GILD · 8-K · 20260804PR000028

Product / Drug Pipeline Progress

GILEAD SCIENCES, INC. · 2026-08-04 · Importance 47 · Surprise 60 · In source text

Gilead received FDA accelerated approval for Hepcludex, making it the first and only FDA-approved treatment for chronic hepatitis delta virus infection in the U.S. The FDA accepted a supplemental application for a potential once-weekly oral Yeztugo formulation for HIV PrEP, with a February 2, 2027 target action date. Gilead also reported positive Phase 3 results for the once-weekly islatravir and lenacapavir regimen in adults with virologically suppressed HIV. These developments expand the company’s HIV and viral hepatitis product offerings beyond its established Biktarvy and Descovy franchises.

Key facts

• The acquisition of Tubulis brings GS-8824 and a platform to develop novel ADCs source
• Announced positive Phase 3 results from ISLEND-1 and ISLEND-2 for investigational once-weekly islatravir 2 mg and lenacapavir 300 mg combination in virologically suppressed adults source
• Announced positive results from the Phase 3 IDEAL study supporting Livdelzi for people with PBC with elevated ALP levels between 1.0 and 1.67xULN source
• Presented updated Phase 1 results for KITE-753 at the 2026 European Hematology Association meeting source
• Announced discontinuation of the Phase 3 EVOKE-03 study evaluating Trodelvy plus Keytruda in 1L metastatic non-small cell lung cancer with high PD-L1 expression (TPS ≥50%) based on external Data Monitoring Committee recommendation source

Impact estimates