Neurizon Therapeutics (ASX:NUZ) said that the Sean M. Healey & AMG Center for ALS at Mass General Brigham in Massachusetts received clearance from the US Food and Drug Administration to proceed with the NUZ-001 regimen, Neurizon's drug candidate for the treatment of amyotrophic lateral sclerosis (ALS), in the Healey ALS Platform trial after the regulator completed a 30-day review, according to a Thursday Australian bourse filing.

The US FDA's acceptance of the protocol amendment allows the firm and the clinical trial team to progress to the next operational phases, including submissions to the Institutional Review Board, activation of clinical trial sites, and initiation of study start-up activities.

The trial tests and evaluates multiple investigational drugs simultaneously, sharing infrastructure across trial sites.

The first patients are expected to be enrolled early in 2026, the filing said.