of safety and efficacy data from the first three patients dosed with the low dose of TSHA-102 across both of our REVEAL trials, which we believe reinforces the therapeutic potential of TSHA-102,” said Sean P. Nolan, Chairman and Chief Executive Officer of Taysha. “We look forward to the year ahead as we remain focused on moving to the high dose cohort and generating critical longer-term clinical data across a broad population of patients with Rett syndrome that will guide the next phase of our studies. We expect to report initial clinical data from our REVEAL p...