OS Therapies (OSTX) said Wednesday its phase 2 OST-HER2 trial of an experimental treatment for lung metastatic osteosarcoma showed statistically significant results for the primary goal of 12-month event-free survival.
The company said the interim data from the ongoing 3-year overall survival secondary endpoint showed a strong trend in favor of the company's therapy in patients at both the 1-year and 2-year time points.
It added that all patients who reached the 12-month event-free survival endpoint remained alive.
"We are preparing to engage with the U.S. FDA on an accelerated pathway for approval in this extremely challenging indication," Paul Romness, MHP, Chair & CEO of OS Therapies, said.
Shares of the company rose more than 60% in premarket activity.
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