Candel Therapeutics receives FDA regenerative medicine advanced therapy designation for CAN-2409 for the treatment of prostate cancer

Candel Therapeutics

28 May 2025 - Candel Therapeutics today announced that the US FDA has granted regenerative medicine advanced therapy designation to CAN-2409 (aglatimagene besadenovec), the Company’s biological immunotherapy lead candidate, for the treatment of newly diagnosed localised prostate cancer in patients with intermediate to high risk disease. 

CAN-2409 was also previously granted FDA fast track designation for the same indication.

Read Candel Therapeutics press release

Michael Wonder

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Michael Wonder