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OS Therapies Announces Successful pre-Marketing Authorisation Application Meeting with UK MHRA Regarding the Phase 2b Clinical Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma
Alignment achieved on all key points surrounding non-clinical, CMC and post-market authorization confirmatory study designBiomarker data advanced as key pre-specified surrogate clinical efficacy endpoint, with pending analysis awaiting alignment with US FDA on biomarker statistical analysis plan to be discussed at upcoming December 11, 2025 FDA Type C MeetingCompany reiterates end of January 2026 timeline for MAA submissionNew York, New York--(Newsfile Corp. - December 9, 2025) - OS Therapies...
About this update from Os Therapies Incorporated
[{"type":"list","items":[{"val":[{"type":"text","content":"Alignment achieved on all key points surrounding non-clinical, CMC and post-market authorization confirmatory study design","length":122,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Biomarker data advanced as key pre-specified surrogate clinical efficacy endpoint, with pending analysis awaiting alignment with US FDA on biomarker statistical analysis plan to be discussed at upcoming December 11, 2025 FDA Type C Meeting","length":239,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Company reiterates end of January 2026 timeline for MAA submission","length":66,"tagName":"p","attribs":{}}]}],"tagName":"ul","bulletedList":true,"length":427,"olType":false},{"type":"text","content":"New York, New York--(Newsfile Corp. - December 9, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced that it held a successful pre-Marketing Authorisation Application (MAA) with the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) regarding the Phase 2b human clinical trial of OST-HER2 in the prevention or delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma (the 'Metastatic Osteosarcoma Program'). The Company achieved full alignment with its pre-meeting objectives related to non-clinical, CMC (chemistry, manufacturing, and controls) and post-market authorization confirmatory study design.","length":778,"tagName":"p"},{"type":"text","content":"Additionally, the Company advanced the correlation of upregulated immune response biomarkers shown to be activated in OST-HER2 treated canine patients who achieved long term survival with 2-year overall survival data from the OST-HER2 Phase 2b human clinical trial as a surrogate clinical efficacy endpoint to further support the approval of a conditional MAA in the United Kingdom. The Company is awaiting feedback from its upcoming December 11, 2025 meeting with United States Food & Drug Administration (FDA) before initiating the proposed biomarker data analysis to ensure that the analysis is pre-specified, thereby making the resulting data suitable to support a Biologics Licensing Application (BLA) under the Accelerated Approval Program ('Accelerated Approval') i...