Core Insights - OS Therapies has received a waiver from the U.S. FDA for the application fee related to BLA 125867 for its lead product OST-HER2, which is a listeria-based cancer immunotherapy [1][6] - The European Medicines Agency (EMA) has granted eligibility for Union Marketing Authorisation for OST-HER2 in the prevention or delay of recurrent, fully-resected pulmonary metastatic osteosarcoma, with a request for an accelerated Marketing Authorisation Application by February 28, 2026 [2] - The company is preparing for pre-Marketing Authorisation Application meetings with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and the U.S. FDA to discuss final commercial considerations and study designs [3][6] Company Overview - OS Therapies is a clinical-stage oncology company focused on developing treatments for osteosarcoma and other solid tumors, leading in listeria-based cancer immunotherapies [4] - OST-HER2 has received multiple designations from regulatory bodies, including Rare Pediatric Disease Designation and Fast-Track and Orphan Drug designations from the U.S. FDA and EMA [4] - The company reported positive results from its Phase 2b clinical trial of OST-HER2, showing statistically significant benefits in the 12-month event-free survival primary endpoint [4] Future Developments - The company anticipates submitting a Biologics Licensing Application (BLA) for OST-HER2 in early 2026, which could lead to eligibility for a Priority Review Voucher [4] - OS Therapies is also advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), utilizing proprietary technology for enhanced delivery [5][7]