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<title>Os Therapies Incorporated — News on 6ix</title>
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<title>Os Therapies Incorporated</title>
<link>https://6ix.com/company/os-therapies-incorporated</link>
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<title>OS Therapies Files New Patent Application Covering Biomarkers of the Immune Response to Listeria Monocytogenes</title>
<link>https://6ix.com/company/os-therapies-incorporated/news/os-therapies-files-new-patent-application-covering-biomarkers-of-the-immune-response-to-listeria-monocytogenes</link>
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<pubDate>Thu, 16 Apr 2026 11:20:00 GMT</pubDate>
<description>New patent application covers treatment-emergent immune signature related to 'turning cold tumors hot' and the activation of targeted cytotoxic cellular immune responses Company to host conference call later in April 2026 to review new biomarker signatureBiomarker signature meets pharmacodynamic/response criteria established by FDA's Biomarkers, EndpointS and other Tools (BEST) program for use as a surrogate clinical endpoint of 1-year event free survival and 2-year overall survival in...</description>
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<title>OS Therapies Appoints Biotech Industry Luminary Robert "Bob" S. Langer, PhD as Strategic Advisor</title>
<link>https://6ix.com/company/os-therapies-incorporated/news/os-therapies-appoints-biotech-industry-luminary-robert-bob-s-langer-phd-as-strategic-advisor</link>
<guid isPermaLink="true">https://6ix.com/company/os-therapies-incorporated/news/os-therapies-appoints-biotech-industry-luminary-robert-bob-s-langer-phd-as-strategic-advisor</guid>
<pubDate>Mon, 13 Apr 2026 10:00:00 GMT</pubDate>
<description>Co-founder of more than 40 biotechnology companies, including 16 IPOs and 19 successful acquisitions Scientific and medical titan focused on driving innovation for human healthWill assist with listeria oncology pipeline prioritization, combinations with other oncology-focused biotechnologies and tADC candidate selection for further developmentNew York, New York--(Newsfile Corp. - April 13, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in...</description>
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<title>OS Therapies Appoints Craig Eagle, MD as Strategic Advisor</title>
<link>https://6ix.com/company/os-therapies-incorporated/news/os-therapies-appoints-craig-eagle-md-as-strategic-advisor</link>
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<pubDate>Wed, 08 Apr 2026 15:38:00 GMT</pubDate>
<description>Senior leadership roles at Guardant Health, Genentech and PfizerRegulatory, clinical and commercial expertise in therapeutics and biomarkersWill assist with osteosarcoma regulatory advice and oncology pipeline prioritizationNew York, New York--(Newsfile Corp. - April 8, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, listeria-based cancer immunotherapies, today announced that Craig Eagle, MD, was appointed to the Company's...</description>
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<title>OS Therapies Completes $5.25M Registered Direct Offering Primarily with Pre-Existing High-Net-Worth Investors</title>
<link>https://6ix.com/company/os-therapies-incorporated/news/os-therapies-completes-dollar525m-registered-direct-offering-primarily-with-pre-existing-high-net-worth-investors</link>
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<pubDate>Thu, 02 Apr 2026 21:15:00 GMT</pubDate>
<description>Company expects approximately $2 million in non-dilutive VAT refunds from wholly owned U.K. subsidiary in 2Q-26Company expects to receive approximately $2 million in non-dilutive R&D tax credits repayable to the company in cash from its U.K. subsidiary in 2H-26Offering net proceeds, together with funds expected to be received via U.K. subsidiary, expected to provide cash runway into 2027Company expects to receive approvals in the U.S., U.K. and Europe for OST-HER2 in the prevention of delay of..</description>
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<title>OS Therapies Completes Submission of Biomarker & Clinical Data for U.S. FDA Pre-BLA Meeting, Reports Full Year 2025 Financial Results and Provides Business Update</title>
<link>https://6ix.com/company/os-therapies-incorporated/news/os-therapies-completes-submission-of-biomarker-and-clinical-data-for-us-fda-pre-bla-meeting-reports-full-year-2025-financial-results-and-provides-business-update</link>
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<pubDate>Tue, 31 Mar 2026 11:40:00 GMT</pubDate>
<description>December 2025 Type C Meeting confirmed immune biomarkers suitability to establish surrogate clinical efficacy that could support BLA under Accelerated Approval PathwayPre-specified clinical outcomes data correlates with Immune biomarker signatureCompany positioned to review completed Phase 2b clinical & biomarker data and confirmatory Phase 3 trial protocol with U.S. FDA, EMA and U.K. MHRA in 2Q/26Company expects to initiate confirmatory Phase 3 trial in Australia in 3Q/26Company anticipates...</description>
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<title>OS Therapies Granted Meetings with U.S. FDA, U.K. MHRA, EMA and Australian Therapeutic Goods Administration to Review Global Confirmatory Phase 3 Trial for OST-HER2 in Metastatic Osteosarcoma</title>
<link>https://6ix.com/company/os-therapies-incorporated/news/os-therapies-granted-meetings-with-us-fda-uk-mhra-ema-and-australian-therapeutic-goods-administration-to-review-global-confirmatory-phase-3-trial-for-ost-her2-in-metastatic-osteosarcoma</link>
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<pubDate>Fri, 27 Mar 2026 10:00:00 GMT</pubDate>
<description>Meetings with all four regulatory agencies scheduled to occur in the second quarter of 2026, with expected Phase 3 commencement in the third quarter of 2026 initially in Australia Commencing the Phase 3 confirmatory study is a pre-requisite to being granted a Biologics License Application (BLA) under the Accelerated Approval Program in the U.S. and Conditional Marketing Authorisations (CMAs) in the U.K. & EuropeNew York, New York--(Newsfile Corp. - March 27, 2026) - OS Therapies, Inc. (NYSE...</description>
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<title>OS Therapies Granted EMA's Advanced Therapy Medicinal Product (ATMP) Designation for OST-HER2 in the Treatment of Pulmonary Recurrence in Resected Osteosarcoma</title>
<link>https://6ix.com/company/os-therapies-incorporated/news/os-therapies-granted-emas-advanced-therapy-medicinal-product-atmp-designation-for-ost-her2-in-the-treatment-of-pulmonary-recurrence-in-resected-osteosarcoma</link>
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<pubDate>Wed, 25 Mar 2026 10:00:00 GMT</pubDate>
<description>ATMP benefits include access to the Conditional Marketing Authorisation accelerated market access pathway in Europe, significantly reduced user fees for small and medium-sized enterprises (SMEs), tailored regulatory assessment via Committee for Advanced Therapies (CAT) and increased pricing power New York, New York--(Newsfile Corp. - March 25, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today...</description>
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<title>OS Therapies Announces FDA OST-HER2 Type D Meeting Elevated to Type B Pre-BLA Meeting</title>
<link>https://6ix.com/company/os-therapies-incorporated/news/os-therapies-announces-fda-ost-her2-type-d-meeting-elevated-to-type-b-pre-bla-meeting</link>
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<pubDate>Mon, 09 Mar 2026 11:40:00 GMT</pubDate>
<description>FDA's elevated meeting status signals transition from biomarker data discussions to Accelerated Approval discussionsOS Therapies on track to complete clinical data submission by the end of Q1 2026New York, New York--(Newsfile Corp. - March 9, 2026) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today provided an update regarding ongoing conversations with the United States Food & Drug Administration (FDA)...</description>
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<title>OS Therapies Provides Global Regulatory Update for OST-HER2 in Recurrent, Fully Resected, Pulmonary Metstatic Osteosarcoma</title>
<link>https://6ix.com/company/os-therapies-incorporated/news/os-therapies-provides-global-regulatory-update-for-ost-her2-in-recurrent-fully-resected-pulmonary-metstatic-osteosarcoma</link>
<guid isPermaLink="true">https://6ix.com/company/os-therapies-incorporated/news/os-therapies-provides-global-regulatory-update-for-ost-her2-in-recurrent-fully-resected-pulmonary-metstatic-osteosarcoma</guid>
<pubDate>Tue, 17 Feb 2026 11:00:00 GMT</pubDate>
<description>Additional forthcoming biomarker data from human trial expected to further characterize immune pathway activation and its relationship to clinical outcomesU.S., U.K. and European osteosarcoma key opinion leaders assembling to review clinical & biomarker trial data, and comment on proposed confirmatory trial designAyala Pharmaceuticals announces dissolution following liquidation of assetsNew York, New York--(Newsfile Corp. - February 17, 2026) - OS Therapies Inc. (NYSE American: OSTX) ("OS...</description>
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<title>OS Therapies Applauds Reauthorization of Pediatric Priority Review Voucher Program to Advance Breakthrough Osteosarcoma Immunotherapies</title>
<link>https://6ix.com/company/os-therapies-incorporated/news/os-therapies-applauds-reauthorization-of-pediatric-priority-review-voucher-program-to-advance-breakthrough-osteosarcoma-immunotherapies</link>
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<pubDate>Wed, 04 Feb 2026 17:45:00 GMT</pubDate>
<description>New York, New York--(Newsfile Corp. - February 4, 2026) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, is honored to celebrate the passage of the Mikaela Naylon Give Kids A Chance Act. Mikaela, like so many other children, courageously battled pediatric cancer - specifically Osteosarcoma. Her legacy through this legislation will accelerate critical opportunities for research and therapeutic access for other.</description>
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<title>OS Therapies Initiates US FDA BLA Filing for OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma</title>
<link>https://6ix.com/company/os-therapies-incorporated/news/os-therapies-initiates-us-fda-bla-filing-for-ost-her2-in-the-prevention-or-delay-of-recurrent-fully-resected-pulmonary-metastatic-osteosarcoma</link>
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<pubDate>Mon, 02 Feb 2026 11:00:00 GMT</pubDate>
<description>Request for FDA Rolling Review submitted to FDA on January 30, 2026Non-Clinical and CMC BLA modules submitted to FDAAt FDA's request, Type D Meeting expected in March 2026 to review Comparative Oncology biomarker data from patients treated in OST-HER2 Phase 2b human clinical trial and OST-HER2 trial in spontaneous osteosarcoma in caninesFinal BLA clinical module expected to be submitted to FDA by end of March 2026 after Type D Meeting Regenerative Medicine Advanced Therapy (RMAT) designation...</description>
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<title>OS Therapies Announces Positive Biomarker Data from Phase 2b Clinical Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma</title>
<link>https://6ix.com/company/os-therapies-incorporated/news/os-therapies-announces-positive-biomarker-data-from-phase-2b-clinical-trial-of-ost-her2-in-the-prevention-or-delay-of-recurrent-fully-resected-pulmonary-metastatic-osteosarcoma</link>
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<pubDate>Thu, 15 Jan 2026 12:00:00 GMT</pubDate>
<description>Activation of immune blood biomarkers from interferon gamma pathway distinguished long term survivors (>=2 years) from short-term survivors (<1year)Pre-specified pathway analysis strategy developed as a result of immune biomarker pathway data generated from 118-patient canine metastatic osteosarcoma study published in February 2025 demonstrates translational power of Comparative Oncology to identify surrogate markers of clinical efficacyNew York, New York--(Newsfile Corp. - January 15, 2026) -..</description>
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<title>OS Therapies Announces Filing Form S-1 of OS Animal Health Subsidiary</title>
<link>https://6ix.com/company/os-therapies-incorporated/news/os-therapies-announces-filing-form-s-1-of-os-animal-health-subsidiary</link>
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<pubDate>Wed, 14 Jan 2026 12:00:00 GMT</pubDate>
<description>OS Animal Health (OSAH), a wholly-owned subsidiary of OS Therapies (OSTX), targeting Initial Public Offering (IPO) on NYSE American or Nasdaq Capital Markets national stock exchange in the first half of 2026 (1H/2026)OSTX shareholders expected to receive one (1) share of OSAH for every ten (10) shares of OSTX owned as of the expected to-be-determined 1H/2026 record dateOSAH to focus primarily on the re-establishment of USDA conditional approval and commercialization of immunotherapy OST-HER2 for</description>
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<title>OS Therapies Enters into Warrant Inducement Agreements</title>
<link>https://6ix.com/company/os-therapies-incorporated/news/os-therapies-enters-into-warrant-inducement-agreements</link>
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<pubDate>Mon, 12 Jan 2026 13:01:00 GMT</pubDate>
<description>$7.53M gross proceeds raised from pre-existing investors, providing capital runway into 2027All nine investors that were offered agreed to participateNet proceeds to fund OST-HER2 regulatory approval submissions, commercial preparation activities and preparations for OS Animal Health proposed spinoff transactionNew York, New York--(Newsfile Corp. - January 12, 2026) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or the "Company"), the world leader in listeria-based cancer...</description>
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<title>OS Therapies Provides First Half 2026 Corporate Outlook</title>
<link>https://6ix.com/company/os-therapies-incorporated/news/os-therapies-provides-first-half-2026-corporate-outlook</link>
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<pubDate>Mon, 05 Jan 2026 12:40:00 GMT</pubDate>
<description>Company finalizing preparations for end of January 2026 U.S. FDA Biologics License Application (BLA) submission for OST-HER2 program in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma (Metastatic Osteosarcoma Program) under Accelerated Approval ProgramBiomarker data from Phase 2b Metastatic Osteosarcoma Program human clinical trial expected to be released during week of J.P. Morgan Healthcare Conference 2026UK and EU Marketing Authorisation Application...</description>
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<title>OS Therapies Announces Successful Type C Meeting with US FDA Regarding Phase 2b Clinical Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma</title>
<link>https://6ix.com/company/os-therapies-incorporated/news/os-therapies-announces-successful-type-c-meeting-with-us-fda-regarding-phase-2b-clinical-trial-of-ost-her2-in-the-prevention-or-delay-of-recurrent-fully-resected-pulmonary-metastatic-osteosarcoma</link>
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<pubDate>Mon, 15 Dec 2025 11:00:00 GMT</pubDate>
<description>FDA confirmed that data from single-arm studies in rare diseases, such as in ultra-rare deadly pediatric cancer osteosarcoma, could support a Biologics Licensing Application (BLA) under Accelerated Approval Program pathway, as stated in FDA guidance documentsFDA proposed confirmatory study design include additional osteosarcoma disease settings such as prevention of recurrence following primary tumor resection, where a randomized controlled study may be feasible and that the confirmatory study..</description>
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<title>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</title>
<link>https://6ix.com/company/os-therapies-incorporated/news/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</link>
<guid isPermaLink="true">https://6ix.com/company/os-therapies-incorporated/news/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</guid>
<pubDate>Tue, 09 Dec 2025 12:40:00 GMT</pubDate>
<description>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...</description>
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<title>OS Therapies Announces FDA PDUFA Waiver & EMA Grants Union Marketing Authorisation Eligibility</title>
<link>https://6ix.com/company/os-therapies-incorporated/news/os-therapies-announces-fda-pdufa-waiver-and-ema-grants-union-marketing-authorisation-eligibility</link>
<guid isPermaLink="true">https://6ix.com/company/os-therapies-incorporated/news/os-therapies-announces-fda-pdufa-waiver-and-ema-grants-union-marketing-authorisation-eligibility</guid>
<pubDate>Fri, 05 Dec 2025 13:01:00 GMT</pubDate>
<description>U.S. FDA grants waiver of application fee for BLA Filing of OST-HER2Scheduled pre-Marketing Authorisation Application meeting with United Kingdom's Medicines and Healthcare products Regulatory Agency on December 8, 2025Scheduled Type C Meeting with United States Food & Drug Administration on December 11, 2025New York, New York--(Newsfile Corp. - December 5, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer...</description>
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<title>OS Therapies Receives Non-Proprietary Name 'daznelimgene lisbac' for OST-HER2 from World Health Organization</title>
<link>https://6ix.com/company/os-therapies-incorporated/news/os-therapies-receives-non-proprietary-name-daznelimgene-lisbac-for-ost-her2-from-world-health-organization</link>
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<pubDate>Tue, 25 Nov 2025 14:21:00 GMT</pubDate>
<description>New York, New York--(Newsfile Corp. - November 25, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced that the International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO) approved 'daznelimgene lisbac' for the non-proprietary name for the Company's HER2 targeted Listeria monocytogenes-based cancer immunotherapy product candidate OST-HER2. OST-HER2 is...</description>
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<title>OS Therapies to Spinoff OS Animal Health into Standalone Public Company</title>
<link>https://6ix.com/company/os-therapies-incorporated/news/os-therapies-to-spinoff-os-animal-health-into-standalone-public-company</link>
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<pubDate>Thu, 20 Nov 2025 12:40:00 GMT</pubDate>
<description>Successful preliminary discussion with NYSE representatives and potential investorsOS Therapies shareholders to receive direct equity participation in new listing'Shelter Me: Cancer Pioneers' film featuring canine and human patients treated with OST-HER2 receives Anthem Award in the 'Documentary or Film under Awareness Categories, Health' categoryCompany congratulates Disney (NYSE: DIS) for winning the 2025 Daytime Emmy 'Outstanding Daytime Special' category and Netflix (NYSE: NFLX) for winning.</description>
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