OS Therapies Announces Full Alignment with UK MHRA and EU EMA for Conditional Marketing Authorisation Application Filing
Overall Survival (OS) historical-control data gains HMRA and EMA support for pending CMAA submissions Full alignment achieved on confirmatory Phase 3 trial design Complete CMAA submission expected in coming weeks New York, New York and Rockville, Maryland--(Newsfile Corp. - September 15, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or the "Company"), the world leader in gene-edited, Listeria-based cancer immunotherapies, today announced that it has achieved full alignment with the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) on its pending Conditional Marketing Authorisation Application (CMAA). 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 Scientific Advice Meeting (SAM) - was appropriate in the orphan indication Prevention or Delay of Recurrence in Fully Resected, Pulmonary Metastatic Osteosarcoma.