Taysha Gene Therapies reports Q3 EPS (9c), consensus (9c)

Reports Q3 revenue $0, consensus $1.38M. “The progress we’ve made in the third quarter of 2025 sets the stage for a potentially transformative period ahead for Taysha. We recently received FDA Breakthrough Therapy designation, which reflects the FDA’s recognition of the therapeutic potential of TSHA-102 for individuals with Rett syndrome, who face a profound unmet need. Additionally, we’re pleased to have finalized alignment with the FDA on our pivotal trial protocol and SAP, including a six-month interim analysis, which we believe provides a clear opportunity to expedite our BLA submission by at least two quarters,” said Sean P. Nolan, Chairman and Chief Executive Officer of Taysha. “With Breakthrough Therapy designation and finalized FDA alignment, together with our strong balance sheet and regained global rights to TSHA-102, we believe we are strongly positioned to initiate our REVEAL pivotal trial and accelerate execution toward BLA submission. We remain on track to dose the first patient in the REVEAL pivotal trial this quarter and expect additional enrollment to continue at multiple sites this quarter. With an estimated 15,000 to 20,000 patients affected by Rett syndrome across the U.S., EU and U.K. and compelling clinical data from Part A of our REVEAL trials, we see a significant opportunity to bring an innovative therapy with disease-modifying potential to patients.”