Clene submits CNM-Au8 new drug application to FDA for ALS
Clene announced submission of a new drug application to the FDA for CNM-Au8, intended to treat ALS.
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12:04:26 PM UTC
SquawkNews
Clene submitted a New Drug Application to the FDA seeking accelerated approval of CNM-Au8 for treating ALS and is preparing the confirmatory Phase 3 RESTORE-ALS study.Material DetailsContext by AI AnalystThis is a late-stage regulatory step following prior clinical work on CNM-Au8 in ALS. A formal…