OS Therapies accepts FDA CDER meeting request to review OST-HER2 biomarker data

OS Therapies Incorporated

OS Therapies Incorporated

OSTX

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  • OS Therapies accepted an FDA CDER meeting request to review patent-pending pharmacodynamic biomarker data for OST-HER2 under the BEST program.
  • Meeting expected in summer 2026, running in parallel with a CBER Type B statistical methods meeting on 2.5-year survival data.
  • Company targets an Accelerated Approval BLA filing for OST-HER2 in early fall 2026, with year-end 2026 approval goal in the US.
  • Interim 3-year overall survival data expected in summer 2026, ahead of final 3-year data planned for the BLA.


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