09:29 AM EST, 02/14/2025 (MT Newswires) -- OS Therapies ( OSTX ) said Friday it has signed agreements to begin commercial manufacturing of its lead asset OST-HER2 as it prepares for a potential Biologics License Application submission to the US Food and Drug Administration.

The company said it is compiling additional data from its recently completed phase 2b trial of OST-HER2 for lung metastatic osteosarcoma recurrence prevention.

It plans to meet with the FDA for regulatory discussions before submitting a BLA for accelerated or conditional approval, OS Therapies ( OSTX ) added.

Shares of the company were up more than 36% in recent Friday premarket activity.