Taysha Gene Therapies Inc

Taysha Gene Therapies announced it expects to report top-line data from the 6-month interim analysis of its REVEAL pivotal trial and receive FDA feedback on the BLA submission pathway in the first half of 2027, while remaining on track to complete the BLA-enabling PPQ campaign in the fourth quarter of 2026. CEO Sean Nolan said the REVEAL trial was over-enrolled with 17 patients dosed with TSHA-102, and the age mix may support a broad label. The company disclosed a single moderate Grade 2 treatment-related adverse event of peripheral sensory neuropathy classified as an SAE due to overnight admission, with the patient showing substantial recovery. CFO Kamran Alam reported a quarter-end cash balance of $455.4 million, which includes $230 million in gross proceeds from a June 2026 follow-on financing, and said the cash runway extends into the second half of 2028. Net loss for the quarter was $46.6 million, or $0.13 per share.

Taysha Gene Therapies and Catalent have signed a commercial supply agreement for TSHA-102, Taysha’s investigational gene therapy for Rett syndrome, under which Catalent will serve as the primary commercial manufacturer following potential FDA approval. The agreement builds on a partnership that has supported TSHA-102 development since 2020 and secures long-term manufacturing capacity at Catalent’s FDA-licensed gene therapy facility in Harmans, Maryland. Catalent will provide GMP manufacturing and commercial supply, leveraging its experience across more than 90 gene therapy programs. Taysha’s Chairman and CEO Sean P. Nolan stated that establishing long-term commercial manufacturing capacity is a critical component of the company’s launch readiness strategy, with BLA-enabling Process Performance Qualification activities already underway. Rett syndrome, caused by mutations in the MECP2 gene, affects an estimated 15,000 to 20,000 patients in the U.S., EU, and U.K., and currently has no approved disease-modifying therapies.