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OS Therapies Granted FDA End-of-Phase 2 Meeting for Potential Osteosarcoma Immunotherapy
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OS Therapies Granted FDA End-of-Phase 2 Meeting for Potential Osteosarcoma Immunotherapy
Jul 3, 2025 5:54 AM

08:31 AM EDT, 07/03/2025 (MT Newswires) -- OS Therapies ( OSTX ) said Thursday the US Food and Drug Administration has granted an end-of-phase 2 meeting to review OST-HER2 immunotherapy for the prevention or delay of recurrent, fully resected pulmonary metastatic osteosarcoma.

The company said it expects the meeting to take place in Q3 as it seeks FDA alignment for a rolling review process for its upcoming biologics licensing application for OST-HER2.

The investigational immunotherapy for osteosarcoma has received orphan disease, fast track, and rare pediatric disease designations from the FDA, said the company.

Shares of OS Therapies ( OSTX ) rose more than 8% in recent Thursday premarket activity.

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