OS Therapies Inc. reported its third quarter 2025 financial results and provided a business update for the period ended September 30, 2025. The company highlighted that it remains eligible for a Priority Review Voucher (PRV) based on Pediatric Rare Pediatric Disease Designation (RPDD) for osteosarcoma if OST-HER2 is approved by September 30, 2026. OS Therapies announced that a Type C meeting with the US FDA is scheduled for December 11, 2025, following the August 27, 2025 End of Phase 2 meeting, to address key items regarding the Phase 2b clinical trial of OST-HER2 for the prevention or delay of recurrent, fully-resected pulmonary metastatic osteosarcoma. The company expects to file US Biologics Licensing Application (BLA) and UK MHRA Marketing Authorization Application $(MAA)$ for OST-HER2 in January 2026, leveraging Project Orbis. Additionally, the company recently completed a $7.8 million warrant exercise inducement, providing capital into late 2026 by delaying the launch to 2027. OS Therapies also reported that biomarker data for OST-HER2 are expected to be available for upcoming FDA and MHRA meetings, which will inform post-market confirmatory clinical development and market surveillance commitments. The company is also anticipating data from its OST-504 Phase 1b program in castration resistant prostate cancer and intends to seek FDA Platform Designation for its listeria cancer immunotherapy platform when eligible.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. OS Therapies Inc. published the original content used to generate this news brief via Newsfile (Ref. ID: 274747) on November 17, 2025, and is solely responsible for the information contained therein.
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