Trial Profile

A global, potentially registrational Phase 2/3 study of WVE-003 in Patients With Huntington's Disease

Status: Planning

Phase of Trial: Phase II/III

Latest Information Update: 18 May 2025

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At a glance

Drugs WVE-003 (Primary)
Indications Huntington's disease
Focus Registrational; Therapeutic Use

Most Recent Events

08 May 2025 According to Wave Life Sciences media release, company has received supportive initial feedback from FDA, who recognize the severity of HD and are receptive to and engaged with company regarding a potential pathway to accelerated approval. Preparation is ongoing for a potentially registrational, global phase 2/3 study of WVE-003 in adults with SNP3 and HD using caudate atrophy as a primary endpoint.
18 Nov 2024 New trial record
12 Nov 2024 According to Wave Life Sciences ,Wave expects to submit an Investigational New Drug application for WVE-003 in the second half of 2025.

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