---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-24-037061"
form_type: "8-K"
ticker: "CLNN"
cik: "0001822791"
company_name: "Clene Inc."
filed_at: "2024-12-10T23:59:59+00:00"
generated_at: "2026-05-29T05:15:26.067134+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA provides roadmap for accelerated approval of Clene's CNM-Au8 in ALS via additional NfL biomarker data

## Summary
- FDA recommends leveraging additional NfL data from three Expanded Access Protocols and HEALEY trial to support accelerated approval; follow-up meeting early 2025.
- Additional NfL biomarker analyses planned to complete Q2 2025; NDA submission targeted mid-2025.
- Confirmatory Phase 3 RESTORE-ALS trial to start enrollment before NDA submission, evaluating survival benefit.
- Key survival data from November meeting: 78% risk reduction in time to death at Month 12 (HR=0.224, p=0.042).
- Over 700 patient-years of CNM-Au8 use with no significant safety concerns; no SAEs related to treatment.

## SEC filing metadata
- accession: 0001437749-24-037061
- form_type: 8-K
- ticker: CLNN
- cik: 0001822791
- company_name: Clene Inc.
- filed_at: 2024-12-10T23:59:59+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/1822791/000143774924037061/0001437749-24-037061-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1822791/000143774924037061/clnn20241209_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-24-037061
- JSON: https://secwatch.observer/filing/0001437749-24-037061.json
- Plain text: https://secwatch.observer/filing/0001437749-24-037061.txt

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