secwatch.observer — SEC 8-K summary
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Issuer:     Eledon Pharmaceuticals, Inc. (ELDN)
CIK:        0001404281
Form:       8-K
Filed at:   2025-11-07T23:59:59+00:00
Accession:  0001193125-25-270286
Event type: other_material
Sentiment:  neutral
Materiality: 0.80
Item codes: 2.02, 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Eledon Phase 2 BESTOW trial: tegoprubart eGFR 69 vs tacrolimus 66, primary endpoint not met but safety superior
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- Primary efficacy endpoint (eGFR at 12 months) did not reach statistical significance: 69 vs 66 mL/min/1.73 m².
- New-onset diabetes 1/47 on tegoprubart vs ~1/6 on tacrolimus; tremor 1.6% vs 25.0%; delayed graft function 14.3% vs 25.0%.
- Efficacy failure composite (death, graft loss, BPAR) was 22% tegoprubart vs 17% tacrolimus, meeting non-inferiority margin.
- Cash, equivalents, and short-term investments approximately $93.4M as of Sept 30, 2025, expected to fund operations to late 2026.
- Company plans to advance tegoprubart into Phase 3 after regulatory discussions on study design and data requirements.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1404281/000119312525270286/0001193125-25-270286-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1404281/000119312525270286/eldn-20251106.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-270286

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