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