OS Therapies Announces Its Phase 2b Trial Of OST-HER2 In The Prevention Or Delay Of Recurrence In Fully Resected, Pulmonary Metastatic Osteosarcoma Achieved Statistically Significant Benefit For OST-HER2 Treated Patients In Overall Survival At The...

OS Therapies Incorporated

OSTX

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75% 2.5-year overall survival for OST-HER2 vs. 47% pooled historical control (p = 0.003), with no new patient deaths reported since the 2-year overall survival data (75% vs. 60%, p = 0.034)
Updated clinical efficacy data being added to regulatory dossiers as Company seeks early market authorizations in U.S., U.K., Europe and Australia in 2nd half of 2026
EMA and Australia TGA (TGA) alignment achieved on early Q4-2026 3-year overall survival data, supported by biomarker data, as key approvable clinical efficacy endpoint
Upcoming U.S. FDA and U.K. MHRA meetings seek alignment with EMA and TGA on Phase 2b 3-year overall survival and biomarker data to support early market access
Confirmatory Phase 3 study, required to have commenced prior to grant of early market access in U.S., U.K., Europe or Australia, expected to initiate in late Q3-2026 in Australia

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