Gilead's Hepcludex achieves primary endpoint in late-stage trial for hepatitis D
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Gilead Sciences' (NASDAQ:GILD) Hepcludex (bulevirtide) achieved its primary endpoint at 48 weeks in a phase 3 trial for chronic hepatitis D.
At week 48, those who received Hepcludex at either 2 mg or 10 mg once daily achieved a significantly greater combined virological and biochemical response (45% and 48%, respectively) compared to those who did not receive the therapy.

The U.S. FDA has granted Breakthrough Therapy and Orphan Drug designations to Hepcludex.
Gilead submitted a Biologics License Application to the FDA in Q4 2021. Hepcludex has Conditional Marketing Authorization in the EU.
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