Agenus Inc. has announced ongoing regulatory engagement with the FDA to expedite the approval process for its investigational medicines targeting cancer. In collaboration with Dr. Makary and senior U.S. government stakeholders, Agenus is pursuing expedited regulatory mechanisms such as Accelerated Approval, the Commissioner's National Priority Voucher Program, and Real-Time Oncology Review. This strategic effort aims to address the current cancer crisis by facilitating quicker access to potentially life-saving treatments. Additionally, Agenus is set to initiate the Phase 3 registrational trial, BATTMAN, for its BOT/BAL treatment in Q4 2025, following alignment with the FDA on its core design. This trial marks a significant step toward the potential registration of BOT/BAL, which has shown promising results in previous studies.
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