Taysha Gene Therapies provided an update on the TSHA-120 program in giant axonal neuropathy GAN and a corporate outlook for 2023. "We expect to deliver on several key milestones in 2023, including the generation of first-in-human adult clinical data in Rett syndrome, CTA submission to MHRA to enable initiation of our pediatric Rett syndrome program and submission of an IND for Rett syndrome in the U.S. to further expand our clinical study footprint. For our GAN program, we received the formal FDA meeting minutes and recently submitted follow up questions to clarify some of their recommendations including the feasibility of a proposed study design and the totality of evidence required for BLA submission. Their feedback will help inform next steps for the program in this ultra-rare indication with no approved treatments," said Sean P. Nolan, Chairman and Chief Executive Officer of Taysha. "I believe that the operational, structural and personnel actions recently implemented position us well to execute across our near-term milestones and deliver on our commitments to key stakeholders, especially patients."
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