Clene says FDA reviews CNM-Au8 NDA for ALS accelerated approval in early Q4 filing
CLNN•FDA review of CNM-Au8 NDA for ALS accelerated approval
Clene says the FDA is reviewing CNM-Au8 in an NDA for accelerated approval in ALS in an early Q4 filing.
- Clene plans to include new neurofilament light chain biomarker analyses in an NDA seeking FDA accelerated approval for CNM-Au8 in ALS.
- FDA raised questions in a March 2026 Type C meeting; the agency acknowledged NfL could potentially support accelerated approval as a surrogate endpoint.
- Post hoc Phase 2 analyses linked NfL decline or stabilization on CNM-Au8 to longer survival versus concurrently randomized controls in HEALEY (HR 0.621; p=0.037).
