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.
Kite (Nasdaq: GILD) and Arcellx reported updated pivotal iMMagine-1 Phase 2 data for investigational anitocabtagene autoleucel (anito-cel) at ASH 2025 with a cutoff of Oct 7, 2025 and median follow-up of 15.9 months.
Key results: ORR 96%, sCR/CR 74%, MRD negativity 95% (≤10-5), 12/18/24-month PFS of 82.1%/67.4%/61.7%, and 12/18/24-month OS of 94%/88%/83%. Safety was described as predictable and manageable: CRS 86% (mostly Grade 1), ICANS 8% (one Grade 3), and no delayed non-ICANS neurotoxicities observed to date.
Gilead (Nasdaq: GILD) presented Phase 1 data at ASH 2025 showing encouraging efficacy and tolerability for two investigational bicistronic CAR T therapies, KITE-753 and KITE-363, targeting CD19 and CD20 with dual co-stimulation.
Key data: in KITE-753 dose level 3 (0.2×106 CAR T/kg) 11 of 14 CAR‑naïve patients (79%) had complete responses at median follow-up 2.9–4.0 months; across KITE-753 dose levels 14 of 20 CAR‑naïve patients achieved complete responses. KITE-363 showed durable remissions with median follow-up 17.5 months and >70% of evaluable complete responders at 12 months remaining in remission. No dose‑limiting toxicities reported.
Gilead Foundation (Nasdaq: GILD) committed over $3 million in Healing Hunger grants on November 24, 2025 to expand access to fresh food across California, North Carolina, New Jersey, Maryland, and Washington, D.C.
Grants fund 14 regional programs — mobile pantries, produce recovery, urban farming, and school distribution — with recipient targets such as 17 million pounds and 2.5 million pounds of food distributions in specific regions. The investment complements the Foundation's broader community giving and Gilead's recent 2025 U.S. investment announcement.
Aspen Neuroscience (GILD) closed a $115 million Series C financing on November 20, 2025 to advance its personalized autologous cell therapy programs. The round was co-led by OrbiMed, ARCH Venture Partners, Frazier Life Sciences, and Revelation Partners, with new participation from Kite, a Gilead company, and others.
Proceeds will support ongoing ANPD001 clinical trials, scale manufacturing for clinical/commercial demand, and advance additional iPSC-derived neurology programs. Total capital raised now exceeds $340 million, including an $8 million CIRM grant. Cindy Perettie of Kite will join the board.
Gilead (Nasdaq: GILD) announced first shipments of lenacapavir, a twice-yearly injectable for HIV pre-exposure prophylaxis (PrEP), to Eswatini and Zambia on Nov 18, 2025. The deliveries follow U.S., EU, South Africa and Zambia approvals and come five months after U.S. FDA approval. Gilead will supply lenacapavir at no profit for up to two million people until generics scale, and has royalty-free licences with six generic manufacturers covering 120 countries. Regulatory submissions for PrEP are planned in 18 additional countries by year-end 2025; further country arrivals, including South Africa, are expected in early 2026.
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.