Clene says FDA reviews CNM-Au8 NDA for ALS accelerated approval in early Q4 filing

PUBT · 1d ago
Clene says FDA reviews CNM-Au8 NDA for ALS accelerated approval in 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).


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Clene Inc. published the original content used to generate this news brief on August 10, 2026, and is solely responsible for the information contained therein.