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OS Therapies Announces Statistically Significant Positive Interim 2-Year Overall Survival Data from Phase 2b Clinical Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma
66.6% of OST-HER2 treated patients achieved 2-year overall survival compared with 40% in the historical control group (p = 0.0046)FDA issues Biologics Licensing Application (BLA) number for OST-HER2 in preparation for anticipated BLA filing for the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma following August 27, 2025 End of Phase 2 MeetingCompany responds to FDA correspondences seeking to align approval metrics for Regenerative Medicine Advanced Therapy (R
About this update from Os Therapies Incorporated
[{"type":"list","items":[{"val":[{"type":"text","content":"66.6% of OST-HER2 treated patients achieved 2-year overall survival compared with 40% in the historical control group (p = 0.0046)","length":130,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"FDA issues Biologics Licensing Application (BLA) number for OST-HER2 in preparation for anticipated BLA filing for the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma following August 27, 2025 End of Phase 2 Meeting","length":251,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Company responds to FDA correspondences seeking to align approval metrics for Regenerative Medicine Advanced Therapy (RMAT) designation, Breakthrough Therapy designation (BTD) and Biologics Licensing Application via Accelerated Approval Program","length":244,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Company's NYSE American listing included in the Russell Microcap, Russell Microcap Value and Russell Microcap Growth indexes","length":128,"tagName":"p","attribs":{}}]}],"tagName":"ul","bulletedList":true,"length":753,"olType":false},{"type":"text","content":"New York, New York--(Newsfile Corp. - August 7, 2025) - OS Therapies (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced statistically significant positive updated interim 2-year overall survival data from the Company's Phase 2b trial of off-the-shelf immunotherapy candidate OST-HER2 in the prevention of delay of recurrent, fully resected, pulmonary metastatic osteosarcoma. 66.6% (18 out of 27) of OST-HER2 treated patients achieved 2-year overall survival compared with 40% of historical control1 (p = 0.0046).","length":656,"tagName":"p"},{"type":"text","content":"Additionally, the US Food & Drug Administration ("FDA") issued a Biologics Licensing Application ("BLA") number for OST-HER2 to receive a BLA submission following the Company's pending August 27, 2025 End of Phase 2 Meeting. The Company has responded to FDA correspondences seeking to align approval metrics for Regenerative Medicine Advanced Therapy (RMAT) designation, Breakthrough Therapy designation (BTD) and BLA via the Accelerated Approval Program.","length":483,"t...