Gilead Sciences Inc Stock Price, News & Analysis

Gilead (Nasdaq: GILD) presented a pooled analysis at ASH 2025 showing consistent safety, efficacy, and quality-of-life benefits for Yescarta (axicabtagene ciloleucel) in relapsed/refractory large B-cell lymphoma (R/R LBCL), including patients ineligible for high-dose chemotherapy and autologous stem cell transplant.

Key pooled outcomes at two years: OS 64.9%, EFS 45.2%, and PFS 47.4%. Three-month complete metabolic response was 55.6%; 12-month duration of response was 61.0%. Safety pooled grade ≥3 TEAEs were 90.5%, with grade ≥3 neurologic events at 19.8%. Quality-of-life measures declined early then improved by Month 12 and Month 24.

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.