OS Therapies Initiates Commercial-ready Manufacturing of OST-HER2 to Support Anticipated Biologics Licensing Authorization (BLA) Filing

On February 14, 2025 OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, reported that it has entered into agreements for the commercial manufacture of OST-HER2 (Press release, OS Therapies, FEB 14, 2025, View Source [SID1234650299]). The Company is currently organizing additional data in relation to the recently-completed treatment phase of its Phase 2b trial of OST-HER2 in the prevention of recurrence of lung metastatic osteosarcoma in preparation for a Type B or Type C meeting with the US Food & Drug Administration ("FDA"). Following the FDA meeting, the Company anticipates that it will be submitting a Biologics Licensing Authorization (BLA) application to the FDA for accelerated or conditional approval consideration.

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