OS Therapies Positioned to Produce OST-HER2 to Support Expected BLA Filing

February 14, 2025

DENVER, Colo., Feb 14, 2025 (247marketnews.com)- OS Therapies (NYSE:OSTX) reported making significant progress on its OST-HER2 production program.

OS Therapies entered into agreements for the commercial manufacture of OST-HER2, marking an important step toward preparing the treatment for larger-scale production and potential commercialization.

The company is organizing additional data from the Phase 2b trial of OST-HER2, which is focused on preventing the recurrence of lung metastatic osteosarcoma. This data will be used in preparation for a Type B or Type C meeting with the U.S. Food & Drug Administration (FDA). These meetings are aimed at discussing the next steps in the regulatory process for the drug.

After the meeting with the FDA, OS Therapies anticipates submitting a Biologics Licensing Application (BLA) to the FDA. The company is seeking accelerated or conditional approval consideration for OST-HER2, which could potentially speed up the approval process based on promising early-stage data or unmet medical needs.

OST-HER2 is being developed as a potential treatment to prevent recurrence in patients with lung metastatic osteosarcoma, a rare and aggressive form of bone cancer. The progress towards FDA meetings and the intent to submit a BLA is a significant step toward making OST-HER2 available to patients.

FDA Accelerated Approval could potentially allow OST-HER2 to enter the market more quickly, benefiting patients with limited treatment options in this difficult-to-treat cancer space.

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