OS Therapies Inc. Granted End of Phase 2 Meeting by FDA for OST-HER2 Program in Osteosarcoma Prevention

Reuters
07/03
<a href="https://laohu8.com/S/OSTX">OS Therapies</a> Inc. Granted End of Phase 2 Meeting by FDA for OST-HER2 Program in Osteosarcoma Prevention

OS Therapies Inc., a clinical-stage immunotherapy and Antibody Drug Conjugate biopharmaceutical company, has been granted an End of Phase 2 Meeting by the United States Food & Drug Administration (FDA) for its OST-HER2 program. This program focuses on the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma. The meeting, anticipated for the third quarter of 2025, marks a significant milestone in the drug's development process. OS Therapies plans to seek FDA alignment to initiate a Rolling Review process for the Biologics Licensing Application $(BLA.AU)$ submission of OST-HER2. This approach allows for submission of completed sections of the BLA for FDA review, potentially expediting the approval timeline. The OST-HER2 program has already received FDA Orphan Disease Designation, Fast Track, and Rare Pediatric Disease Designation. If the company secures Accelerated Approval by September 30, 2026, it may receive a Priority Review Voucher, which it intends to sell.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. OS Therapies Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20250703693366) on July 03, 2025, and is solely responsible for the information contained therein.

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