Neurizon Therapeutics (ASX:NUZ) received written responses from the US Food and Drug Administration (FDA) to its type C meeting request for NUZ-001, a treatment candidate for amyotrophic lateral sclerosis (ALS), affirming that positive results from its phase 2/3 trial may support a traditional approval pathway, according to a Tuesday Australian bourse filing.

The US FDA agreed with the company's approach to measuring plasma neurofilament light chain, a marker of nerve damage, and outlined the types of evidence that would be needed for neurofilament light chain to support accelerated approval.

The regulator noted that the trial may serve as the single registrational study for a new drug application, subject to meeting the requirement for substantial evidence of effectiveness, including supporting evidence alongside the study results.

The clinical-stage biotech company's shares rose nearly 5% in recent trading on Tuesday.