FDA Clears NUZ-001 For Studies

The FDA cleared the Investigational New Drug application for NUZ-001, paving the way for Phase 2 and 3 studies in amyotrophic lateral sclerosis (ALS). Neurizon will run the HEALEY ALS platform trial with Massachusetts General Hospital, aiming to start in late 2025 and enroll patients within weeks, a move that could slow ALS progression and speed up getting real answers for families.