OS Therapies Inc. Announces Upcoming BLA Submission for OST-HER2 Following Positive FDA Phase 2 Meeting for Metastatic Osteosarcoma Program
Reuters
Sep 02
<a href="https://laohu8.com/S/OSTX">OS Therapies</a> Inc. Announces Upcoming BLA Submission for OST-HER2 Following Positive FDA Phase 2 Meeting for Metastatic Osteosarcoma Program
OS Therapies Inc. has announced that it is on track to begin the submission of a rolling Biologics Licensing Application (BLA) request for its OST-HER2 program to the U.S. Food & Drug Administration in September 2025. This submission pertains to the company's Metastatic Osteosarcoma Program, specifically targeting recurrent, fully resected, pulmonary metastatic osteosarcoma. The announcement follows a productive End of Phase 2 Meeting with the FDA. Luis Rojas, PhD, CEO of InCSD, will present on the development of rare disease therapies, including OST-HER2, at the Rare Trials Summit in Boston on September 9, 2025. The presentation will focus on strategies for efficient clinical development and the potential for OST-HER2 to receive Accelerated or full approval based on Phase 2b clinical trial data. Further discussions on the program's progress and outcome measures are expected at a workshop on October 10, 2025, co-hosted by FDA and OSI.
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