Phase 2Data readout

Sevasemten (EDG-5506)

Becker Muscular Dystrophy

EWTXEdgewise Therapeutics

Expected catalystDecember 31, 2026Company guidance: Dec 31, 2026

Catalyst overview

Event details

Drug or asset: Sevasemten (EDG-5506)
Development stage: Phase 2
Event type: Data readout
Indication: Becker Muscular Dystrophy

Research signalsHigh management interest

Research summary

What is being tracked?

This catalyst tracks a Phase 2 data readout for Sevasemten (EDG-5506) in Becker Muscular Dystrophy. The expected timing is based on the latest available company guidance and may change.

Development notes

CANYON/GRAND CANYON trials. 9/26/23- CANYON fully enrolled. Initiated GRAND CANYON. 12/16/24- Met primary endpoint. 3/3/25- Present data at 2025 MDA Conf. on March 16-19, 2025. Engage w/ US FDA in H1 2025 for marketing authorization. 5/8/25- Data from GRAND CANYON expected in Q4 2026 11/06/25:- GRAND CANYON enrollment completed February 2025 (175 adults). Topline 18‑month Becker data still expected Q4 2026. 02/26/26:- GRAND CANYON topline Becker data still expected Q4 2026; potential NDA submission planned H1 2027. 03/03/26:- CANYON poster on LVEF and NT-proBNP presented March 9, 2026 at MDA. 05/07/26:- New CANYON analysis showed well-tolerated cardiac profile; GRAND CANYON topline Becker data still expected Q4 2026. 08/06/26:- Sevasemten muscular dystrophy business sale to Servier completed in July 2026.

Verification

Primary source

Confirm timing and program details against the company announcement or filing.

Open source

What is being tracked?

This catalyst tracks a Phase 2 data readout for Sevasemten (EDG-5506) in Becker Muscular Dystrophy. The expected timing is based on the latest available company guidance and may change.