Clene and NeuroSense advance ALS drug regulatory filings

Clene and NeuroSense Therapeutics are advancing regulatory efforts for treatments targeting amyotrophic lateral sclerosis (ALS).

Clene plans to submit a New Drug Application (NDA) for CNM-Au8 in early Q4 following discussions with the U.S. Food and Drug Administration. The company is focusing on neurofilament light (NfL) as a biomarker to support accelerated approval. Clene reported a 10% reduction in NfL and a 38% lower risk of death in survival analyses compared to concurrent controls.

NeuroSense Therapeutics aims to submit a New Drug Submission (NDS) for PrimeC in Canada by December 2026. This follows the completion of pre-application meetings with Health Canada. The submission will utilize data from the Phase 2b PARADIGM trial, which indicated a reduction in TDP-43 protein, increased median survival, and improved functional assessments.