Taysha Gene Therapies Stock Rises on Promising Rett Syndrome Trial Results
Shares of Taysha Gene Therapies (NASDAQ:TSHA) experienced a significant uptick in early trading on Monday, marking a 3.6% increase. This surge follows the company’s announcement of the completion of patient enrollment in a pivotal clinical trial for a Rett syndrome treatment and the subsequent release of long-term clinical data.
REVEAL Trial Shows Positive Outcomes for TSHA-102
The life sciences company confirmed that it has successfully enrolled 17 patients in the REVEAL pivotal trial, which is evaluating the efficacy of TSHA-102 in treating Rett syndrome. Key data from the interim analysis, along with feedback from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) submission pathway, are anticipated in the first half of 2027.
Based on data compiled as of the June 2026 data cutoff for both the REVEAL Phase 1/2 and pivotal trials (encompassing a total of 29 patients), TSHA-102 has demonstrated a generally favorable tolerability profile. No serious treatment-related adverse events or dose-limiting toxicities have been reported.
Significant Functional Improvements Observed
In Part A of the REVEAL trial, 100% of patients aged 6 to 21 years achieved or regained at least one developmental milestone by the 12-month treatment mark. These responses were consistent across varying ages and disease severity.
Twelve patients have shown a cumulative total of 310 functional improvements over 12 months post-treatment, averaging approximately 26 improvements per patient. This includes 31 new developmental milestones and 279 additional technical advancements or improvements.
Long-term observational results indicate that the treatment effects are sustained and intensifying over time, with functional improvements accumulating across all key disease areas as time progresses following treatment.
The incidence of developmental milestone improvements post-TSHA-102 administration increased by 69% between the six-month and twelve-month marks, and by 94% between six months and over twelve months.
ASPIRE Trial Enrollment Also Completed
Taysha has also completed enrollment in the ASPIRE trial, a Phase 1 study that has enrolled four patients aged 2 to 5 years.
The company anticipates completing enrollment for the ASPIRE trial in July 2026 and expects to complete the efficacy assessment campaign for the BLA for TSHA-102 in the fourth quarter of 2026.
