NEW YORK--(BUSINESS WIRE)-- OS Therapies Inc. (NYSE-A: OSTX), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, has announced its submission for a Regenerative Medicine Advanced Therapy (RMAT) Designation to the U.S. FDA for OST-HER2. This designation is sought for the prevention of metastases in recurrent, fully-resected, lung metastatic pediatric osteosarcoma. If granted, OST-HER2 would become the first listeria investigational medicinal product to receive the RMAT designation. This designation would facilitate an accelerated Biologics License Application $(BLA.AU)$ review and enhance interactions with the FDA to streamline market access. The company anticipates feedback from a Type D meeting with the FDA by mid-June 2025, which will inform their End of Phase 2 meeting request and potential rolling BLA submission in the third quarter of 2025.
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