• FDA denies Fast Track Designation request for NUZ-001 at this stage
• Constructive feedback from FDA on additional data required to support future request
• NUZ-001 advances to next phase of HEALEY ALS Platform Trial with first patient enrollment expected soon
• Sufficient funding secured to complete pivotal registration-adaptive Phase 2/3 trial

Neurizon Therapeutics Limited, a clinical-stage biotech company focused on neurodegenerative diseases, has provided an update on the regulatory and clinical development status of its investigational new treatment for Amyotrophic Lateral Sclerosis (ALS), NUZ-001. The company has received regulatory correspondence from the US Food and Drug Administration (FDA) stating that its request for Fast Track Designation has been denied at this time. However, the FDA confirmed that ALS represents a serious condition with an unmet medical need and provided constructive feedback outlining the additional data that could support a future Fast Track Designation request as NUZ-001 advances through clinical development. Based on NUZ-001's current stage of development, the FDA indicated that additional clinical information would be required to demonstrate its differentiation from other FDA approved therapies. Neurizon views this feedback as providing a clear regulatory pathway and will assess the additional data requirements as it continues to progress NUZ-001 and evaluates the timing of a subsequent new Fast Track Designation request. The company also reports that NUZ-001 has advanced to the next operational phases of the HEALEY ALS Platform Trial, with activities underway, including Institutional Review Board (IRB) submissions, clinical site activation, and associated study start-up activities. Neurizon expects the first patients to be enrolled very early this year, representing an important near-term clinical milestone. This progress follows Neurizon's recent announcement that it has secured sufficient funding to complete the pivotal registration-adaptive Phase 2/3 clinical trial, providing clear visibility through to key clinical outcomes.