Trial Profile

Phase 3 study of EDG-5506

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 13 Jul 2025

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At a glance

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.
08 Aug 2024 According to a Edgewise Therapeutics media release, this trial is planned to be initiated in the first half of 2025.

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