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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Business News
May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.