Clene Announces New Drug Application Submission to FDA for CNM-Au8 for the Treatment of ALS
Clene submitted a New Drug Application to the FDA in early October seeking accelerated approval of CNM-Au8 for amyotrophic lateral sclerosis. The filing is based on neurofilament light chain biomarker data and clinical outcomes; the company is simultaneously preparing the confirmatory Phase 3 RESTORE-ALS study.
Key figures
- Drug Name
- CNM-Au8
- Phase Of Trial
- Phase 3
- Indication
- amyotrophic lateral sclerosis (ALS)
- Approval pathway
- accelerated approval based on neurofilament light chain biomarker data and clinical outcomes
AI analysis
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