Candel Therapeutics receives EMA Orphan Designation for CAN-2409

Candel Therapeutics (CADL) announced that the European Medicines Agency, EMA, has granted Orphan Designation for CAN-2409 for the treatment of pancreatic cancer. This designation complements CAN-2409’s existing U.S. Food and Drug Administration, FDA, Orphan Drug Designation and FDA Fast Track Designation for the treatment of pancreatic ductal adenocarcinoma, PDAC, awarded to CAN-2409 in April 2024 and December 2023, respectively. “Receiving EMA Orphan Designation for CAN-2409 represents a significant regulatory milestone for CAN-2409 in this disease,” said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. “This designation, alongside our existing FDA Orphan Drug and Fast Track Designations for CAN-2409 in PDAC, underscores the promise of our novel multimodal immunotherapy approach… We look forward to continuing our development efforts and working with regulatory authorities across the world to make this innovative therapy available to patients in need.”