OS Therapies Inc. announced that its pre‑Marketing Authorization Application (MAA) meeting with the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) on its OST‑HER2 Phase 2b trial was successful. The meeting took place on December 8, 2025, and the company disclosed the outcome on December 9, 2025.
During the session, OS Therapies achieved full alignment with its pre‑meeting objectives on non‑clinical data, chemistry, manufacturing and controls (CMC), and the design of a post‑market confirmatory study. The company also advanced the use of immune‑response biomarkers derived from canine studies as a surrogate endpoint, a key element that could support a conditional MAA in the UK.
OS Therapies plans to submit a conditional MAA to the MHRA by the end of January 2026. It also has an upcoming Type C meeting with the U.S. Food and Drug Administration scheduled for December 11, 2025, where it will discuss the biomarker strategy and the path toward a Biologics Licensing Application under the Accelerated Approval Program.
The successful UK meeting represents a critical regulatory milestone that de‑risks the pathway to approval in the United Kingdom and, by extension, the European market. By securing alignment on non‑clinical data and confirmatory study design, OS Therapies is positioning OST‑HER2 for a conditional approval that leverages its strong overall survival data from the Phase 2b trial. The biomarker strategy, validated in canine models, could accelerate regulatory review and provide a surrogate endpoint that satisfies both UK and U.S. regulators, supporting a coordinated global submission strategy under Project Orbis.
Paul Romness, Chairman and CEO of OS Therapies, said, “We were pleased with the insightful feedback from our colleagues at UK MHRA during yesterday’s pre‑MAA meeting. Their perspective will be very helpful as we finalize preparations for our upcoming Type C Meeting with US FDA on Thursday.”
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