Trial Profile

Phase 3 study of EDG-5506 (Sevasemten)

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 03 Feb 2026

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At a glance

13 Jan 2026 According to a Edgewise Therapeutics media release, company plan to finalize the design and plan for a Phase 3 trial in individuals with Duchenne muscular dystrophy (Duchenne) in the second half of 2026.
26 Jun 2025 According to a Edgewise Therapeutics media release, the Company plans to meet with the FDA in the fourth quarter of 2025 to discuss a Phase 3 design including input on the patient population and endpoints, with plans to initiate the pivotal study in 2026.
02 Apr 2025 According to a Edgewise Therapeutics media release, the company has announced the pricing of its 9,935,419 shares and anticipates gross proceeds from the offering to be approximately $200 million. The company intends to use the net proceeds from this offering to support many research activities along with the advancement of this trial.

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