Catalyst overview
Research summary
This catalyst tracks a Phase 1/2 data readout for DT-216P2 in Friedreich’s Ataxia. The expected timing is based on the latest available company guidance and may change.
RESTORE-FA trial. 8/14/23- Reported initial data from ongoing Ph 1 MAD trial demonstrating proof-of-concept. 6/4/25- Started patient dosing in Ph1/2 Ex-US trial. 11/05/25:- H2 2026 RESTORE-FA Ph1/2 MAD data, including 12-week FXN expression, anticipated. 03/09/26:- Ongoing RESTORE-FA Ph1/2 MAD dosing; 12-week frataxin data update expected H2 2026. 04/28/26:- RESTORE-FA Ph1/2 MAD ongoing; frataxin biomarker update planned H2 2026. 05/18/26:- Positive 4-week RESTORE-FA Ph1/2 biomarker and clinical data reported. Registrational path plan update expected Q4 2026. 08/03/26:- RESTORE-FA modified; registrational plan update Q4 2026 and 12-week data Q1 2027.
Verification
Confirm timing and program details against the company announcement or filing.