secwatch.observer — SEC 8-K summary
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Issuer:     Clene Inc. (CLNN)
CIK:        0001822791
Form:       8-K
Filed at:   2024-09-16T23:59:59+00:00
Accession:  0001437749-24-029205
Event type: regulatory
Sentiment:  neutral
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Clene granted in-person FDA meeting to discuss CNM-Au8 ALS accelerated approval
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- FDA senior leadership meeting will occur before end of November 2024 to review CNM-Au8.
- DN1 previously deemed briefing package unsupportive of accelerated approval NDA, but FDA agreed to re-evaluate.
- Meeting includes Directors of Office of New Drugs, Office of Neuroscience, DN1, and ALS key opinion leaders.
- Over 700 patient-years of safety data with no SAEs attributed to CNM-Au8 by investigators.
- Clene believes biomarkers, clinical endpoints, and survival data support CNM-Au8 for ALS.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1822791/000143774924029205/0001437749-24-029205-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1822791/000143774924029205/clnn20240912_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-24-029205

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