regulatory
confidence high
sentiment neutral
materiality 0.75
Clene granted in-person FDA meeting to discuss CNM-Au8 ALS accelerated approval
Clene Inc.
- FDA senior leadership meeting will occur before end of November 2024 to review CNM-Au8.
- DN1 previously deemed briefing package unsupportive of accelerated approval NDA, but FDA agreed to re-evaluate.
- Meeting includes Directors of Office of New Drugs, Office of Neuroscience, DN1, and ALS key opinion leaders.
- Over 700 patient-years of safety data with no SAEs attributed to CNM-Au8 by investigators.
- Clene believes biomarkers, clinical endpoints, and survival data support CNM-Au8 for ALS.