Clinical Trial ProgressThe confirmatory Phase 3 RESTORE-ALS trial aims to evaluate the effects of CNM-Au8 on survival and clinical worsening events in ALS, providing robust evidence for its efficacy.
FDA CollaborationClene's ongoing, significant dialogue with the FDA for the development of CNM-Au8 in ALS is a positive indication of potential favorable regulatory feedback.
Regulatory AdvancementsClene's CNM-Au8 has Orphan Drug Designation, qualifying it for a Priority Review by the FDA, enhancing its potential for accelerated approval.