---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-001049"
form_type: "8-K"
ticker: "CLNN"
cik: "0001822791"
company_name: "Clene Inc."
filed_at: "2026-01-12T23:59:59+00:00"
generated_at: "2026-05-16T10:56:20.542602+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Clene reports CNM-Au8 biomarker data supporting potential accelerated approval; FDA meeting in Q1 2026

## Summary
- FDA granted in-person Type C meeting in Q1 2026 to discuss CNM-Au8 regulatory path for ALS.
- New analyses across ALS cohorts show ~10% NfL reduction associated with 8-13% lower mortality risk.
- In HEALEY trial, IGFBP7 responders to CNM-Au8 30mg had 78% mortality risk reduction (HR 0.22, p=0.01).
- CNM-Au8 consistently reduced NfL: HEALEY Week 24 GMR 0.905 (p=0.04) and NIH EAP Week 36 AUC diff -0.090 (p=0.037).
- Genetic variant linked to lower IGFBP7 expression correlates with ALS reversals, supporting CNM-Au8 mechanism.

## SEC filing metadata
- accession: 0001437749-26-001049
- form_type: 8-K
- ticker: CLNN
- cik: 0001822791
- company_name: Clene Inc.
- filed_at: 2026-01-12T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1822791/000143774926001049/0001437749-26-001049-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1822791/000143774926001049/clnn20260109_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-001049
- JSON: https://secwatch.observer/filing/0001437749-26-001049.json
- Plain text: https://secwatch.observer/filing/0001437749-26-001049.txt

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