Taysha Gene Therapies Finishes Dosing in REVEAL Trial

By Philip Seaworth • Monday, June 22 10:53 • Permanent Link

Taysha Gene Therapies said it has finished dosing all 17 patients in its REVEAL pivotal trial of TSHA-102 for Rett syndrome, up from 12 patients in the Part A phase 1/2 study reported earlier. The company also said it is now tracking toward a first-half 2027 readout on topline pivotal-trial data and FDA feedback on the biologics license application pathway.

In the longer-term Part A data, 12 females ages 6 to 21 years had at least 12 months of follow-up. Every one of the 12 patients gained or regained at least one developmental milestone by 12 months after treatment. Taysha said those patients generated 310 total functional gains by that point, equal to about 26 gains per patient. That total included 31 developmental milestones and 279 additional skill gains or improvements.

The company said the 310-gain total was up from the 6-month mark, with milestone gains rising 69% from 6 to 12 months and 94% from 6 months to at least 12 months. It also said some patients with the longest follow-up, at 30 months, were still showing functional gains.

Safety data were unchanged in the latest update: across the REVEAL phase 1/2 and pivotal trials, covering 29 patients, Taysha reported no treatment-related serious adverse events or dose-limiting toxicities as of the June 2026 cutoff.

The pivotal trial’s 17 patients were all females in the 6 to under 22 age range. The company said the trial’s response-rate threshold is 33%, and that the interim analysis supporting the planned filing will come after all 17 patients complete six months of follow-up.

Taysha also updated its ASPIRE trial, saying enrollment is above the original target of three patients. It now plans to dose four females ages 2 to under 4, including one additional screened and eligible patient beyond the initial plan. The company expects dosing in ASPIRE to finish in July 2026.

Looking ahead, Taysha said completion of the TSHA-102 process performance qualification campaign is expected in the fourth quarter of 2026, with topline pivotal-trial data and FDA feedback on the filing path due in the first half of 2027. Today the company's shares have moved 1.79% to a price of $6.535. Check out the company's full 8-K submission here.

The above analysis is intended for educational purposes only and was performed on the basis of publicly available data. It is not to be construed as a recommendation to buy or sell any security. Any buy, sell, or other recommendations mentioned in the article are direct quotations of consensus recommendations from the analysts covering the stock, and do not represent the opinions of Market Inference or its writers. Past performance, accounting data, and inferences about market position and corporate valuation are not reliable indicators of future price movements. Market Inference does not provide financial advice. Investors should conduct their own review and analysis of any company of interest before making an investment decision.