Taysha Gene Therapies’ TSHA-102 Receives the US FDA’s Fast Track Designation for Rett Syndrome
Shots:
- TSHA-102, a self-complementary intrathecally delivered AAV9 gene transfer therapy received FTD from the US FDA for Rett syndrome. TSHA-102 is being studied in the P-I/II study (REVEAL) in Canada where initial data from 1st adult patient dosing with TSHA-102 is encouraging while 2nd patient dosing is expected in Q3’23
- The US FDA has cleared an IND application of TSHA-102 for pediatric patients with an expected first pediatric patient dosing in Q4’24. The company continues to discuss with the US FDA to bring TSHA-102 to patients shortly
- The therapy is designed to mediate levels of MECP2 in the CNS on a cell-by-cell basis without risk of overexpression using miRARE technology. TSHA-102 received ODD & Rare Pediatric Disease designations from the US FDA & ODD from the EMA
Ref: Taysha Gene Therapies | Image: Taysha Gene Therapies
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
