Taysha: FDA seeks more dosing for CNS candidate

 Type B end-of-Phase 2 meeting with U.S. Food and Drug Administration (FDA) provided additional clarity for TSHA-120 for the treatment of giant axonal neuropathy (GAN) ultra-rare disease program 

- FDA acknowledged MFM32 as an acceptable endpoint with a recommendation to dose additional patients in a double-blind, placebo-controlled design to support Biologics License Application (BLA) submission

Organizational and business review by new management with operational, structural and personnel changes implemented to enhance execution

Dosing of first adult patient with Rett syndrome from ongoing trial in Canada expected in H1 2023; update of initial available clinical data anticipated in H1 2023 with quarterly updates primarily on safety thereafter

https://finance.yahoo.com/news/taysha-gene-therapies-provides-tsha-210100596.html