Taysha Gene Therapies reports Q2 EPS (9c), consensus (8c)

Reports Q2 revenue $1.986M, consensus $1.6M. “We have made strong progress across the Company supporting the advancement of our TSHA-102 development program toward potential registration for females two years and older with Rett syndrome. In May, we announced alignment with the FDA on key design elements of our REVEAL pivotal trial, and subsequently, submitted our IND application and CTA amendments to both the FDA and Health Canada. I’m pleased to share we have commenced site activation in accordance with the key design elements previously aligned on with the FDA, based on feedback recently received from these regulatory agencies. As a result, we anticipate beginning patient enrollment in the fourth quarter of this year,” said Sean P. Nolan, Chairman and Chief Executive Officer of Taysha. “Our frequent and constructive dialogue with the FDA through the Regenerative Medicine Advanced Therapy (RMAT) mechanism has been instrumental in enabling us to navigate this novel regulatory pathway. With a strengthened balance sheet, our pivotal trial underway and a clear path to registration, we believe we are well positioned to advance TSHA-102 to benefit patients living with this devastating disease.”