Catalyst overview
Research summary
This catalyst tracks a Phase 1/2 data readout for TN-201 in Hypertrophic cardiomyopathies . The expected timing is based on the latest available company guidance and may change.
MyPeak-1 trial. 10/23- Initiated dosing. 5/14/24- RPDD granted. 7/30/25- DSMB positive safety review. 11/4/25- FDA placed study on hold. 11/8/25- Interim safety & early efficacy data presented at AHA'25. 12/11/25:- FDA lifted MyPEAK-1 hold. Protocol changes underway; dosing to resume; timelines unchanged. 03/11/26:- Enrollment resumed in MyPEAK-1. Interim Cohort 2 and Cohort 1 updates H1 2026; longer-term data H2 2026. 05/06/26:- ESC HF 2026 to present immunosuppression and safety for first seven MyPEAK-1 patients; broader Cohort data Q2 2026. 06/02/26:- New MyPEAK-1 Cohort 1 and 2 interim data webcast June 3, 2026. 08/05/26:- MyPEAK-1 interim data positive; additional data and regulatory update expected Q4 2026.
Verification
Confirm timing and program details against the company announcement or filing.