Welcome to our dedicated page for Gilead Sciences news (Ticker: GILD), a resource for investors and traders seeking the latest updates and insights on Gilead Sciences stock.
Gilead Sciences develops and commercializes medicines for HIV, viral hepatitis, COVID-19 and cancer. Company updates regularly cover product sales and operating results, HIV franchises such as Biktarvy, Yeztugo and lenacapavir, and clinical or regulatory activity for investigational HIV regimens that combine established antiretroviral agents with newer mechanisms.
Recurring developments also include oncology pipeline expansion through Kite cell-therapy programs, the completed acquisition of Arcellx and its investigational BCMA-directed CAR T-cell therapy anitocabtagene autoleucel for multiple myeloma, collaboration activity using real-world evidence in oncology R&D, shareholder matters, and capital-structure disclosures tied to material agreements and acquisitions.
Gilead (Nasdaq:GILD) received U.S. FDA approval for Trodelvy as first-line treatment for unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC). Trodelvy can be used alone in PD-(L)1–ineligible patients or with Keytruda/Keytruda Qlex in PD-L1 CPS ≥10 tumors.
Approval is based on Phase 3 ASCENT-03 and ASCENT-04 data, where Trodelvy-based regimens reduced risk of progression or death by 38% and 35% versus chemotherapy-based comparators and extended median duration of response to 12.2 vs 7.2 months and 16.5 vs 9.2 months.
Gilead (Nasdaq:GILD) received European Commission approval for Trodelvy as first-line monotherapy for adults with unresectable or metastatic triple-negative breast cancer who have not had prior systemic metastatic therapy and are not candidates for PD-1/PD-L1 inhibitors.
The decision, covering the EU plus Norway, Iceland and Liechtenstein, is based on Phase 3 ASCENT-03, where Trodelvy cut the risk of progression or death by 38% versus chemotherapy. Trodelvy is the first antibody-drug conjugate and first new first-line treatment option in 20 years in Europe for this patient group and carries a boxed warning for severe neutropenia and diarrhea.
Gilead (Nasdaq:GILD) announced that the U.S. FDA has accepted its sNDA for once-weekly oral Yeztugo (lenacapavir) 300‑mg as investigational PrEP for HIV prevention. The FDA set a PDUFA date of February 2, 2027. The filing is supported by PURPOSE 1 and PURPOSE 2 trial results showing high efficacy in diverse populations. If approved, it could become the first long-acting oral PrEP option. Yeztugo’s current injectable PrEP indication and boxed warning emphasize strict HIV testing to reduce resistance risk.
Gilead (NASDAQ:GILD) announced a donation of more than 2,000 vials of intravenous remdesivir to Uganda to support the current Ebola Bundibugyo virus disease (BVD) outbreak. The medicine is supplied under compassionate use and MEURI frameworks, with additional supply being prepared.
Gilead is also preparing to support requests from the Democratic Republic of the Congo, WHO and other partners for remdesivir and obeldesivir as part of regional Ebola BVD response and planned clinical trials. Remdesivir shows promising preclinical activity across filoviruses but is not approved for filovirus disease, and its safety and efficacy for Bundibugyo strain remain under study.
The National AIDS Memorial and the Gilead Foundation (NASDAQ:GILD) announced a three-year, approximately $3 million commitment to expand HIV/AIDS education, leadership development, and historical preservation.
Funding supports the Pedro Zamora Young Leaders programs, AIDS Memorial Quilt re-digitization, public engagement initiatives, the National AIDS Memorial Grove, and the Surviving Voices documentary series.
Gilead and Merck (NYSE:MRK) reported positive topline Phase 3 results for once-weekly oral HIV regimen islatravir/lenacapavir (ISL/LEN). Both ISLEND-1 and ISLEND-2 met the Week 48 primary endpoint, showing statistical non-inferiority to daily BIKTARVY or standard of care, with generally comparable safety. The partners plan global regulatory filings.
Merck (NYSE: MRK) and Gilead announced discontinuation of the Phase 3 KEYNOTE-D46/EVOKE-03 study of Trodelvy plus KEYTRUDA versus KEYTRUDA alone in previously untreated metastatic NSCLC patients with PD-L1 TPS ≥50%.
The eDMC recommended stopping after PFS failed to reach statistical significance and OS is unlikely to do so; safety was consistent with known profiles and no new safety signals emerged.
Gilead (NASDAQ:GILD) highlighted collaborative efforts with the South African government, the Global Fund and the U.S. State Department via PEPFAR to launch lenacapavir, a long-acting HIV prevention medicine, in South Africa.
The company emphasizes royalty-free voluntary licenses with six manufacturers, enabling future generic supply across 120 low- and lower-middle-income countries and supporting local manufacturing to strengthen long-term access.
Gilead Sciences (Nasdaq:GILD) and Lakefront Biotherapeutics completed the acquisition of Ouro Medicines, adding clinical-stage T cell engager gamgertamig (OM336) to Gilead’s inflammation portfolio and Lakefront’s pipeline.
Gilead pays $1.675B upfront plus up to $500M milestones. Lakefront gains Ouro’s team and assets, 20%–23% royalties on gamgertamig, three preclinical autoimmune programs, and flexibility to deploy $500M cash, including up to $150M for share buybacks, with year-end 2026 cash expected around €2B.
Gilead (Nasdaq:GILD) reported Phase 3 IDEAL trial results showing Livdelzi (seladelpar) achieved statistically significant composite ALP normalization versus placebo at 52 weeks in adults with primary biliary cholangitis (PBC) and ALP 1–1.67×ULN on or intolerant to UDCA.
The 96‑patient study showed a generally consistent safety profile with prior Livdelzi trials and no new safety concerns. Gilead plans to present full data at a medical congress and discuss results with global regulators.