OS Therapies (OSTX) announced that it received written feedback from the FDA Type D Meeting that occurred in mid-June 2025 regarding endpoints required to support an accelerated approval program marketing application for its Phase 2b trial of OST-HER2 in the prevention or delay of recurrence in fully resected, pediatric lung metastatic osteosarcoma. The company reiterates that additional data from its Phase 2b trial will be presented at the major osteosarcoma conference MIB Factor in Salt Lake City on Saturday June 28. Concurrent with this announcement, the company announced that it has submitted End of Phase 2 Meeting and Breakthrough Therapy Designation requests to FDA based on the positive Type D Meeting feedback. The End of Phase 2 Meeting is expected to occur in the third quarter of 2025. This is in alignment with the company’s overall regulatory strategy and timelines.
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