---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-24-022529"
form_type: "8-K"
ticker: "CLNN"
cik: "0001822791"
company_name: "Clene Inc."
filed_at: "2024-07-11T23:59:59+00:00"
generated_at: "2026-05-31T21:49:25.017437+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Clene to submit FDA briefing book for CNM-Au8 accelerated approval in ALS by July 13

## Summary
- Briefing book submission due July 13, 2024, for Type C interaction with FDA in Q3 2024.
- New post-hoc analyses include NfL biomarker reduction, survival data, and mechanism-of-action evidence.
- Data designed to address prior FDA comments from December 2023 meeting on accelerated approval path.
- Clene plans to disclose topline FDA feedback after the Type C interaction concludes.

## SEC filing metadata
- accession: 0001437749-24-022529
- form_type: 8-K
- ticker: CLNN
- cik: 0001822791
- company_name: Clene Inc.
- filed_at: 2024-07-11T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1822791/000143774924022529/0001437749-24-022529-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1822791/000143774924022529/clnn20240711_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-24-022529
- JSON: https://secwatch.observer/filing/0001437749-24-022529.json
- Plain text: https://secwatch.observer/filing/0001437749-24-022529.txt

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