Clene Inc.’s (NASDAQ: CLNN) CNM-Au8(R) Delivers Significant Survival Benefits in New Analyses of Healey ALS Platform Trial Data
Clene's CNM-Au8® treatment was demonstrated to improve survival in ALS patients by up to 14.8 months. The findings come from a post hoc analysis of the HEALEY ALS Platform Trial, comparing CNM-Au8 to a concurrently enrolled control. Strong survival benefit was observed in patients meeting the planned criteria for Clene’s upcoming Phase 3 RESTORE-ALS trial. The company is preparing to submit a New Drug Application (“NDA”) to the FDA later this year for potential accelerated approval, and further regulatory discussions and a confirmatory Phase 3 trial are planned for mid-2025. Clene (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine…