10:40 AM EDT, 05/28/2025 (MT Newswires) -- Candel Therapeutics ( CADL ) said Wednesday that the US Food and Drug Administration had granted Regenerative Medicine Advanced Therapy, or RMAT, designation to CAN-2409, its lead candidate, for the treatment of prostate cancer.

The decision was based on a phase 3 study evaluating the safety and efficacy of CAN-2409 plus valacyclovir, which met its primary endpoint and demonstrated "statistically significant improvement" in disease-free survival with a 30% reduction in the risk for prostate cancer recurrence.

The RMAT designation provides eligibility to develop mechanisms for Biologics License Application review and approval, the biopharmaceutical company said.

Candel shares rose by more than 10% in recent Wednesday trading.

Price: 6.16, Change: +0.56, Percent Change: +9.91