Tuesday, 02 January 2024 12:17 GMT

Investornewsbreaks OS Therapies Inc. (NYSE American: OSTX) Heads To Moody Capital Conference Amid Major OST-HER2 Regulatory Push


(MENAFN- Investor Brand Network) OS Therapies (NYSE American: OSTX) announced its upcoming participation in the Moody Capital Solutions 2026 Disruptive Growth & Life Sciences Conference taking place Sept. 9-10 in New York City, where OS Animal Health will participate and the company is expected to engage with investors and strategic partners. The conference comes as OS Therapies enters a potentially significant regulatory period for OST-HER2, its investigational therapy for fully resected pulmonary metastatic osteosarcoma. The company expects interim three-year overall survival data and key FDA and U.K. regulatory meetings in September, followed by potential RMAT and Rolling Review decisions, with final three-year data, a U.S. Pre-BLA meeting, and regulatory submissions in the U.S., U.K. and Europe targeted for Q4 2026. OS Animal Health is also seeking USDA alignment on reinstating conditional approval for OST-HER2 in canine osteosarcoma.

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About OS Therapies

OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for osteosarcoma (“OS”) and other solid tumors. The company is the world leader in gene-edited, listeria-based cancer immunotherapies. OST-HER2, the company's lead asset, is an immunotherapy leveraging the immune-stimulatory effects of listeria bacteria to initiate a strong immune response targeting the HER2 protein. OST-HER2 is designed to target two mutated extracellular epitopes and one mutated intracellular epitope of the HER2 oncogene, requiring only one of these three epitopes to be present in a tumor (or micro-metastasis) to trigger the desired immune response. OST-HER2 has received Orphan Drug Designation (“ODD”), Fast Track Designation (“FTD”) and Rare Pediatric Disease Designation (“RPDD”) from the U.S. Food & Drug Administration and has received ODD, FTD and Advanced Therapy Medicinal Products (“ATMP”) from the European Medicines Agency.

For more information about the company, please visit .

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