---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-25-021483"
form_type: "8-K"
ticker: "CLNN"
cik: "0001822791"
company_name: "Clene Inc."
filed_at: "2025-06-30T23:59:59+00:00"
generated_at: "2026-05-18T14:35:42.678821+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Clene receives constructive FDA feedback on NfL biomarker analysis plan; ALS NDA on track for Q4 2025

## Summary
- FDA provided supportive feedback on Clene's statistical analysis plan for neurofilament light (NfL) biomarker analysis from NIH-sponsored Expanded Access Program.
- NfL analyses to be conducted early Q4 2025; may support accelerated approval NDA submission for CNM-Au8 in ALS.
- Two additional FDA meetings scheduled in Q3 2025: ALS survival data Type C and End-of-Phase 2 MS program Type B.
- NDA submission under accelerated approval pathway remains on track for potential submission in Q4 2025.
- EAP supports nearly 200 ALS patients treated with compassionate use CNM-Au8; comparator group uses matched controls.

## SEC filing metadata
- accession: 0001437749-25-021483
- form_type: 8-K
- ticker: CLNN
- cik: 0001822791
- company_name: Clene Inc.
- filed_at: 2025-06-30T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1822791/000143774925021483/0001437749-25-021483-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1822791/000143774925021483/clnn20250627_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-021483
- JSON: https://secwatch.observer/filing/0001437749-25-021483.json
- Plain text: https://secwatch.observer/filing/0001437749-25-021483.txt

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