Clinical Trial ResultsThe Phase 3 trial for CAN-2409 met the primary endpoint of disease-free survival with a 30% decrease in disease recurrence, setting the stage for a BLA filing.
Market PotentialBroad support from payors is already emerging, driven by the drug’s potential to delay or avoid long-term androgen deprivation therapy, a key cost and quality-of-life burden.
Regulatory AdvancementsCAN-2409 has received Regenerative Medicine Advanced Therapy and Fast Track designations from the FDA for the treatment of newly diagnosed localized prostate cancer in patients at intermediate-to-high-risk.