Clene submits FDA NDA for ALS drug CNM-Au8, seeking accelerated approval

Clene Inc.

• NDA submitted to FDA earlier in October 2026 for CNM-Au8 in ALS; Clene publicly announced the submission on October 19, 2026.
• Application seeks accelerated approval based on neurofilament light chain biomarker data plus clinical outcomes.
• CEO Rob Etherington cited the FDA's "constructive engagement" and said Clene will work closely with the agency during review.
• Clene says it continues preparations for the confirmatory Phase 3 RESTORE-ALS study while the NDA is pending.
• No PDUFA date or filing-acceptance decision disclosed; FDA must accept the application before substantive review begins.