Catalyst overview
Research summary
This catalyst tracks a Phase 1b data readout for SGT-212 (dual route) in Friedreich’s Ataxia. The expected timing is based on the latest available company guidance and may change.
1/21/25- FDA Fast Track Designation. Planned Ph1b trial. 8/12/25- Initiate trial in Q4 2025. 11/03/25:- First FALCON Ph1b site activated and screening started; trial initiation remains expected in Q4 2025. 01/12/26:- First FALCON Ph1b participant dosed; preliminary safety coming months; initial data update in H2 2026. 01/13/26:- Received FDA Orphan and Rare Pediatric Disease designations; FALCON Ph1b initial data still expected H2 2026. 03/06/26:- FALCON Ph1b SGT-212 efficacy and safety poster at MDA on March 10, 2026. 03/19/26:- FALCON Ph1b dosing ongoing; SGT-212 remains well tolerated without treatment-related AEs; initial data expected H2 2026. 05/12/26:- Two FALCON Ph1b participants dosed; well tolerated; initial data expected by year-end 2026. 08/06/26:- FALCON Ph1b dosing tolerated. Initial data expected in Q1 2027.
Verification
Confirm timing and program details against the company announcement or filing.