FDA gives Neurizon a faster route to approval as its pivotal ALS readout nears

The FDA has granted Neurizon Therapeutics a potential expedited approval path for its ALS drug NUZ-001 based on a single pivotal trial readout expected in mid-2027. The company completed enrollment for its Phase 2/3 trial rapidly and has secured funding through the trial readout, supported by NIH backing for expanded access to the drug.

This Wire brief sits within Fusion42's coverage of Biotech.