OS Therapies Inc

OSTX

Market cap $72.9M

CDER meeting expected to take place in the summer of 2026 in parallel with CBER's Type B Statistical Methods Meeting New York, New York and Rockville, Maryland--(Newsfile Corp. - July 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 it has accepted a new Meeting Request from the U.S. Food and Drug Administration (FDA)'s Center for Drug Evaluation and Research (CDER) to review the Company's pharmacodynamic response biomarker data (the "OST-HER2 Biomarker Data") – patent pending. CDER's Biomarkers, EndpointS, and other Tools (BEST) resources is part of its Biomarker Qualification Program (BQP).

Upcoming Type B Statistical Methods Meeting expected to set stage for FDA to align with EMA and MHRA on use of Fall 2026 3-year overall survival data combined with biomarkers to support early market access New York, New York and Rockville, Maryland--(Newsfile Corp. - July 6, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, Listeria-based cancer immunotherapies, today provides a third quarter 2026 corporate outlook. The outlook focuses on upcoming clinical and regulatory milestones for the Company's lead program OST-HER2 in the prevention or delay of recurrence in fully resected, pulmonary metastatic osteosarcoma (the "Metastatic Osteosarcoma Program"), advancements with the Company's animal health-focused subsidiary OS Animal Health, Inc. (OSAH) and the Company's financial position as key regulatory and corporate milestones come into focus.

Company secures $10 million line of credit supported by OS Therapies UK tax credits New York, New York and Rockville, Maryland--(Newsfile Corp. - July 2, 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 has appointed Dr. Craig Eagle to the Company's Board of Directors. Dr. Eagle currently serves as the Company's Chief Medical Advisor.

Type B Meeting requested to follow up on September 2025 End of Phase 2 FDA Meeting guidance on statistical methods to be used for BLA Submission Seeking to align FDA with MHRA & EMA on 3-year overall survival as approval endpoint Biomarker data submitted to FDA BEST program as surrogate clinical efficacy data Synthetic historical control arm OST-400 recruitment potentially adds comparator for BLA submission under the Accelerated Approval Review of Rolling Review, RMAT & Breakthrough Therapy designation requests sought New York, New York and Rockville, Maryland--(Newsfile Corp. - June 30, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), 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 3-year overall survival data is an approvable clinical efficacy endpoint.

20% of OST-HER2 treated dogs survived 2-year vs. 1% in control group (p = 0.00995) Over 15,000 dogs per year diagnosed with osteosarcoma Company expects to submit U.S. Department of Agriculture meeting request to gain alignment on regulatory path towards conditional approval in the third quarter of 2026 OS Therapies reiterates plan to distribute OS Animal Health shares to shareholders OS Animal Health plans crowdfunding to expand shareholder base to meet U.S. national exchange initial listing standards, with indications of interest now being received Rockville, Maryland--(Newsfile Corp. - June 26, 2026) - OS Animal Health, Inc. ("OS Animal Health" or "the Company"), the wholly-owned animal health subsidiary of OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies"), the world leader in gene-edited, Listeria-based cancer immunotherapies, today announced the peer-reviewed publication of data from the Phase 2 clinical trial of OST-HER2, together with palliative radiation therapy ("RT"), aimed at preventing amputation in frontline canine osteosarcoma.

Confirmatory Phase 3 trial to commence prior to BLA grant under Accelerated Approval Program in the U.S. and Conditional MAA in the U.K., Europe and Australia Patent pending pharmacodynamic response biomarker accepted as surrogate clinical efficacy endpoint TGA and MHRA agree to allow utilization of remaining Phase 2b drug product for initiation of confirmatory Phase 3 FDA and EMA fully align with Company on Chemistry, Manufacturing and Controls (CMC) Market access process initiated with UK NICE and EU JCA New York, New York and Rockville, Maryland--(Newsfile Corp. - June 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 it achieved alignment on the design of its pending Phase 3 study of OST-HER2 in the prevention or delay of recurrence in fully resected, pulmonary metastatic osteosarcoma with the U.S. Food & Drug Administration (FDA) and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA). A confirmatory Phase 3 study is required to have commenced prior to the grant of a Biologics License Application (BLA) under the Accelerated Approval Program in the U.S. and Conditional Marketing Authorisation Applications (CMAAs) in the U.K., Europe and Australia.

OS Therapies Incorporated (NYSE:OSTX) shares are up during Tuesday's premarket session as the company recently announced that its Phase 2b trial of OST-HER2 achieved statistically significant overall survival results at the 2.5-year mark.

75% 2.5-year overall survival for OST-HER2 vs. 47% pooled historical control (p = 0.003), with no new patient deaths reported since the 2-year overall survival data (75% vs.

The Company confirms that it will release 2.5 year overall survival data from Phase 2b clinical trial OST-HER2 in the prevention or delay of recurrence in fully-resected pulmonary metastatic osteosarcoma during the 2026 American Society of Clinical Oncologists (ASCO) Annual Meeting being held from May 28, 2026 to June 2, 2026. New York, New York and Rockville, Maryland--(Newsfile Corp. - May 29, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, listeria-based cancer immunotherapies, today announced the publication of four articles related to OST-HER2 and/or Osteosarcoma in Drug Discovery World.

ASCO 2026: 2.5-Year Overall Survival Data Jefferies Healthcare Conference: Partnering & Investor meetings BIO International Convention: Panel Participation MIB Agents Factor Osteosarcoma Conference: Data Presentation New York, New York and Rockville, Maryland--(Newsfile Corp. - May 26, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, listeria-based cancer immunotherapies, announced that it will attend upcoming medical, financial and scientific conferences: American Society of Clinical Oncologists 2026 Where: Chicago, ILWhen: May 29, 2026 to June 2, 2026What: 2.5-year overall survival data announcement Jefferies Global Healthcare Conference 2026 Where: New York, NYWhen: June 2, 2026 to June 4, 2026What: Partnering meetings and select investor meetings BIO International Convention 2026 Where: San Diego, CAWhen: June 22, 2026 to June 25, 2026What: Partnering meetings and panel participation - "ADCs: How can we make bringing ADCs to market a faster, simpler, and more collaborative process?" MIB Agents: Factor Osteosarcoma Conference 2026 Where: Columbus, OHWhen: June 25, 2026 to June 27, 2026What: Data Presentation 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.