secwatch.observer — SEC 8-K summary
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Issuer:     Clene Inc. (CLNN)
CIK:        0001822791
Form:       8-K
Filed at:   2026-08-10T12:07:37+00:00
Accession:  0001437749-26-026653
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Clene reports biomarker analyses showing CNM-Au8 survival benefit in NfL responders for ALS NDA
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- CNM-Au8 30 mg cut death risk 74% at 12 months vs controls in HEALEY (p=0.0124); 38% lower risk over full follow-up (HR 0.621, p=0.037).
- Causal analysis: 41% lower death risk in predicted NfL responders (HR 0.593, p=0.026); no benefit in non-responders.
- RESCUE-ALS: NfL responders had 76% lower adjusted death risk vs non-responders (HR 0.24, p=0.008); median survival 43.5 vs 19.9 months.
- 10% NfL decline linked to 6-10% lower death risk in >2,000 untreated ALS patients (APST, ANSWER ALS).
- NDA for ALS accelerated approval planned for early Q4 2026; FDA acknowledged NfL as reasonably likely surrogate in March 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1822791/000143774926026653/0001437749-26-026653-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1822791/000143774926026653/clnn20260806_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-26-026653

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