---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-25-078079"
form_type: "8-K"
ticker: "CADL"
cik: "0001841387"
company_name: "Candel Therapeutics, Inc."
filed_at: "2025-05-28T23:59:59+00:00"
generated_at: "2026-05-20T08:36:24.419386+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA grants RMAT designation to Candel's CAN-2409 for prostate cancer; phase 3 met endpoint

## Summary
- RMAT designation for CAN-2409 (aglatimagene besadenovec) in newly diagnosed localized intermediate-to-high-risk prostate cancer.
- Phase 3 trial met primary endpoint: 30% risk reduction in disease-free survival (HR 0.70; p=0.0155) vs placebo.
- CAN-2409 improved prostate-specific DFS (38% risk reduction; p=0.0046) and pathological complete response (80.4% vs 63.6%; p=0.0015).
- Previously granted Fast Track; BLA submission anticipated by end of 2026 with potential rolling/priority review.
- Designation provides intensive FDA guidance to expedite development and review of the therapy.

## SEC filing metadata
- accession: 0000950170-25-078079
- form_type: 8-K
- ticker: CADL
- cik: 0001841387
- company_name: Candel Therapeutics, Inc.
- filed_at: 2025-05-28T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1841387/000095017025078079/0000950170-25-078079-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1841387/000095017025078079/cadl-20250528.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-25-078079
- JSON: https://secwatch.observer/filing/0000950170-25-078079.json
- Plain text: https://secwatch.observer/filing/0000950170-25-078079.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.