other material
confidence high
sentiment neutral
materiality 0.65
Taysha receives FDA feedback on TSHA-120 GAN; sets Rett syndrome milestones for 2023
Taysha Gene Therapies, Inc.
- FDA acknowledged MFM32 as acceptable endpoint; recommended double-blind placebo-controlled design for TSHA-120 BLA.
- Dosing of first adult Rett patient with TSHA-102 expected H1 2023; initial clinical data also in H1 2023.
- CTA submission to UK MHRA for pediatric Rett syndrome expected mid-2023; IND to FDA planned H2 2023.
- Operational, structural and personnel changes implemented following business review to enhance execution.