As the U.S. Food and Drug Administration (FDA) proposed, Clene is concluding analyses of its ALS biomarker data with completion planned shortly The FDA advised Clene to request a Type C meeting to review these further ALS biomarker data analysesThe Company plans to submit a New Drug Application (NDA) in the first quarter of 2026 under an accelerated approval pathwayThe Company expects to have the first patient dosed in the confirmatory Phase 3 RESTORE-ALS trial of CNM-Au8 in the first half of 2026The FDA an ...