Gilead Sciences Inc Stock Price, News & Analysis

Gilead (NASDAQ: GILD) reported topline Phase 3 results from the ARTISTRY-1 trial on November 13, 2025. The once-daily investigational single-tablet regimen of bictegravir 75 mg/lenacapavir 50 mg met the primary Week 48 success criterion for non-inferiority versus participants' baseline multi-tablet antiretroviral regimens using the FDA snapshot (HIV-1 RNA ≥50 copies/mL).

The regimen was generally well tolerated with no new safety signals reported. Participants had baseline pill burdens of 2–11 pills/day and ~40% took antiretrovirals more than once daily. Gilead plans regulatory filings using ARTISTRY-1 and ARTISTRY-2 data and will present detailed findings at a future scientific congress.

Gilead (NASDAQ: GILD) announced that the Phase 3 ASCENT-07 study of Trodelvy (sacituzumab govitecan-hziy) versus physician’s choice chemotherapy in first treatment post-endocrine therapy for HR+/HER2-negative metastatic breast cancer did not meet its primary endpoint of blinded independent central review-assessed progression-free survival (PFS) per RECIST v1.1 on Nov 7, 2025. The study enrolled 654 patients randomized 2:1 and will continue to follow patients for overall survival (OS), a key secondary endpoint that was not mature at the primary analysis but showed an early trend favoring Trodelvy. Safety was consistent with prior Trodelvy studies and no new safety signals were identified.

Trodelvy remains approved for certain pre-treated HR+/HER2-negative and later-line TNBC indications and is being further evaluated in ongoing Phase 3 trials.

Gilead (NASDAQ: GILD) reported long‑term data (Nov 7, 2025) showing Livdelzi (seladelpar) sustained efficacy and tolerability in primary biliary cholangitis (PBC). In 396 real‑world patients (130 switched from obeticholic acid; 266 second‑line/monotherapy) most achieved ALP <1.67×ULN and 93% remained on treatment. ASSURE interim results: 85% maintained or improved liver stiffness up to 3 years; median change at Month 36 was −0.2 kPa (−2.9%), and high‑risk patients had −5.2 kPa (−29.7%).

Safety: no treatment‑related SAEs through 4 years; FDA granted accelerated approval Aug 2024.

Gilead Sciences (Nasdaq: GILD) announced executives will present at multiple investor conferences in Nov–Dec 2025: UBS Global Healthcare on Nov 10, 2025 at 11:00 AM ET, Jefferies Global Healthcare (London) on Nov 19, 2025 at 2:00 PM GMT, Citi Global Healthcare on Dec 2, 2025 at 11:15 AM ET, and Evercore Healthcare on Dec 3, 2025 at 10:50 AM ET.

Live webcasts will be available on the company investor site at investors.gilead.com, with replays accessible for at least 30 days after each presentation. Contact details and corporate background are provided for investor relations inquiries.

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.