Neurizon Therapeutics Limited (ASX: NUZ & NUZOA; OTCQB: NUZTF), an Australia-based clinical-stage biotech company, announced on Thursday that that the Sean M. Healey & AMG Centre for ALS at Mass General Brigham has received clearance from the US Food and Drug Administration (FDA) to proceed with Neurizon's NUZ-001 regimen in the HEALEY ALS Platform Trial (ClinicalTrials.gov identifier: NCT04297683) following completion of the FDA's 30-day review.
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease that affects nerve cells in the brain and spinal cord resulting in a loss of muscle control.
The FDA's acceptance of the protocol amendment allows the commencement of clinical activities under the Sean M. Healey & AMG Center for ALS Investigational New Drug (IND). The first patients are expected to be enrolled early in 2026.
The HEALEY ALS Platform Trial, a multicentre, double-blind, placebo-controlled, adaptive trial for ALS, has been developed in partnership with the Network of Excellence for ALS (NEALS).
Sobi s Aspaveli marketing authorisation receives positive European regulatory opinion
BioCryst wins FDA approval for oral HAE prophylaxis in young children
NanOlogy launches drug development program for diffuse intrinsic pontine glioma treatment
Amgen's UPLIZNA receives US FDA approval
FDA grants priority review to Bristol Myers Squibb's Opdivo regimen for advanced Hodgkin lymphoma
Zydus Lifesciences enters licence and supply partnership with Formycon
Cereno Scientific's Phase IIb trial of CS1 in PAH approved by US FDA
ALR Technologies announces GluCurve Pet CGM relaunch in Canada
Mirum Pharmaceuticals to acquire Bluejay Therapeutics for HDV treatment
PureTech clears key FDA milestone for Phase 3 development of deupirfenidone
J & D Pharmaceuticals' investigational therapy for HCC receives US FDA Orphan Drug Designation