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Clene Announces New Drug Application Submission to FDA for CNM-Au8 for the Treatment of ALS

GlobeNewswire Inc.·
Clene Announces New Drug Application Submission to FDA for CNM-Au8 for the Treatment of ALS

Clene Inc. (Nasdaq: CLNN) announced the submission of a New Drug Application (NDA) to the FDA in October 2026 seeking accelerated approval of CNM-Au8 for treating amyotrophic lateral sclerosis (ALS). The submission is based on neurofilament light chain biomarker data and clinical outcomes. The company plans to continue with a confirmatory Phase 3 RESTORE-ALS study while awaiting FDA review.

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