secwatch.observer — SEC 8-K summary
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Issuer:     Clene Inc. (CLNN)
CIK:        0001822791
Form:       8-K
Filed at:   2024-08-06T23:59:59+00:00
Accession:  0001437749-24-024726
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Clene submits CNM-Au8 data to FDA: 57% survival benefit, 28% NfL reduction in ALS responders
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- CNM-Au8 NfL Responders (nearly half of treated) showed 28% mean NfL reduction vs. increase in non-responders (p<0.00001).
- CNM-Au8 30mg in HEALEY trial: 57% decreased mortality risk vs. PRO-ACT controls (HR 0.431, p=0.0002).
- CNM-Au8 30mg in RESCUE-ALS: 70% decreased mortality risk vs. PRO-ACT (HR 0.311, p=0.0035).
- NfL Responders showed significantly less ALSFRS-R decline at Weeks 64-100 (p<0.01 vs non-responders).
- FDA Type C interaction expected Q3 2024 to discuss accelerated approval pathway based on these results.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1822791/000143774924024726/0001437749-24-024726-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1822791/000143774924024726/clnn20240805_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-24-024726

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer