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FDA lifts hold on Aussie drug
Posted 7 October 2025 PM
The FDA has lifted a hold placed on an Investigational New Drug application by an Australian company, clearing the way for it to enter Phase 2/3 trials.
Neurizon Therapeutics had hoped to join the HEALEY ALS Platform trial in the first half of this year, to treat Amyotrophic Lateral Sclerosis (ALS), also known as Motor Neuron Disease. It applied for an Investigational New Drug (IND) designation for its flagship product NUZ-001 from the FDA in December last year, but in January the FDA placed a hold on it.
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Posted 7 October 2025 PM
The FDA has lifted a hold placed on an Investigational New Drug application by an Australian company, clearing the way for it to enter Phase 2/3 trials.
Neurizon Therapeutics had hoped to join the HEALEY ALS Platform trial in the first half of this year, to treat Amyotrophic Lateral Sclerosis (ALS), also known as Motor Neuron Disease. It applied for an Investigational New Drug (IND) designation for its flagship product NUZ-001 from the FDA in December last year, but in January the FDA placed a hold on it.
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