regulatory
confidence high
sentiment negative
materiality 0.85
FDA advises IO Biotech not to submit BLA for Cylembio; workforce cut by ~50%
IO Biotech, Inc.
- FDA recommends against BLA submission based on IOB-013 trial data (PFS improved but missed statistical significance).
- Company plans new registrational study for first-line advanced melanoma; also engaging European regulators.
- Restructuring reduces workforce ~50%; expects $1.0-1.5M severance charges in Q3 2025.
- Cash runway extended into Q1 2026 to focus on regulatory path for Cylembio.
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