Candel Therapeutics: FDA Grants RMAT Designation To CAN-2409

(RTTNews) - Candel Therapeutics (CADL) announced the FDA has granted Regenerative Medicine Advanced Therapy designation to CAN-2409, the company's biological immunotherapy lead candidate, for the treatment of newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk disease. The RMAT designation was granted on the basis of the positive data from phase 3 randomized, placebo-controlled clinical trial. CAN-2409 was also previously granted FDA Fast Track designation for the same indication.

"We look forward to collaborating with the FDA to pursue an expeditious approval of CAN-2409 once we submit our BLAcurrently anticipated at the end of 2026," said Paul Peter Tak, President and CEO of Candel.

Shares of Candel Therapeutics are up 3% in pre-market trade on Wednesday.

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