OS Therapies, Inc. (NYSE: OSTX) shares began Tuesday sharply lower. The Rockville, Md.-based company, claiming to be the world leader in gene-edited, Listeria-based cancer immunotherapies, today provided regulatory update on the Company's interactions with the U.S. Food and Drug Administration (FDA) in its pursuit of a Biologics License Application (BLA) under the Accelerated Approval Program (Accelerated Approval) for OST-HER2 in the prevention or delay of recurrence in fully resected, pulmonary metastatic osteosarcoma (the "Metastatic Osteosarcoma Program").
OS Therapies has requested a Type B Meeting to review the Company's 2.5-year overall survival data and to confirm alignment that three-year overall survival data is an approvable clinical efficacy endpoint.
The Company recently aligned with the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency on three-year overall survival as the proposed approvable clinical endpoint to support Conditional Marketing Authorizations.
The Company has also submitted its pharmacodynamic response biomarker data to the FDA's Biomarkers, Endpoints, and other Tools (BEST) program for evaluation as a surrogate clinical efficacy data. FDA and EMA have begun joint coordination on the OST-HER2 regulatory dossier to evaluate early market access.
OS Therapies says it intends to review with FDA the potential inclusion of concurrent natural history control database OST-400, "Recurrent Osteosarcoma after Resection in Children and Young Adults: A Retrospective Longitudinal Study," as an added synthetic control comparator arm at the meeting.
OSTX shares lost 33 cents, or 14.7%, to $1.91.
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