Taysha Gene Therapies(US:TSHA) Globenewswireยท2025-11-04 12:00Core Insights - Taysha Gene Therapies received FDA Breakthrough Therapy designation for TSHA-102, indicating the drug's potential for treating Rett syndrome, a condition with significant unmet medical needs [3][4] - The company has finalized alignment with the FDA on the REVEAL pivotal trial protocol and statistical analysis plan, which includes a six-month interim analysis that could expedite the Biologics License Application (BLA) submission by at least two quarters [3][4] - Taysha regained full rights to the TSHA-102 program, allowing for strategic flexibility and a focus on long-term value creation [4][6] Company Updates - Taysha is set to dose the first patient in the REVEAL pivotal trial in Q4 2025, with additional patient enrollment expected to continue at multiple sites [4][6] - The company presented new supplemental analysis at the CNS Annual Meeting, showing broad and consistent functional skill improvements in patients treated with TSHA-102 [6] - Taysha's Chief Commercial Officer, David McNinch, was appointed in September 2025, bringing extensive experience in commercialization and strategic market development [6] Financial Performance - For Q3 2025, Taysha reported a net loss of $32.7 million, or $0.09 per share, compared to a net loss of $25.5 million, or $0.10 per share, for the same period in 2024 [13][16] - Research and development expenses increased to $25.7 million in Q3 2025 from $14.9 million in Q3 2024, driven by BLA-enabling initiatives and clinical trial activities [6][13] - As of September 30, 2025, Taysha had $297.3 million in cash and cash equivalents, expected to support operations into 2028 [13][18]