---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-24-024726"
form_type: "8-K"
ticker: "CLNN"
cik: "0001822791"
company_name: "Clene Inc."
filed_at: "2024-08-06T23:59:59+00:00"
generated_at: "2026-05-31T12:29:36.046366+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Clene submits CNM-Au8 data to FDA: 57% survival benefit, 28% NfL reduction in ALS responders

## Summary
- CNM-Au8 NfL Responders (nearly half of treated) showed 28% mean NfL reduction vs. increase in non-responders (p<0.00001).
- CNM-Au8 30mg in HEALEY trial: 57% decreased mortality risk vs. PRO-ACT controls (HR 0.431, p=0.0002).
- CNM-Au8 30mg in RESCUE-ALS: 70% decreased mortality risk vs. PRO-ACT (HR 0.311, p=0.0035).
- NfL Responders showed significantly less ALSFRS-R decline at Weeks 64-100 (p<0.01 vs non-responders).
- FDA Type C interaction expected Q3 2024 to discuss accelerated approval pathway based on these results.

## SEC filing metadata
- accession: 0001437749-24-024726
- form_type: 8-K
- ticker: CLNN
- cik: 0001822791
- company_name: Clene Inc.
- filed_at: 2024-08-06T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1822791/000143774924024726/0001437749-24-024726-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1822791/000143774924024726/clnn20240805_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-24-024726
- JSON: https://secwatch.observer/filing/0001437749-24-024726.json
- Plain text: https://secwatch.observer/filing/0001437749-24-024726.txt

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