GILD · 10-Q · 2026Q2 · Full report

Product / Drug Pipeline Progress

GILEAD SCIENCES, INC. · 2026-08-06 · Importance 47 · Surprise 60

Gilead is expanding its HIV prevention and treatment portfolio, with FDA acceptance of a supplemental NDA for once-weekly oral Yeztugo and an NDA for bictegravir and lenacapavir under priority review. Hepcludex received accelerated FDA approval as the first and only FDA-approved treatment for HDV in the United States. In oncology, Trodelvy received FDA first-line approval for locally advanced or metastatic triple-negative breast cancer and European regulatory authorizations in related first-line settings. The FDA also accepted the BLA for anito-cel in fourth-line-or-later relapsed or refractory multiple myeloma, while Tecartus received full approval for relapsed or refractory mantle cell lymphoma.

Key facts

• Announced discontinuation of Phase 3 EVOKE-03 study (Trodelvy + Keytruda) for first-line metastatic NSCLC with TPS ≥50% based on Data Monitoring Committee recommendation following analyses of PFS and interim OS. source