Chinese biotech Biyo Pharma says the US regulator has cleared its lead migraine biologic, BY002, to enter clinical trials, moving the project into first-in-human testing.
The company is positioning BY002 as an acute migraine treatment built for faster onset, longer-lasting relief, and better tolerability. It has not disclosed a target in its release, but it is landing in a field shaped in recent years by medicines aimed at the calcitonin gene-related peptide pathway.
Biyo says BY002 showed pharmacological activity and a favorable safety profile in preclinical work, including non-human primate models, ahead of the US FDA green light.
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