secwatch.observer — SEC 8-K summary
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Issuer:     Candel Therapeutics, Inc. (CADL)
CIK:        0001841387
Form:       8-K
Filed at:   2024-12-11T23:59:59+00:00
Accession:  0001193125-24-274870
Event type: other_material
Sentiment:  positive
Materiality: 0.90
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Candel's CAN-2409 meets phase 3 prostate cancer endpoint; BLA submission targeted for Q4 2026
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- Phase 3 trial met primary endpoint: DFS improvement with HR 0.7 (p=0.0155) vs placebo in intermediate-to-high risk localized prostate cancer.
- 14.5% relative improvement in DFS at 54 months; 80.4% pathological complete responses at 2-year biopsy vs 63.6% in control (p=0.0015).
- Phase 2b trial in low-to-intermediate risk active surveillance patients showed numerical improvement but did not reach statistical significance.
- Company intends to initiate FDA discussions and submit Biologics License Application for CAN-2409 in Q4 2026; trial conducted under SPA.
- Safety profile consistent with prior studies; most common adverse events were mild-to-moderate flu-like symptoms, fever, and chills.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1841387/000119312524274870/0001193125-24-274870-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1841387/000119312524274870/d901922d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-274870

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