10:48 AM EDT, 06/30/2025 (MT Newswires) -- OS Therapies ( OSTX ) said Monday that one-year data from the phase 2b clinical trial of OST-HER2 in patients with fully resected, lung metastatic osteosarcoma showed a 35% event-free survival rate.

The company said the result was statistically significant compared with a 20% event-free survival rate in a peer-reviewed historical control group.

OS Therapies ( OSTX ) said it has submitted preliminary external control data and comprehensive plans to the US Food and Drug Administration to support a potential biologics license application under the agency's accelerated approval program.

The company also said the UK's Medicines and Healthcare products Regulatory Agency agreed to support efforts to develop external control data to assist with potential global marketing authorizations. If approved by September 2026, OST-HER2 may be eligible for a priority review voucher.

Shares of OS Therapies ( OSTX ) were up more than 9% in recent trading.

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