When will the FDA approve CNM-Au8?

As Phase 2 clinical trials testing CNM-Au8 have shown promising results in people with amyotrophic lateral sclerosis (ALS), Clene Nanomedicine, the company developing CNM-Au8, now is planning to launch a Phase 3 trial to confirm the benefits of the liquid suspension in a larger population of patients. Data from this trial, called RESTORE-ALS, may support an application to the U.S. Food and Drug Administration, but it is still too early to know if or when the medication might be approved.