OS Therapies Inc. Advances Towards FDA Accelerated Approval with Positive Phase 2b Trial Results for OST-HER2 in Osteosarcoma Treatment
Reuters
Jun 30, 2025
<a href="https://laohu8.com/S/OSTX">OS Therapies</a> Inc. Advances Towards FDA Accelerated Approval with Positive Phase 2b Trial Results for OST-HER2 in Osteosarcoma Treatment
OS Therapies Inc., a clinical-stage biopharmaceutical company, announced an important regulatory update regarding their immunotherapy candidate OST-HER2. The company has submitted preliminary external control data and comprehensive plans to the US Food & Drug Administration (FDA) as part of their efforts to secure marketing authorization under the FDA's Accelerated Approval Program. This submission is in line with the prevailing guidance to industry, including ICH E10 and other FDA guidelines. The regulatory update follows recent positive clinical trial data showing statistically significant 1-year event-free survival for their Phase 2b trial in lung metastatic osteosarcoma. OS Therapies has also responded to follow-up questions from the FDA Type D Meeting, positioning them for an End of Phase 2 meeting, further advancing their regulatory review process.
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: 20250630174522) on June 30, 2025, and is solely responsible for the information contained therein.
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