Catalyst overview
Research summary
This catalyst tracks a Phase 3 data readout for Pegtibatinase (TVT-058) in Homocystinuria. The expected timing is based on the latest available company guidance and may change.
COMPOSE, HARMONY trial. Data at SIMD on 4/17/24. Topline data in 2026. Initiates ENSEMBLE in Q2 '24, Ph3b open-label long-term extension study. 1/13/25- Enrollment paused and to restart trial in 2026. 10/30/25:- Manufactured commercial-scale batches; engaging FDA to restart HARMONY Phase 3 enrollment in 2026. 02/19/26:- Resumed enrollment in Phase 3 HARMONY Study for pegtibatinase in classical HCU; topline data still expected in 2026. 05/04/26:- Restarted Phase 3 HARMONY; first new patient dosed; topline data expected H2 2027. 08/04/26:- HARMONY enrollment continues. Topline data expected in H2 2027.
Verification
Confirm timing and program details against the company announcement or filing.