Gilead Sciences Inc Stock Price, News & Analysis

Gilead (Nasdaq: GILD) and Kite will present 21 abstracts, including 5 oral presentations, at ASH 2025 (Dec 6–9), highlighting updated clinical data for anitocabtagene autoleucel (anito-cel), next-generation CAR T assets (KITE-363, KITE-753), and long-term Yescarta follow-up.

Key disclosed findings include updated Phase 2 iMMagine-1 results for anito-cel with no delayed neurotoxicities observed to date, dual-antigen CD19/CD20 design and dual co-stimulatory domains for KITE-363/KITE-753, and a joint analysis showing consistent efficacy, safety, and quality-of-life patterns for Yescarta across ZUMA-7 (4-year) and ALYCANTE (2-year) cohorts, supporting broader second-line use regardless of ASCT eligibility.

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.