Most Recent Events

• 24 Mar 2025 According to the Neurizon Therapeutics Media Release, Following the latest round of testing, updates to the Master Protocol have been included to enhance and optimise future learning within the trial based on data collected from the first 5 regimens. These changes allow to finalise its RSA under the Master Protocol for submission to the FDA as soon as the clinical hold on NUZ-001 has been lifted. Further information on the RSA for NUZ-001 will be provided following FDA acceptance in H2 CY2025.
• 24 Mar 2025 According to the Neurizon Therapeutics Media Release, Company will continue to work towards finalising participation in the HEALEY trial, with entry expected during H2 CY2025, which will include completing the two short-term pharmacokinetic studies required to lift the FDA clinical hold.
• 18 Mar 2025 According to the Neurizon Therapeutics Media Release, Company is addressing the FDA's clinical hold on IND application for NUZ-001 by initiating two short-term PK studies. These studies, designed to provide additional animal data, are in response to the FDA's request for clarification on systemic exposure adequacy. A formal FDA response is expected within 60 days, studies with an estimated duration of 4 months, aim to facilitate NUZ-001's entry into the HEALEY ALS study in 2nd half of 2025.