FDA grants RMAT designation to Candel's CAN-2409 for prostate cancer; phase 3 met endpoint

Candel Therapeutics, Inc.

RMAT designation for CAN-2409 (aglatimagene besadenovec) in newly diagnosed localized intermediate-to-high-risk prostate cancer.
Phase 3 trial met primary endpoint: 30% risk reduction in disease-free survival (HR 0.70; p=0.0155) vs placebo.
CAN-2409 improved prostate-specific DFS (38% risk reduction; p=0.0046) and pathological complete response (80.4% vs 63.6%; p=0.0015).
Previously granted Fast Track; BLA submission anticipated by end of 2026 with potential rolling/priority review.
Designation provides intensive FDA guidance to expedite development and review of the therapy.

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