Taysha Reports Q4 2025 Earnings, Highlights FDA Alignment and Breakthrough Therapy Designation for TSHA-102

Taysha (TSHA) reported Q4 2025 earnings, highlighting a 100% response rate in 10 patients treated with TSHA-102 in the REVEAL Phase 1/2 trial. The FDA granted breakthrough therapy designation and written alignment on both REVEAL and ASPIRE trial designs. The first patient was dosed in the pivotal REVEAL trial, and enrollment is advancing. TSHA-102 has not caused any serious safety events. The company plans to initiate process performance qualification lots in 2026 and expects to complete them by year-end. R&D expenses increased to $86.4 million in 2025, primarily driven by higher headcount and REVEAL study activities. Net loss was $109 million, or $0.34 per share, for 2025.