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OS Therapies Accepts New FDA Meeting Request to Review Biomarker Data as Part of BEST Program

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.…

Newsfile Corp • Jul 8, 2026
OS Therapies Third Quarter 2026 Corporate Outlook

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…

Newsfile Corp • Jul 6, 2026
OS Therapies Appoints Dr. Craig Eagle to Board of Directors

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…

Newsfile Corp • Jul 2, 2026
OS Therapies Provides U.S. Regulatory Update

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…

Newsfile Corp • Jun 30, 2026
OS Animal Health Announces Peer-Reviewed Publication of Clinical Trial Data for OST-HER2 Plus Palliative Radiation as Frontline Treatment in Canine Osteosarcoma

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…

Newsfile Corp • Jun 26, 2026

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