Neurizon Therapeutics Limited (ASX:NUZ) Receives FDA Guidance on NUZ-001 IND Application
FDA Guidance
The FDA has provided further clarification on Neurizon Therapeutics Limited’s IND application for NUZ-001, requesting additional animal exposure data to assess systemic exposure in previous studies. Neurizon is evaluating the impact of this request on the timeline of its planned ALS clinical trial. The FDA did not specify any safety concerns arising from previous clinical studies using NUZ-001.
Executive Comments
Managing Director and Chief Executive Officer Dr. Michael Thurn stated, “We appreciate the FDA’s guidance and are pleased that the FDA has responded with only one straightforward request for additional information. This request focuses on enhancing and ensuring confidence in the previous animal safety data generated for NUZ-001 used in veterinary applications.
Neurizon considers that it is well-positioned to meet the FDA’s additional request. With established regulatory and scientific expertise, strong industry partnerships, and an open and constructive relationship with the FDA, we will work swiftly to generate the requested information to further strengthen the regulatory package for NUZ-001’s clinical development. We remain committed to advancing NUZ-001 as an effective potential treatment for ALS and other neurodegenerative diseases.”
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