OS Therapies Submits Request For RMAT Designation For OST-HER2

(RTTNews) - OS Therapies (OSTX) has submitted a request for Regenerative Medicine Advanced Therapy Designation to FDA for OST-HER2 in the prevention of metastases in recurrent, fully-resected, lung metastatic pediatric osteosarcoma. OST-HER2 has already received Rare Pediatric Disease Designation, Orphan Drug Designation and Fast Track Designation for osteosarcoma.

OS Therapies noted that, if OST-HER2 receives a conditional BLA via Accelerated Review prior to September 30, 2026, the company will become eligible to receive a Priority Review Voucher that it intends to immediately sell.

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