---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-026653"
form_type: "8-K"
ticker: "CLNN"
cik: "0001822791"
company_name: "Clene Inc."
filed_at: "2026-08-10T12:07:37+00:00"
generated_at: "2026-08-10T12:10:28.522961+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Clene reports biomarker analyses showing CNM-Au8 survival benefit in NfL responders for ALS NDA

## Summary
- CNM-Au8 30 mg cut death risk 74% at 12 months vs controls in HEALEY (p=0.0124); 38% lower risk over full follow-up (HR 0.621, p=0.037).
- Causal analysis: 41% lower death risk in predicted NfL responders (HR 0.593, p=0.026); no benefit in non-responders.
- RESCUE-ALS: NfL responders had 76% lower adjusted death risk vs non-responders (HR 0.24, p=0.008); median survival 43.5 vs 19.9 months.
- 10% NfL decline linked to 6-10% lower death risk in >2,000 untreated ALS patients (APST, ANSWER ALS).
- NDA for ALS accelerated approval planned for early Q4 2026; FDA acknowledged NfL as reasonably likely surrogate in March 2026.

## SEC filing metadata
- accession: 0001437749-26-026653
- form_type: 8-K
- ticker: CLNN
- cik: 0001822791
- company_name: Clene Inc.
- filed_at: 2026-08-10T12:07:37+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/1822791/000143774926026653/0001437749-26-026653-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1822791/000143774926026653/clnn20260806_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-026653
- JSON: https://secwatch.observer/filing/0001437749-26-026653.json
- Plain text: https://secwatch.observer/filing/0001437749-26-026653.txt

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