Taysha Gene Therapies reported full-year 2025 financial results with research and development expenses of $86.4 million, general and administrative expenses of $33.9 million, and net loss of $109.0 million ($0.34 per share), alongside $319.8 million in cash and cash equivalents as of December 31, 2025. The company provided updates on TSHA-102 program progress, including dosing in REVEAL pivotal and ASPIRE trials on track for Q2 2026 completion and FDA alignments on BLA requirements.
Key takeaways
Dosed multiple patients in REVEAL pivotal trial of TSHA-102 for Rett syndrome; on track to complete dosing in Q2 2026
Received FDA clearance to initiate ASPIRE trial in three patients aged 2 to <4 years; on track to complete dosing in Q2 2026
TSHA-102 showed no treatment-related SAEs or DLTs in REVEAL Phase 1/2 and pivotal trials as of March 2026 data cutoff
Reached FDA written alignment on PPQ and comparability strategy for TSHA-102 commercial manufacturing to support BLA submission
Net loss of $109.0 million ($0.34 per share) for year ended December 31, 2025, compared to $89.3 million ($0.36 per share) in 2024
Cash and cash equivalents of $319.8 million as of December 31, 2025, sufficient to fund operations into 2028