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Two Blokes Jul 10 -
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End of Phase 2 Meeting with FDA scheduled for August 27, 2025 to review OST-HER2 recurrent, pulmonary metastatic osteosarcoma program Scientific Advice Meetings confirmed with global regulators in major markets - including the United Kingdom and European Union All patients enrolled in its Phase 1 clinical study of OST-504 in second line prostate cancer have completed treatment, with data expected to be announced later in 2025 New York, New York--(Newsfile Corp. - July 10, 2025) - OS Therapies (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today provided a clinical and global regulatory update on its currently active clinical-stage oncology programs. The Company announced that the End of Phase 2 Meeting granted by the US Food & Drug Administration ("FDA") to review the clinical data from its OST-HER2 recurrent, pulmonary metastatic osteosarcoma program is scheduled for August 27, 2025, during which the Company expects to seek alignment with FDA to begin a rolling review Biologics Licensing Application ("BLA") submission to FDA under its Accelerated Approval Program ("Accelerated Approval").
