The FDA granted accelerated approval to Gilead Sciences’ Hepcludex (bulevirtide-gmod).

Hepcludex is the first and only U.S.-approved therapy for adults with chronic hepatitis delta virus (HDV).

The European Medicines Agency's CHMP also issued a positive opinion for Trodelvy as a monotherapy.

This recommendation targets adults with specific metastatic triple-negative breast cancer.

Gilead shares rose 3% on May 22 following these regulatory developments.