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Flagship application put on hold
Posted 21 January 2025 AM
Melbourne-based Neurizon Therapeutics has been hit with a setback from the FDA, which placed its Investigational New Drug (IND) application on hold on Friday.
The IND application, filed last month, is for NUZ-001, Neurizon's flagship product, and is needed for the drug to enter Phase 2 trials to treat Amyotrophic Lateral Sclerosis (ALS), also known as Motor Neuron Disease, as part of the HEALEY ALS Platform Trial. Neurizon had planned to start the trial in the first half of 2025.
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Posted 21 January 2025 AM
Melbourne-based Neurizon Therapeutics has been hit with a setback from the FDA, which placed its Investigational New Drug (IND) application on hold on Friday.
The IND application, filed last month, is for NUZ-001, Neurizon's flagship product, and is needed for the drug to enter Phase 2 trials to treat Amyotrophic Lateral Sclerosis (ALS), also known as Motor Neuron Disease, as part of the HEALEY ALS Platform Trial. Neurizon had planned to start the trial in the first half of 2025.
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