Curated News
By: NewsRamp Editorial Staff
September 30, 2026
OS Therapies Advances Breakthrough Osteosarcoma Treatment Toward Approval
TLDR
- OS Therapies' OST-HER2 shows 75% 2-year survival advantage over historical controls, positioning it for potential market leadership in osteosarcoma treatment with 2027 revenue launch.
- OS Therapies is preparing harmonized FDA and UK MHRA filings for OST-HER2 based on Phase 2b trial data showing 75% 2-year overall survival in pulmonary metastatic osteosarcoma patients.
- OST-HER2's 75% 2-year survival rate offers new hope for osteosarcoma patients, potentially transforming treatment outcomes for this aggressive cancer starting in early 2027.
- OS Therapies is spinning off its animal health division while advancing a cancer therapy that doubled 2-year survival rates in osteosarcoma patients compared to historical data.
Impact - Why it Matters
This development represents a potential breakthrough for osteosarcoma patients, particularly those with recurrent pulmonary metastases who currently face limited treatment options and poor survival rates. The 75% two-year survival rate demonstrated by OST-HER2 dramatically outperforms historical controls at 40%, suggesting this could become a new standard of care for a devastating pediatric and young adult cancer. For investors, the progress toward regulatory submissions and planned spin-off of OS Animal Health creates multiple value catalysts, while the broader oncology field gains insights into successful regulatory strategies using historical controls and real-world evidence. The treatment's success could also validate the listeria platform technology for other cancer applications, potentially accelerating development of additional immunotherapies.
Summary
Stonegate Capital Partners has updated its coverage of OS Therapies Inc. (NYSE: OSTX), highlighting significant progress in the company's lead oncology program. The biopharmaceutical company achieved major clinical and regulatory milestones in the third quarter of 2025 as it advances OST-HER2 toward commercialization for patients with recurrent, fully resected pulmonary metastatic osteosarcoma. Final two-year overall survival data from the 41-patient Phase 2b trial demonstrated compelling results, showing a 75% two-year survival rate for OST-HER2 compared to just 40% in historical controls. Particularly noteworthy was the 100% two-year survival among patients who remained event-free at the 12-month mark, reinforcing the treatment's durable benefit profile.
Building on a successful End-of-Phase 2 interaction with regulators, OS Therapies is preparing harmonized regulatory filings across multiple jurisdictions. The company expects to submit applications to both the UK MHRA and FDA around year-end, supported by its strategic partnership with Eversana and a comprehensive launch plan. Management anticipates initial Priority Review Voucher monetization in 2026 and commercial OST-HER2 revenues beginning in early 2027. In a significant corporate development following the quarter's end, the company announced its intent to spin off OS Animal Health into a separately financed, standalone public company in the first half of 2026, with current OSTX shareholders expected to receive direct equity participation in the new listing.
The company continues to leverage its acquired Ayala/Advaxis listeria platform across its pipeline, with the OST-504 Phase 1b trial in biochemically recurrent prostate cancer completing its last patient visit and initial data expected in the fourth quarter of 2025. Regulatory advancements have been substantial, with FDA alignment on safety, non-clinical, and chemistry, manufacturing, and controls requirements, while UK MHRA has accepted the use of historical controls and real-world comparators for a conditional marketing authorization application. The company has secured key regulatory meetings in the fourth quarter of 2025 and plans submissions under Project Orbis in January 2026, positioning OST-HER2 for potential approval in multiple markets.
Source Statement
This curated news summary relied on content disributed by Reportable. Read the original source here, OS Therapies Advances Breakthrough Osteosarcoma Treatment Toward Approval
