OS Therapies Inc. Awaits FDA Feedback for RMAT Designation and Plans Rolling BLA Submission for OST-HER2 in Pediatric Osteosarcoma Prevention

Reuters
06/06
<a href="https://laohu8.com/S/OSTX">OS Therapies</a> Inc. Awaits FDA Feedback for RMAT Designation and Plans Rolling BLA Submission for OST-HER2 in Pediatric Osteosarcoma Prevention

NEW YORK--(BUSINESS WIRE)-- OS Therapies Inc. (NYSE-A: OSTX), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, has announced its submission for a Regenerative Medicine Advanced Therapy (RMAT) Designation to the U.S. FDA for OST-HER2. This designation is sought for the prevention of metastases in recurrent, fully-resected, lung metastatic pediatric osteosarcoma. If granted, OST-HER2 would become the first listeria investigational medicinal product to receive the RMAT designation. This designation would facilitate an accelerated Biologics License Application $(BLA.AU)$ review and enhance interactions with the FDA to streamline market access. The company anticipates feedback from a Type D meeting with the FDA by mid-June 2025, which will inform their End of Phase 2 meeting request and potential rolling BLA submission in the third quarter of 2025.

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: 20250602523393) on June 06, 2025, and is solely responsible for the information contained therein.

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