---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-032882"
form_type: "8-K"
ticker: "CLNN"
cik: "0001822791"
company_name: "Clene Inc."
filed_at: "2026-10-19T12:05:16+00:00"
generated_at: "2026-10-19T12:10:15.183845+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001437749-26-032882
- form_type: 8-K
- ticker: CLNN
- cik: 0001822791
- company_name: Clene Inc.
- filed_at: 2026-10-19T12:05:16+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1822791/000143774926032882/0001437749-26-032882-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1822791/000143774926032882/clnn20261019_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-032882
- JSON: https://secwatch.observer/filing/0001437749-26-032882.json
- Plain text: https://secwatch.observer/filing/0001437749-26-032882.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.