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Gilead Sciences, Inc. (GILD) is a leading biopharmaceutical company focused on developing innovative therapies for life-threatening diseases. This page provides investors and healthcare professionals with timely updates on the company's latest developments, regulatory milestones, and strategic initiatives.
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Gilead Sciences (Nasdaq: GILD) received the 2025 Prix Galien USA Award for Best Pharmaceutical Product for Yeztugo® (lenacapavir).
Yeztugo is a twice-yearly injectable HIV-1 capsid inhibitor indicated for adults and adolescents ≥35kg as a new option for pre-exposure prophylaxis (PrEP). Developed over 17 years, lenacapavir blocks multiple HIV life-cycle stages, including nuclear entry and capsid assembly. The Prix Galien USA awards recognize scientific advances and were judged by a committee that includes Nobel laureates; this category had 18 FDA-approved nominees from the past five years. Yeztugo and Gilead have also been recognized on Fortune's Change the World list, TIME’s Best Inventions, and named 2024 Breakthrough of the Year by Science.
Gilead (Nasdaq: GILD) will present new clinical and real-world data at The Liver Meeting® 2025 (AASLD), Nov 7–11 in Washington, D.C.
Key highlights include late-breaking presentations on Livdelzi (seladelpar) for primary biliary cholangitis (PBC): real-world switches from obeticholic acid, a three-year interim analysis showing stable or improved liver stiffness, and long-term pruritus outcomes up to 30 months. Gilead will also present integrated analyses of bulevirtide in chronic hepatitis delta through pooled data up to 96 weeks and other viral hepatitis and HBV cure program updates.
Regulatory notes: Livdelzi received FDA accelerated approval (Aug 2024); a BLA for bulevirtide 10 mg was submitted to FDA on Sept 22, 2025 and is pending.
Gilead (Nasdaq: GILD) will present new virology data at IDWeek 2025 (Oct 19–22, 2025) covering HIV prevention and treatment, respiratory viruses, viral hepatitis and pandemic-potential viruses.
Key highlights include Phase 3 PURPOSE analyses reinforcing the safety of twice-yearly Yeztugo (lenacapavir) for PrEP across diverse populations, a Phase 4 EMPOWER interim finding that switching from IM CAB+RPV to Biktarvy maintained viral suppression with higher treatment satisfaction, and REDPINE/remdesivir analyses in high‑risk hospitalized COVID-19 patients. New preclinical and clinical data on obeldesivir, RSV, and hepatitis programs will also be presented.
Gilead (NASDAQ: GILD) reported Phase 3 ASCENT-03 results showing Trodelvy reduced the risk of disease progression or death by 38% (HR 0.62; p<0.0001) versus chemotherapy as first-line therapy in metastatic triple-negative breast cancer (TNBC) patients not eligible for PD-1/PD-L1 inhibitors.
Key efficacy: median PFS 9.7 months vs 6.9 months, ORR 48% vs 46%, and median DOR 12.2 months vs 7.2 months. Safety was consistent with prior studies; most frequent grade ≥3 events included neutropenia and diarrhea. Overall survival data were not mature. Results presented at ESMO 2025 and published in NEJM.
Gilead (Nasdaq: GILD) will present new HIV data at EACS 2025 (Oct 15–18) covering prevention and treatment advances.
Key points: twice-yearly lenacapavir for PrEP showed safety with concomitant meds and persistence in PURPOSE studies; a Phase 2 twice-yearly lenacapavir+bNAbs regimen maintained suppression to 52 weeks and is moving to Phase 3; an investigational once-weekly islatravir+lenacapavir oral regimen maintained viral suppression at 96 weeks (88.5% missing=failure; 100% missing=excluded); five-year real-world BICSTaR data show sustained suppression on Biktarvy.
Gilead (NASDAQ: GILD) will present new oncology data at ESMO 2025 (Oct 17–21), including late-breaking Phase 3 ASCENT-03 results showing Trodelvy met its primary endpoint with a highly statistically significant, clinically meaningful improvement in progression-free survival versus chemotherapy in first-line metastatic triple-negative breast cancer (TNBC) for patients not eligible for PD-1/PD-L1 inhibitors.
Gilead and Arcus will present EDGE-Gastric Arm A1 overall survival data: median OS 26.7 months with 50% of patients alive >2 years; immune-mediated TEAEs occurred in 22% and infusion reactions in 7%. Trodelvy regulatory approvals and safety warnings are summarized for investors.
Gilead Sciences (Nasdaq: GILD) will release its third quarter 2025 financial results and guidance on Thursday, October 30, 2025 after market close.
Management will host a webcast at 4:30 p.m. Eastern Time on the same day to discuss results and provide a business update. The live webcast will be available in the Investors section of www.gilead.com and will be archived there for one year.
Contact details: investor_relations@gilead.com and Gilead Public Affairs phone numbers provided for additional investor inquiries.
Gilead Sciences (NASDAQ:GILD) has announced a significant $6.5 million commitment in STEM education grants through the Gilead Foundation. The funding includes a $1 million grant to Boys and Girls Clubs of America, $500,000 to San Mateo Foster City Education Foundation, and $5 million to San Francisco State University for their Science and Engineering Innovation Center.
This initiative aims to address the projected shortfall of 1.4 million skilled STEM workers by 2030 in the U.S., with STEM skills expected to be essential for 80% of all jobs by the end of the decade. The investment builds on Gilead's broader commitment to the Bay Area, where the company has awarded over $150 million in grant funding to nearly 250 nonprofit organizations since 2018.
Ensoma, backed by Gilead (NASDAQ:GILD), has secured a $53 million financing round from existing investors to advance its in vivo hematopoietic stem cell (HSC) engineering platform. The funding will primarily support the company's recently initiated Phase 1/2 clinical trial of EN-374 for X-linked chronic granulomatous disease (X-CGD), which is now open for patient enrollment.
The investment syndicate includes notable participants such as Gilead, 5AM Ventures, Gates Foundation, and Viking Global Investors. As part of the investment, Gilead has appointed an executive to Ensoma's board. The company aims to develop one-time, outpatient treatments for serious diseases, with additional focus areas in immuno-oncology and sickle cell disease.