Latest Als Therapeutics News

The FDA says positive results from Neurizon’s HEALEY ALS trial could potentially support traditional approval of NUZ-001, with the study possibly serving as the sole registrational trial. The guidance is conditional, but gives the company a clearer regulatory route ahead of topline results expected in late Q2 2027.

Neurizon Therapeutics has announced the successful completion of its Open-Label Extension study for NUZ-001 in ALS, revealing significant survival benefits and strong tolerability. The company is on track to release top-line results in Q3 2025 and advance to a pivotal Phase 2/3 trial.