---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-24-029205"
form_type: "8-K"
ticker: "CLNN"
cik: "0001822791"
company_name: "Clene Inc."
filed_at: "2024-09-16T23:59:59+00:00"
generated_at: "2026-05-31T04:40:22.493287+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Clene granted in-person FDA meeting to discuss CNM-Au8 ALS accelerated approval

## Summary
- FDA senior leadership meeting will occur before end of November 2024 to review CNM-Au8.
- DN1 previously deemed briefing package unsupportive of accelerated approval NDA, but FDA agreed to re-evaluate.
- Meeting includes Directors of Office of New Drugs, Office of Neuroscience, DN1, and ALS key opinion leaders.
- Over 700 patient-years of safety data with no SAEs attributed to CNM-Au8 by investigators.
- Clene believes biomarkers, clinical endpoints, and survival data support CNM-Au8 for ALS.

## SEC filing metadata
- accession: 0001437749-24-029205
- form_type: 8-K
- ticker: CLNN
- cik: 0001822791
- company_name: Clene Inc.
- filed_at: 2024-09-16T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- 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/1822791/000143774924029205/0001437749-24-029205-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1822791/000143774924029205/clnn20240912_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-24-029205
- JSON: https://secwatch.observer/filing/0001437749-24-029205.json
- Plain text: https://secwatch.observer/filing/0001437749-24-029205.txt

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