Core Viewpoint - OS Therapies has successfully completed a pre-Marketing Authorisation Application meeting with the UK MHRA for its Phase 2b clinical trial of OST-HER2, aimed at preventing or delaying recurrent pulmonary metastatic osteosarcoma [2][4] Group 1: Clinical Trial and Regulatory Progress - The company achieved full alignment on key points regarding non-clinical, chemistry, manufacturing, and controls (CMC), and post-market authorization confirmatory study design during the pre-MAA meeting [6] - The company plans to submit a conditional MAA for the Metastatic Osteosarcoma Program to the MHRA by the end of January 2026 [4][6] - A meeting with the US FDA is scheduled for December 11, 2025, to discuss biomarker data analysis, which is crucial for supporting a Biologics Licensing Application under the Accelerated Approval Program [3][6] Group 2: Clinical Efficacy and Future Plans - The Phase 2b clinical trial of OST-HER2 demonstrated statistically significant benefits in the 12-month event-free survival primary endpoint [7] - The company anticipates submitting a Biologics Licensing Application to the US FDA for OST-HER2 in osteosarcoma in the first quarter of 2026, which could lead to eligibility for a Priority Review Voucher [7] - OST-HER2 has received various designations from the US FDA, including Rare Pediatric Disease Designation and Fast-Track designation, indicating its potential significance in treating osteosarcoma [5][7] Group 3: Product Development and Innovation - OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), utilizing proprietary technology for enhanced delivery of therapeutic payloads [8]