Taysha Gene Therapies reports Q1 EPS (8c) vs (10c) last year

Reports Q1 revenue $2.302M, consensus $1.35M. “We are pleased with the significant regulatory and clinical progress across our TSHA-102 program in clinical evaluation for children, adolescents and adults suffering from Rett syndrome. We believe our interactions with the U.S. FDA under the RMAT mechanism have consistently been productive and continue to support a clear path to registration,” said Sean P. Nolan, Chairman and Chief Executive Officer of Taysha. “Importantly, we reached alignment with the FDA on key elements of the pivotal Part B trial design for TSHA-102 and next steps on enabling study initiation. Subsequently, the FDA advised us to proceed directly to submitting our pivotal trial protocol and associated statistical analysis plan as an amendment to the IND application, which we expect to submit in the current quarter. By eliminating the need for a formal end-of-phase meeting, this approach may expedite study initiation and registration.”