Candel Therapeutics Inc., a clinical-stage biopharmaceutical company, has achieved a significant regulatory milestone with the European Medicines Agency $(EMA)$ granting Orphan Designation for their innovative immunotherapy, CAN-2409, for the treatment of pancreatic cancer. This recognition complements prior designations from the U.S. Food and Drug Administration (FDA), including Orphan Drug and Fast Track Designations for pancreatic ductal adenocarcinoma (PDAC). The EMA's Orphan Designation is particularly noteworthy as it highlights the significant unmet medical need for effective treatments for pancreatic cancer in the European Union, offering Candel Therapeutics benefits such as reduced regulatory fees and up to 10 years of market exclusivity if approved. This development underscores the transformative potential of CAN-2409 and Candel's commitment to advancing cancer treatment options globally.
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