OS Therapies Granted U.S. FDA Type C Statistical Methods Meeting to Review 2.5-Year Overall Survival Data for OST-HER2 in the Prevention or Delay of Recurrence in Fully Resected, Pulmonary Metastatic Osteosarcoma
Meeting to occur in mid-September 2026 Interim 3-year Overall Survival data expected early September, 2026 Decisions on appropriate comparator arm to interpret OST-HER2 clinical efficacy, RMAT designation and Rolling Review expected following this meeting Sustained overall survival benefit observed between 2-year and 2.5-year timepoints U.K. MHRA Statistical Methods Scientific Advice Meeting granted in parallel New York, New York and Rockville, Maryland--(Newsfile Corp. - August 13, 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 the U.S. Food and Drug Administration (FDA) has granted the Company's requested Type C Statistical Methods meeting to review the 2.5 year overall survival data from the Phase 2b trial of OST-HER2 in the prevention of recurrence in fully resected, pulmonary metastatic osteosarcoma (the "Metastatic Osteosarcoma Trial"). The Company expects the FDA Type C Statistical Methods Meeting to occur in mid-September 2026 with members from division within the Center for Biologics Evaluation and Research (CBER), in parallel with the pending Biomarker Data Review Meeting being scheduled with members of the Center for Drug Evaluation and Research's (CDER) Biomarker Qualification Program (BQP).
