---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-043532"
form_type: "8-K"
ticker: "CADL"
cik: "0001841387"
company_name: "Candel Therapeutics, Inc."
filed_at: "2024-04-11T23:59:59+00:00"
generated_at: "2026-06-04T00:09:26.467974+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Candel Therapeutics receives FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer

## Summary
- FDA granted Orphan Drug Designation for CAN-2409 (multimodal immunotherapy) in pancreatic cancer.
- Fast Track Designation also previously granted; both designations support development.
- Phase 2 data showed median OS 28.8 mo (CAN-2409+SoC) vs 12.5 mo (SoC alone); 24-mo survival 71.4% vs 16.7%.
- No new safety signals; CAN-2409 generally well tolerated with no pancreatitis or DLTs.
- Orphan Drug status provides tax credits, fee waivers, and 7-year market exclusivity if approved.

## SEC filing metadata
- accession: 0000950170-24-043532
- form_type: 8-K
- ticker: CADL
- cik: 0001841387
- company_name: Candel Therapeutics, Inc.
- filed_at: 2024-04-11T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1841387/000095017024043532/0000950170-24-043532-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1841387/000095017024043532/cadl-20240411.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-043532
- JSON: https://secwatch.observer/filing/0000950170-24-043532.json
- Plain text: https://secwatch.observer/filing/0000950170-24-043532.txt

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