OSTX biotech catalysts & pipeline

OS THERAPIES INC · Data as of 2026-09-08

Upcoming catalysts

OST-HER2 — FDA meeting

Sep 2026

We anticipate submitting the clinical Biologics License Application (BLA) module following an expected Type C meeting with the FDA in the September 2026 and completing conditional Marketing Authorization Application (MAA) submissions to both the MHRA and the EMA in the first quarter of 2027.

Source filing

OST-HER2 — Interim data

Oct 2026

We also anticipate releasing additional biomarker data in October 2026 to further characterize immune pathway activation and its relationship to clinical outcomes.

Source filing

OST-HER2 — Regulatory decision

Q4 2026

The Company anticipates a potential CMA decision by EMA in the fourth quarter of 2026.

Source filing

OST-HER2 — NDA/BLA submission

Q1 2027

We anticipate submitting the clinical Biologics License Application (BLA) module following an expected Type C meeting with the FDA in the September 2026 and completing conditional Marketing Authorization Application (MAA) submissions to both the MHRA and the EMA in the first quarter of 2027.

Source filing

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