
OS Therapies Outlines FirstâHalf 2026 Corporate Outlook and Key Milestones
âĒBy ADMIN
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OS Therapies Inc. (NYSE American: OSTX), a clinicalâstage biotechnology company specializing in cancer immunotherapies, today shared its corporate outlook for the first half of 2026, highlighting a series of anticipated regulatory submissions and clinical progress. The company is finalizing preparations to submit a Biologics License Application (BLA) for its lead candidate, OSTâHER2, to the U.S. Food and Drug Administration (FDA) under the Accelerated Approval Program by the end of January 2026. It also plans conditional Marketing Authorisation Application (MAA) filings in the U.K. and European Union by the end of February and March 2026, respectively.
OS Therapies expects to release Phase 2b biomarker data from its metastatic osteosarcoma program during the week of the J.P. Morgan Healthcare Conference in early January. The company anticipates multiple regulatory meetings in H1 2026 with authorities in the U.S., U.K., and Europe, potentially leading to OSTâHER2 approvals in the U.K. in Q2, the U.S. in Q3, and Europe by Q4 2026.
Additionally, OS Therapies plans to advance other oncology programs, including OSTâ504 and OSTâ503, and expects to file for a goâpublic transaction for its OS Animal Health subsidiary with the U.S. Securities and Exchange Commission in early January 2026.
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