Flagship application put on hold

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.

"While this is an unexpected development, we understand that such steps can arise during regulatory review processes," Neurizon CEO and MD, Dr Michael Thurn, said.