IO Biotech (NASDAQ:IOBT) received a setback as the FDA recommended against submitting a Biologics License Application (BLA) for Cylembio based on the IOB-013 clinical trial data. The trial, which evaluated Cylembio plus pembrolizumab, showed improved progression-free survival (PFS) but narrowly missed statistical significance.
The company plans to design a new registrational study and will continue discussions with FDA and European regulators. In response, IO Biotech is implementing a restructuring plan, including a 50% workforce reduction. The company expects to incur a $1.0-$1.5 million restructuring charge in Q3 2025 and has capital to operate into Q1 2026.
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