Catalyst overview
Research summary
This catalyst tracks a Phase 3 data readout for LX2006 in Friedreich’s Ataxia. The expected timing is based on the latest available company guidance and may change.
SUNRISE-FA trial. 4/7/25- Reported interim data. 10/7/24- Interim data reported. Pooling data from Ph1/2 studies to support BLA Accelerated Approval. Pivotal trial initiation H1 2026. 11/05/25:- FDA okayed LX2006 comparability; October Ph1/2 interim data positive; registrational trial initiation remains planned H1 2026. 03/30/26:- SUNRISE-FA 2 design/SAP submitted; CDRP meeting held; pivotal trial initiation and FDA feedback expected H1/Q2 2026. 04/27/26:- ASGCT May 13, 2026 LX2006 safety and preliminary efficacy and neurologic data presentations. 05/11/26:- Q2 2026 FDA protocol feedback and SUNRISE-FA 2 pivotal initiation expected; Ph1/2 data show sustained neurologic benefit. 06/15/26:- SUNRISE-FA 2 protocol finalized; initiation Q2 2026, first patient by June 30. Topline H2 2027; BLA H1 2028. 08/12/26:- SUNRISE-FA 2 initiated with first patient enrolled. Topline data is expected in H2 2027; potential BLA submission is expected in H1 2028.
Verification
Confirm timing and program details against the company announcement or filing.