-- OS Therapies (OSTX) said Thursday the European Medicines Agency, or EMA, has initiated a rolling review for the conditional marketing authorization of OST-HER2, aimed at preventing recurrence in fully resected pulmonary metastatic osteosarcoma.
The company was also selected for the EMA's Raw Data Pilot program and, along with Australian regulators, agreed to use seroconversion data as a surrogate efficacy endpoint to support early market access.
Australia's Therapeutic Goods Administration has also invited OS Therapies to make an application for provisional determination, the equivalent of a conditional marketing authorization for OST-HER2, with a decision on a rolling review expected in Q3 2026.
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