Neurizon Therapeutics (ASX:NUZ) has opened Monday up +7% after the U.S. Food and Drug Administration lifted the clinical hold on its lead investigational drug, NUZ-001, which will now enable the Australian biotech company to proceed with clinical development for amyotrophic lateral sclerosis.
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The clearance represents a major regulatory milestone for Neurizon, paving the way for Phase 2/3 participation in the HEALEY ALS Platform Trial, expected to commence in the fourth quarter of calendar year 2025.
Managing director and CEO Dr Michael Thurn described the decision as a “huge step” in Neurizon’s mission to develop treatments for neurodegenerative diseases.
“The FDA’s clearance of our IND application marks a significant milestone in our mission to bring NUZ-001 closer to patients living with ALS,” Thurn said, acknowledging the contributions of clinical partners, key opinion leaders, and patient advocacy groups in advancing the program.
The company highlighted the Investigational New Drug application was underpinned by robust preclinical safety data and comprehensive manufacturing and quality documentation. These datasets stem from Neurizon’s licensing agreement with Elanco, which provides detailed safety and manufacturing support to strengthen regulatory confidence in the program.
Neurizon said the IND establishes a validated framework for safety, manufacturing, and clinical design, which is expected to reduce regulatory risk, shorten development timelines, and streamline future programs built around the NUZ-001 platform molecule. The company views this regulatory progress as a foundation for pipeline expansion and potential future partnerships, as well as a key step toward accelerated pathways for ALS and related neurodegenerative indications.
With the IND active, Mass General Hospital will soon file a protocol amendment for the HEALEY ALS Platform Trial in the coming weeks.
Patient enrolment is projected to begin in Q4 FY25.
NUZ are selling at 15.5c each on Monday.
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