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Investing.com -- OS Therapies Inc (NYSE-A:OSTX) stock jumped 12.4% following positive feedback from the FDA regarding its OST-HER2 treatment for osteosarcoma.
The clinical-stage biopharmaceutical company announced it received favorable written feedback from a mid-June FDA Type D Meeting about endpoints required to support an Accelerated Approval Program marketing application for its Phase 2b trial. The trial focuses on OST-HER2 in preventing or delaying recurrence in fully resected, pediatric lung metastatic osteosarcoma.
Following this feedback, OS Therapies has submitted End of Phase 2 Meeting and Breakthrough Therapy Designation requests to the FDA. The End of Phase 2 Meeting is expected in the third quarter of 2025.
Dr. Robert Petit, Chief Medical (TASE:BLWV) & Scientific Officer of OS Therapies, noted that the FDA provided input on using external control comparators in settings where placebo-controlled randomization trials aren’t feasible, particularly for rare pediatric diseases. The agency also suggested statistical methods for comparing OST-HER2 treatment with external control arms to support a Biologics Licensing Application.
OST-HER2 has received Rare Pediatric Disease Designation for osteosarcoma from the FDA. If it receives a conditional BLA via Accelerated Review before September 30, 2026, it will become eligible for a Priority Review Voucher that the company plans to sell immediately. The most recent such voucher sold for $160 million in June 2025.
The company estimates the market opportunity for OST-HER2 in preventing lung metastases exceeds $500 million, within an overall osteosarcoma treatment market valued at $1.2 billion in 2022 according to Data Bridge Market Research.
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