OS Therapies, Inc. (OSTX) announced that the European Medicines Agency’s Committee for Advanced Therapy (CAT) has begun a rolling review of the company’s Conditional Marketing Authorization (CMA) dossier for OST‑HER2, a gene‑edited, listeria‑based immunotherapy designed to prevent recurrence in fully resected pulmonary metastatic osteosarcoma.
The EMA review is part of a coordinated global strategy that also includes the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the Australian Therapeutic Goods Administration (TGA). OS Therapies expects the EMA to complete its assessment and issue a CMA decision in the fourth quarter of 2026, with the UK and Australia following a similar timeline.
The rolling review allows the EMA to evaluate data as it becomes available, potentially accelerating the overall approval process. OS Therapies has already submitted 2‑year overall survival data showing a 75% survival rate versus a 40% historical control, and will provide 2.5‑year and 3‑year survival data in the coming quarters to support the CMA application.
OST‑HER2 has received Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation from the U.S. FDA, and similar designations from the EMA and UK MHRA, which can expedite development and review. The company projects European peak sales exceeding $300 million and expects sales of more than $50 million in 2027, underscoring the commercial potential of the product once regulatory approval is obtained.
The EMA rolling review represents a significant regulatory milestone that de‑risks OST‑HER2’s path to market and positions OS Therapies to capitalize on a rare and aggressive disease with an unmet medical need, while aligning with the company’s global regulatory strategy.
The content on EveryTicker is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.