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MHRA agreed that the use of comparable historical control data – derived from a systematic evaluation of all suitable available peer-reviewed literature by independent biostatistics advisors presented in its most recent
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The Company aligned with the FDA on the use of the proposed adaptive design agreed upon with the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) for the
Filed: 2026-09-10 AccNo: 0001213900-26-098880 Size: 269 KB Item 8.01: Other Events Item 9.01: Financial Statements and Exhibits
OS Therapies (NYSE: OSTX) interim Phase 2b trial data shows a 71.2% 3-year overall survival rate for OST-HER2 vs. 45.8% for controls.