OS Therapies seeks FDA alignment on 3-year overall survival endpoint for OST-HER2 accelerated approval bid

OS Therapies Incorporated

OS Therapies Incorporated

OSTX

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  • OS Therapies requested an FDA Type B meeting to support an accelerated-approval filing for OST-HER2 in resected pulmonary metastatic osteosarcoma.
  • Interim overall survival results have already been generated, with a 3-year overall survival readout scheduled for early fall.
  • The company is seeking FDA alignment to use 3-year overall survival as an approvable endpoint, matching positions reached with U.K. and EU regulators.
  • Biomarker data were submitted to the FDA BEST program to support a surrogate efficacy case for earlier market access.
  • A retrospective natural-history study database, OST-400, is being positioned as a synthetic control comparator to strengthen the planned BLA package.


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 Newsfile (Ref. ID: 202606300740NEWSFILECNPR____20260630_303383_1) on June 30, 2026, and is solely responsible for the information contained therein.

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