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Neurizon Therapeutics Limited (ASX:NUZ)

ALERT: Price-sensitive ASX Announcement for NUZ
Current share price for NUZ : $0.086 0.002 (2.38%)+
Announcement
Release
6 Oct 2026 9:57AM
Price at Release
$0.084
Full Release
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Summary
Neurizon Therapeutics Limited announced that the US FDA’s written feedback to its Type C meeting request for NUZ-001 in ALS supports the company’s regulatory strategy, with the FDA stating that positive results from the Phase 2/3 HEALEY ALS Platform Trial could potentially support a traditional approval pathway and that the trial may serve as the single registrational study for a New Drug Application, subject to substantial evidence of effectiveness and supporting evidence. The FDA also agreed with Neurizon’s approach to measuring plasma neurofilament light chain as a biomarker and outlined what would be needed for it to support accelerated approval, while noting a strong scientific rationale would be required if the HEALEY primary endpoint is not met. Neurizon said Regimen I in the HEALEY trial is fully enrolled, topline results are expected in late Q2 calendar 2027, and the company remains focused on preparing an NDA for traditional approval, with biomarker data from HEALEY intended to support the application. The FDA also indicated Neurizon may resubmit a Fast Track Designation request, and the company noted a separate NIH-funded expanded access program is expected to begin in Q1 calendar 2027 to provide NUZ-001 to around 200 ALS patients in the US while generating longer-term safety and biomarker data.
Key Points
  • FDA provided written Type C feedback on NUZ-001’s clinical development plan and regulatory pathway in ALS.
  • FDA said positive results from the HEALEY ALS Platform Trial could potentially support a traditional approval pathway.
  • FDA said the HEALEY ALS Platform Trial may serve as the single registrational study for an NDA, subject to substantial evidence of effectiveness and supporting evidence.
  • FDA agreed with Neurizon’s approach to measuring plasma neurofilament light chain and outlined what would be needed for biomarker support of accelerated approval.
  • Neurizon’s regulatory strategy remains focused on preparing an NDA seeking traditional approval.
  • HEALEY Regimen I is fully enrolled with topline results expected in late Q2 CY2027.
  • FDA indicated Neurizon may resubmit a Fast Track Designation request.
  • An NIH-funded expanded access program for NUZ-001 is expected to commence in Q1 CY2027 for approximately 200 people with ALS in the US.
  • The announcement describes the HEALEY ALS Platform Trial as a multicentre, double-blind, placebo-controlled adaptive Phase 2/3 study conducted in the US.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.