- OS Therapies (OSTX, Financial) submits RMAT designation request for OST-HER2 to the U.S. FDA.
- OST-HER2 aims to prevent metastases in recurrent, resected, lung metastatic pediatric osteosarcoma.
- If awarded, OST-HER2 could reduce BLA application review time, increasing market access opportunities.
OS Therapies Inc. (OSTX), a clinical-stage biotechnology company, has submitted a request for Regenerative Medicine Advanced Therapy (RMAT) designation to the U.S. FDA for their investigational drug OST-HER2. The drug is designed to prevent metastases in recurrent, fully-resected, lung metastatic pediatric osteosarcoma. The RMAT designation aims to facilitate the development and expedite the review process for regenerative medicine therapies addressing serious or life-threatening conditions.
OST-HER2 has previously secured Rare Pediatric Disease Designation, Orphan Drug Designation, and Fast Track Designation from the U.S. FDA. The potential RMAT designation would enable OS Therapies to benefit from an accelerated Biologics License Application (BLA) review process, enhancing their interactions with regulatory authorities to facilitate market entry.
Furthermore, OS Therapies plans to seek a Priority Review Voucher (PRV) if OST-HER2 receives conditional BLA approval before September 30, 2026. The company plans to sell this voucher, with the most recent similar transaction valued at $155 million in May 2025.
The company is awaiting feedback from the FDA by mid-June 2025 regarding their statistical analysis plan and aims to initiate a rolling BLA submission in Q3 2025. Additionally, OS Therapies is pursuing regulatory approvals in Europe and the United Kingdom and expanding its late-stage clinical development for other pipeline candidates, underscoring its strategic growth pursuits.
