OS Therapies Inc. is a well-known biotechnology company performing on the healthcare field with clinical level researches, be it its expertise evaluation or any other effective product. The company focuses on sharpening the edges of improvement and precision in creative and effective immunotherapies for breast cancer, numerous solid tumors and Osteosarcoma. The confidence of OS doubles with its star product, OST-HER2.
OS Therapies Inc. has applied for a Biologics Licence Application (BLA) for its OST-HER2 approval to the U.S. FDA. The need for OST-HER2 approval is important to postpone or avoid resecting recurrent pulmonary metastatic osteosarcoma. It’s also popularly known as Human Metastatic Osteosarcoma. OS enveloped the CMC (Chemistry, Manufacturing and Controls) Non-clinical modules, attached with the kind request of announcing review.
This OST-HER2 submission decision was fuelled during the December 2025 Type C Meeting, where OS Therapies was invited. At the same meeting company asked for a Type D Meeting. The request for a Type D Meeting was urged to review its robust competitive oncology OST-HER2 biomarker data.
The data is followed by the OS’s Phase 2b human clinical trial in Human Metastatic Osteosarcoma, and in a relevant trial of OST-HER2 in mechanical osteosarcoma canines. This is how the company requested the FDA to review its OST-HER2 Comparative Oncology Data.
Keeping up with what OS once asked, it will definitely submit a clinically proven BLA module soon, which will be rooted in OST-HER2 Comparative Oncology Data. The company expects to envelope the submission in March 2026 in such a potential way that it gets an FDA green signal by September 2026.
OS Therapies also confirmed that it has trimmed and improved its Regenerative Medicine Advanced Therapy (RMAT) designation presentation to sound convincing and trustworthy to the FDA with its latest biomarker data. The force of the RMAT designation will be quick with the review as compared to the standard timelines, eventually reducing the distance between the solution and the patient.
If the data gets approval, then this would be the next news lined up for OS Therapies. The latest OST-HER2 result will soon be out, hopefully with a big ‘YES’. MPH, CEO and Chairman of OS Therapies, Paul Romness, said, “We are thrilled after learning of the FDA’s attention to the OST-HER2 Comparative Oncology Data review.”
Mansi Kadam is a market research writer with over 3 years of experience analyzing trends in the healthcare industry. At Towards Healthcare, she covers innovations in medical sector, sustainability initiatives, and the evolving regulatory landscape.
