OS Therapies News Releases

OS Therapies Schedules OST-HER2 Pharmacodynamic Response Biomarker Conference Call on April 30, 2026 at 8:30am ET

Mon, 27 Apr 2026 16:01:00 -0400

Regulatory feedback from April 2026 EMA and Australian TGA meetingsRemaining Q2-2026 regulatory meetings include two U.S. FDA meetings and one U.K. MHRA meeting, in addition to follow-up meetings with EMA and Australian TGANew York, New York--(Newsfile Corp. - April 27, 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 it will be hosting a conference call on...

OS Therapies Files New Patent Application Covering Biomarkers of the Immune Response to Listeria Monocytogenes

Thu, 16 Apr 2026 07:20:00 -0400

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...

OS Therapies Appoints Biotech Industry Luminary Robert "Bob" S. Langer, PhD as Strategic Advisor

Mon, 13 Apr 2026 06:00:00 -0400

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...

OS Therapies Appoints Craig Eagle, MD as Strategic Advisor

Wed, 08 Apr 2026 11:38:00 -0400

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...

OS Therapies Completes $5.25M Registered Direct Offering Primarily with Pre-Existing High-Net-Worth Investors

Thu, 02 Apr 2026 17:15:00 -0400

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...

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

Tue, 31 Mar 2026 07:40:00 -0400

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...

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

Fri, 27 Mar 2026 06:00:00 -0400

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...

OS Therapies Granted EMA's Advanced Therapy Medicinal Product (ATMP) Designation for OST-HER2 in the Treatment of Pulmonary Recurrence in Resected Osteosarcoma

Wed, 25 Mar 2026 06:00:00 -0400

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...

OS Therapies Announces FDA OST-HER2 Type D Meeting Elevated to Type B Pre-BLA Meeting

Mon, 09 Mar 2026 07:40:00 -0400

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)...

OS Therapies Provides Global Regulatory Update for OST-HER2 in Recurrent, Fully Resected, Pulmonary Metstatic Osteosarcoma

Tue, 17 Feb 2026 06:00:00 -0500

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...