Curated News
By: NewsRamp Editorial Staff
September 30, 2026
OS Therapies' Osteosarcoma Treatment Advances Toward FDA Approval
TLDR
- OS Therapies' OST-HER2 therapy offers investors potential gains from FDA RMAT designation and a Priority Review Voucher worth up to $160M if approved by September 2026.
- OS Therapies uses a listeria-based immunotherapy platform with Phase 2b trial data showing statistically significant improvement in Event Free Survival for osteosarcoma patients.
- OST-HER2 provides hope for osteosarcoma patients with no new FDA-approved therapies in 40 years, potentially improving survival rates and quality of life.
- OS Therapies expanded into veterinary medicine with canine osteosarcoma trials while securing international regulatory synchronization through Project Orbis for faster global approvals.
Impact - Why it Matters
This development represents a potential breakthrough for pediatric and young adult cancer patients, particularly those with osteosarcoma who have had no new treatment options for over four decades. The accelerated regulatory pathway and strong clinical data suggest OST-HER2 could soon become available, offering hope for improved survival outcomes. For investors, the combination of clinical success, regulatory momentum, and financial positioning makes this a significant opportunity in the biotech sector, with potential for substantial returns given the orphan drug status and Priority Review Voucher possibility.
Summary
Stonegate Capital Partners has initiated coverage on OS Therapies Inc. (NYSE: OSTX), highlighting the company's significant progress with its lead immunotherapy candidate OST-HER2 for treating recurrent pulmonary metastatic osteosarcoma. The FDA has granted OST-HER2 Regenerative Medicine Advanced Therapy (RMAT) designation and issued a Biologics License Application number, paving the way for Accelerated Approval submission. Final Phase 2b trial results showed statistically significant improvement in Event Free Survival, supported by interim 2-year Overall Survival data, validating the therapy's clinical benefit in a disease with no new FDA-approved treatments in over 40 years.
OS Therapies has secured a U.S. commercial partnership with Eversana and is positioning for a potential launch in the first half of 2026. The company expanded its pipeline by acquiring Ayala's listeria immunotherapy platform, adding four clinical-stage and eight pre-clinical programs. Regulatory advancements include productive FDA meetings, alignment on CMC and non-clinical matters, and planned rolling BLA submissions beginning September 2025. Internationally, the company has submitted to UK MHRA and scheduled EMA meetings, with agencies signaling intent to synchronize reviews via Project Orbis.
Financially, OS Therapies reported a 2Q25 net loss of $4.5M, reflecting increased R&D and G&A expenses, but has strengthened its balance sheet through recent financing activities including warrant exchanges totaling $7.9M. Cash stood at $2.8M at quarter-end, with runway extended into 2027. The company's rare pediatric disease designation could qualify it for a Priority Review Voucher worth approximately $155-160M if approved before September 2026, providing additional capital for commercialization efforts.
Source Statement
This curated news summary relied on content disributed by Reportable. Read the original source here, OS Therapies' Osteosarcoma Treatment Advances Toward FDA Approval
