RegulatoryApr 30, 2026, 04:19 PM
OSTX: EMA Initiates Rolling Review for OST-HER2 CMA; EU Sales >$300M
AI Summary
OS Therapies Inc. announced the European Medicines Agency (EMA) initiated a rolling review for Conditional Marketing Authorization (CMA) of OST-HER2 for osteosarcoma. The company also received Advanced Therapy Medicinal Product (ATMP) designation from the U.K. MHRA and expects European peak sales for OST-HER2 to exceed $300 million, with over $50 million in sales by 2027. Regulatory alignment was achieved with EMA and Australia TGA on key efficacy endpoints and surrogate data, with upcoming meetings with U.S. FDA and U.K. MHRA in Q2 2026. The company also provided updates on its OST-504 and OST-503 pipeline candidates.
Key Highlights
- EMA initiated rolling review for OST-HER2 Conditional Marketing Authorization (CMA) for osteosarcoma.
- EMA and Australia TGA (ATGA) aligned on 3-year overall survival as approvable clinical efficacy endpoint.
- EMA and ATGA aligned on Seroconversion data as surrogate efficacy for CMAs and Priority Review Voucher eligibility.
- OST-HER2 granted Advanced Therapy Medicinal Product (ATMP) designation by U.K. MHRA.
- Company forecasts European peak OST-HER2 sales exceeding $300 million, with over $50 million in sales by 2027.
- Upcoming U.S. FDA and U.K. MHRA meetings scheduled for Q2 2026.
- OST-503 candidate indications expanded to include pancreatic cancer.
- Company anticipates potential EMA CMA decision in Q4 2026.