OS Therapies announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) will lead the global regulatory review for its OST-HER2 cancer immunotherapy under Project Orbis. The MHRA's alignment enables the upcoming submission of a Conditional Marketing Authorisation Application (CMAA) and the initiation of a confirmatory Phase 3 trial in the UK by mid-2026. This leadership role facilitates coordinated regulatory efforts with the US FDA and EMA, supported by access to the UK national patient registry to enhance data analysis. The company aims to expand the Phase 3 trial globally and pursue approvals in the US, Europe, and Australia, with potential Priority Review Voucher benefits if approved by the FDA.
OS Therapies' regulatory update is provided here with Pluang's Health sector market data as of Sep 21, 2026 17:21 WIB: Of 92 priced US Health stocks on Pluang, 46 advanced and 29 declined today. Notable movers include Summit Therapeutics Inc (SMMT) at USD 18.61, up 4.26%, AbCellera Biologics Inc (ABCL) at USD 13.07, up 3.48%, and Citius Pharmaceuticals Inc (CTXR) at USD 0.58, down 3.33%.
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