---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-014542"
form_type: "8-K"
ticker: "CLNN"
cik: "0001822791"
company_name: "Clene Inc."
filed_at: "2026-05-04T23:59:59+00:00"
generated_at: "2026-05-15T00:00:18.009718+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Clene announces FDA agrees CNM-Au8 data may support accelerated approval NDA for ALS

## Summary
- FDA stated proposed data may support NDA submission under accelerated approval pathway for ALS.
- FDA acknowledged NfL could potentially serve as a reasonably likely surrogate endpoint to support accelerated approval.
- Clene expects to submit NDA for CNM-Au8 in Q3 2026; Phase 3 confirmatory study to start Q1 2027.
- NDA supported by NfL and clinical data from Phase 2 trials and NIH-sponsored Expanded Access Protocol.
- CNM-Au8 previously received Orphan Drug Designation from FDA for ALS treatment.

## SEC filing metadata
- accession: 0001437749-26-014542
- form_type: 8-K
- ticker: CLNN
- cik: 0001822791
- company_name: Clene Inc.
- filed_at: 2026-05-04T23:59:59+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/1822791/000143774926014542/0001437749-26-014542-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1822791/000143774926014542/clnn20260503_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-014542
- JSON: https://secwatch.observer/filing/0001437749-26-014542.json
- Plain text: https://secwatch.observer/filing/0001437749-26-014542.txt

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