Clinical TrialsThe RESTORE-ALS trial is an international, randomized, double-blind, placebo-controlled Phase 3 trial that aims to evaluate the effects of CNM-Au8 on survival and clinical worsening events in ALS patients.
Regulatory AdvancementClene's significant overall survival data across 3 studies indicates a positive outlook for FDA approval of CNM-Au8.
Regulatory ProcessThe FDA's willingness to review data from the Expanded Access Protocols is seen as a positive step, indicating a potential for accelerated approval.