OS Therapies reported significant progress in the second quarter of 2025, particularly in the clinical and regulatory aspects of bringing a new treatment for osteosarcoma to the U.S. market.
Key highlights include FDA confirming OST-HER2 as a Regenerative Medicine Advanced Therapy (RMAT) and preparations for accelerated approval submission.
The company's commercial partnership with Eversana positions OST-HER2 for a potential U.S. launch in the first half of 2026.
FDA Confirmation
OST-HER2 meets biological definition of RMAT, paving the way for accelerated approval.
Capital Raise
Closed a $4.2 million capital raise via warrant exercise inducement and exchange offering, extending cash runway into mid-2026.
Commercial Partnership
Partnership with Eversana sets the stage for a potential U.S. launch of OST-HER2 in 2026.
Patent Approval
Granted new patent providing exclusivity for commercial manufacturing process through 2040.
International Expansion
Progress made with MHRA and EMA for regulatory approval processes in the UK and Europe.
- The statistically significant data from the Phase 2b trial of OST-HER2 in osteosarcoma treatment has positioned the company for accelerated approval pathways.
- Strong safety data and successful partnerships indicate a promising future for the company's product launch and regulatory approvals.
OS Therapies' positive financial results and regulatory advancements demonstrate the company's commitment to innovative cancer therapies and market expansion. With strategic partnerships and regulatory milestones achieved, OS Therapies is on track for significant growth.