On December 29, 2025, INOVIO Pharmaceuticals, Inc. announced the FDA’s acceptance of its BLA for INO-3107 for RRP treatment.
Key Highlights:
FDA assigned a PDUFA review goal date of October 30, 2026.INO-3107 BLA filed under the accelerated approval pathway.FDA noted potential review issue with accelerated approval eligibility.INOVIO plans to meet with FDA to discuss accelerated approval eligibility.INO-3107 aims to reduce surgeries for RRP patients, improving quality of life.
Original SEC Filing: INOVIO PHARMACEUTICALS, INC. [ INO ] – 8-K – Dec. 29, 2025
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