• Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • Settings
  • RSS Feeds
Quantisnow Logo
  • Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • Settings
  • RSS Feeds
PublishGo to App
    Quantisnow Logo

    © 2026 quantisnow.com
    Democratizing insights since 2022

    Services
    Live news feedsRSS FeedsAlertsPublish with Us
    Company
    AboutQuantisnow PlusContactJobsAI superconnector for talent & startupsNEWLLM Arena
    Legal
    Terms of usePrivacy policyCookie policy

    New ASCO and EHA 2026 Data Demonstrate Gilead and Kite's Momentum Across Antibody-Drug Conjugates and Cell Therapy in Oncology

    5/21/26 5:00:00 PM ET
    $GILD
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care
    Get the next $GILD alert in real time by email

    – ASCO Presentations on Trodelvy® in First-line Metastatic Triple-Negative Breast Cancer and Anito-cel in Relapsed or Refractory Multiple Myeloma Build Toward Potential Commercial Launches –

    – EHA Updates Include Durability of KITE-753, Kite's Enhanced DuoCore™ CAR T-cell Therapy –

    Gilead Sciences, Inc. (NASDAQ:GILD) today announced that together with Kite, a Gilead company, it will present more than 25 abstracts, including six oral presentations, at the 2026 ASCO Annual Meeting (May 29 – June 2) and the 2026 EHA Congress (June 11 – 14). These presentations underscore the increasing diversity of Gilead's oncology portfolio and pipeline reflecting a growing body of evidence across both solid tumors and hematologic malignancies. Collectively, the data demonstrate Gilead and Kite's leadership in antibody-drug conjugates (ADCs) and CAR T-cell therapy.

    Key presentations support continued momentum ahead of near-term potential launch opportunities, including new data analyses for Trodelvy® (sacituzumab govitecan-hziy) in first-line metastatic triple-negative breast cancer (mTNBC) and anitocabtagene autoleucel (anito-cel), an investigational agent for relapsed or refractory multiple myeloma (RRMM). Together with abstracts addressing earlier-stage innovation, manufacturing experience and real-world evidence, these data highlight a portfolio that is increasingly positioned to deliver durable impact at scale.

    "We are at a pivotal inflection point in the evolution of our oncology portfolio, with late-stage programs advancing alongside a rapidly maturing pipeline," said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. "The data we are presenting at ASCO and EHA highlight the trajectory we are building across antibody-drug conjugates and cell therapy, while reinforcing the clinical, manufacturing and operational foundation to sustain long-term leadership in oncology and deliver meaningful advances for people living with cancer."

    Key presentations at ASCO include:

    • ASCENT-04 and ASCENT-03 Analyses: Gilead will present new analyses during oral sessions from the Phase 3 ASCENT-04 and ASCENT-03 studies that further define the clinical profile of Trodelvy with or without Keytruda® (pembrolizumab) in first-line mTNBC, including evaluation of progression-free survival after next-line treatment (PFS2) in each study (Abstract #s LBA1000 and 1001). PFS2 is a measure that provides important context around durable, long-term clinical effect beyond the first progression. The ASCENT-04 PFS2 data for Trodelvy plus Keytruda will be shared as part of ASCO's press program.
    • Anito-cel Clinical Trial Manufacturing: Kite will present for the first time data on the anito-cel clinical trial manufacturing experience in patients with RRMM with at least one prior therapy or newly diagnosed MM from the Phase 3 iMMagine-3 and the Phase 2 GEM-AnitoFIRST study in collaboration with the GEM/PETHEMA Foundation, respectively. These findings highlight manufacturing consistency and operational execution supporting broader clinical development (Abstract #2550).
    • CAR T for the Treatment of Recurrent Glioblastoma: Research collaborators at the University of Pennsylvania Perelman School of Medicine will deliver an oral presentation featuring updated Phase 1 data exploring CAR T-cell therapy in recurrent glioblastoma, reflecting continued progress in advancing cell therapy approaches in solid tumors (Abstract #2013).

    Key presentations at EHA include:

    • KITE-753 Phase 1 Study: Updated Phase 1 results for KITE-753, Kite's enhanced DuoCore™ CAR T-cell therapy for relapsed/refractory B-cell lymphoma, showing encouraging safety and durability of efficacy results that support its continued development (Abstract #4208619).

    Summary of Presentations

    Accepted abstracts at the 2026 ASCO Annual Meeting can be found at www.ASCO.org and include:

    Title

    Abstract Details

    Breast Cancer

    Progression-free survival after next line of treatment (PFS2) and subsequent therapies (subs tx) in the ASCENT-04 study of participants (pts) with previously untreated PD-L1+ metastatic triple-negative breast cancer (mTNBC) treated with sacituzumab govitecan (SG) plus pembrolizumab (pembro) vs chemotherapy (chemo) plus pembro

    Abstract #LBA1000

    Oral Presentation

    June 2, 2026

    9:45 – 9:57 AM CDT

    Progression-free survival after next line of treatment (PFS2) and subsequent therapies (subs tx) in the ASCENT-03 study of participants (pts) with previously untreated metastatic triple-negative breast cancer (mTNBC) treated with sacituzumab govitecan (SG) vs chemotherapy (chemo)

    Abstract #1001

    Oral Presentation

    June 2, 2026

    9:57 – 10:09 AM CDT

    ASCENT-04: Analysis of efficacy by biomarker subgroups with sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in participants (pts) with previously untreated PD-L1+ metastatic triple-negative breast cancer (mTNBC)

    Abstract #1013

    Rapid Oral Presentation

    May 31, 2026

    11:30 – 11:36 AM CDT

    ASCENT-03: Efficacy by biomarker subgroup with sacituzumab govitecan (SG) vs chemotherapy (chemo) in participants (pts) with previously untreated advanced triple-negative breast cancer (TNBC) who are not candidates for PD-(L)1 inhibitors (PD-[L]1i)

    Abstract #1014

    Rapid Oral Presentation

    May 31, 2026

    11:36 – 11:42 AM CDT

    Using ML to predict rapid progression for patients (pts) with HR+/HER2- metastatic breast cancer (mBC) treated with frontline (1L) CDK 4/6 inhibitors (CDK 4/6i)

    Abstract #1025

    Poster Presentation

    June 1, 2026

    1:30 – 4:30 PM CDT

    Subgroup analysis of participants (pts) with HER2 IHC0 in the ASCENT-07 study of sacituzumab govitecan (SG) vs chemotherapy in HR+/HER2- metastatic breast cancer (mBC)

    Abstract #1065

    Poster Presentation

    June 1, 2026

    1:30 – 4:30 PM CDT

    Early deviations from guideline-concordant care in triple-negative breast cancer: A patient-reported analysis

    Abstract #e13528

    Online Publication Only

    May 21, 2026

    4:00 PM CDT

    Real-world utilization of a patient-centric symptom management guide for metastatic breast cancer

     

    Abstract #e23403

    Online Publication Only

    May 21, 2026

    4:00 PM CDT

    Ovarian Cancer

    NAPISTAR 1-01: Results of phase 1 dose escalation of monotherapy with TUB-040, a novel NaPi2b-targeting exatecan ADC, in patients (pts) with platinum-resistant ovarian cancer (PROC)

    Abstract #5513

    Rapid Oral Presentation

    May 30, 2026

    8:36 – 8:42 AM CDT

    Multiple Myeloma

    Anitocabtagene autoleucel (anito-cel) clinical trial manufacturing experience in patients with relapsed/refractory (RR) or newly diagnosed (ND) multiple myeloma (MM)**

    Abstract #2550

    Poster Presentation

    May 30, 2026

    1:30 – 4:30 PM CDT

    Glioblastoma

    Updated overall survival, safety, and neurologic function outcomes from a phase 1 trial of bivalent chimeric antigen receptor (CAR) T-cell therapy in recurrent glioblastoma (GBM)***

    Abstract #2013

    Rapid Oral Presentation

    May 31, 2026

    5:06 – 5:12 PM CDT

    Large B-cell Lymphoma

    KITE-753: A phase 2 study of an autologous anti-CD19/CD20 CAR T-cell therapy in CAR-naive patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL)

    Abstract #TPS7098

    Poster Presentation

    June 1, 2026

    9:00 AM – 12:00 PM CDT

    Long-term real-world outcomes of axicabtagene ciloleucel (axi-cel) in relapsed/refractory (R/R) large B-cell lymphoma (LBCL)

     

    Abstract #7028

    Poster Presentation

    June 1, 2026

    9:00 AM – 12:00 PM CDT

    CAR T-cell Therapy Resource Utilization

    Real-world healthcare resource utilization (HCRU) following chimeric antigen receptor (CAR) T-cell therapy in U.S. patients treated in new authorized treatment centers (ATCs) without FACT accreditation

    Abstract #e19515

    Online Publication Only

    May 21, 2026

    4:00 PM CDT

     

    *In collaboration with Viver Health

    **In collaboration with the GEM/PETHEMA Foundation

    ***Collaborative study with the University of Pennsylvania Perelman School of Medicine

    Accepted abstracts at the 2026 EHA Congress highlight Kite's expertise in CAR T-cell therapy and include:

    Title

    Abstract Details

    Large B-cell Lymphoma

    A Phase 1 Study of KITE-753 in Patients (Pts) With Relapsed/Refractory (R/R) B-Cell Lymphoma: Updated Safety and Efficacy Results

    Abstract #4208619

    Poster Presentation

    June 13, 2026

    6:45 – 7:45 PM CEST

    Axicabtagene Ciloleucel as Second-Line Treatment in Patients With Late-Relapsed Large B-Cell Lymphoma: Interim Analysis of the LATE-R Clinical Trial From the Spanish Lymphoma Group GELTAMO*

    Abstract #4207969

    Poster Presentation

    June 12, 2026

    6:45 – 7:45 PM CEST

    Clinical and Economic Outcomes by Risk Group Among First-Line Patients With Large B-Cell Lymphoma in the United States—SEER-Medicare Data Analysis

    Abstract #4210325

    Publication Only

    May 12, 2026

    Real-World (RW) Treatment Patterns and Survival Outcomes in Patients (Pts) With Newly Diagnosed High-Risk (HR) Large B-Cell Lymphoma (LBCL)

    Abstract #4206903

    Poster Presentation

    June 12, 2026

    6:45 – 7:45 PM CEST

    International Expert Consensus on Real-World CAR T-Cell Eligibility in Large B-Cell Lymphomas: An E-Delphi Study

    Abstract #4206912

    Poster Presentation

    June 12, 2026

    6:45 – 7:45 PM CEST

    Global Variation in CAR T-Cell Therapy Practice Patterns for LBCL: Quantitative Research Findings

    Abstract #4210262

    Publication Only

    May 12, 2026

    Axicabtagene Ciloleucel for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma in Brazil: The Impact of CAR T-Cell Therapy Wait Time and Treatment Sequencing

    Abstract #4210270

    Publication Only

    May 12, 2026

    Cost-Effectiveness of Axicabtagene Ciloleucel for Treating Taiwanese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma and High-Grade B-Cell Lymphoma After First-Line Treatment

    Abstract #4209065

    Poster Presentation

    June 13, 2026

    6:45 – 7:45 PM CEST

    Cost-Effectiveness of Axicabtagene Ciloleucel in Taiwanese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma and Primary Mediastinal B-Cell Lymphoma After Two Lines of Systemic Therapy

    Abstract #4207302

    Poster Presentation

    June 12, 2026

    6:45 – 7:45 PM CEST

    Mantle Cell Lymphoma

    Biologic Correlates of Long-Term Response After Brexucabtagene Autoleucel Therapy in Mantle Cell Lymphoma: Product Phenotype, PK, and Baseline Features

    Abstract #4208752

    Poster Presentation

    June 13, 2026

    6:45 – 7:45 PM CEST

    Acute Lymphoblastic Leukemia

    Cost-Effectiveness Analysis of Brexucabtagene Autoleucel in Adults With Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukaemia in Singapore

    Abstract #4209064

    Poster Presentation

    June 13, 2026

    6:45 – 7:45 PM CEST

    Non-Hodgkin Lymphoma

    Follow-Up-Time-Adjusted Non-Relapse Mortality (NRM) in Patients With Non-Hodgkin Lymphoma Following Chimeric Antigen Receptor (CAR) T-Cell Therapy Within Clinical Trials

    Abstract #4208663

    Poster Presentation

    June 13, 2026

    6:45 – 7:45 PM CEST

    Multiple Myeloma

    Anitocabtagene Autoleucel Clinical Trial Manufacturing Experience in Patients With Relapsed/Refractory or Newly Diagnosed Multiple Myeloma**

    Abstract #4209802

    Publication Only

    Cell Therapy Healthcare Resource Utilization

    CAR T Cell Therapy in Clinical Routine: Quantification of Real-World Hospital Resource Use Across CAR T Care Pathway in Germany

    Abstract #4207303

    Poster Presentation

    June 12, 2026

    6:45 – 7:45 PM CEST

     

    *Collaborative study with the Spanish Lymphoma Group GELTAMO

    **In collaboration with the GEM/PETHEMA Foundation

    The use of Trodelvy plus Keytruda in patients with first-line PD-L1+ metastatic TNBC and Trodelvy as monotherapy in patients with first-line metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitors are investigational, and the safety and efficacy of these uses have not been established.

    KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

    About Trodelvy

    Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and lung cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect.

    Trodelvy is currently approved in more than 60 countries for second-line or later metastatic triple-negative breast cancer (TNBC) and in more than 50 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer (mBC). Outside of Europe, Gilead has submitted supplemental applications to the U.S. Food and Drug Administration (FDA) for approval of Trodelvy based on the ASCENT-03 and ASCENT-04 studies.

    Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across a range of tumor types with high Trop-2 expression. These studies with Trodelvy, both in monotherapy and in combination with pembrolizumab, involve earlier lines of treatment for TNBC and HR+/HER2- breast cancer—including in curative settings—as well as in lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity.

    About Anito-cel

    Anitocabtagene autoleucel (anito-cel, previously ddBCMA) is the first BCMA-directed CAR T-cell therapy to be investigated in relapsed or refractory multiple myeloma that utilizes Arcellx's novel and compact binder known as the D-Domain. The small, D-Domain binder potentially enables high CAR expression without tonic signaling and is designed to quickly release from the BCMA target. This combination may allow for the potential elimination of multiple myeloma cells without severe immunotoxicity. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration.

    About KITE-753

    KITE-753 is an investigational, bicistronic autologous CAR T-cell therapy engineered to potentially overcome tumor antigen heterogeneity and may prevent relapse. The KITE DuoCore™ construct uniquely combines anti-CD19 and anti-CD20 targeting with dual co-stimulation (CD28 and 4-1BB). KITE-753 utilizes a novel manufacturing process, aiming to preserve T-cell fitness.

    U.S. INDICATIONS FOR TRODELVY

    TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:

    • Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
    • Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

    U.S. IMPORTANT SAFETY INFORMATION FOR TRODELVY

    BOXED WARNING: NEUTROPENIA AND DIARRHEA

    • TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
    • TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses.

    CONTRAINDICATIONS

    • Severe hypersensitivity reaction to TRODELVY.

    WARNINGS AND PRECAUTIONS

    Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI.

    Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤ Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.

    Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions.

    Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤ 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.

    Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.

    Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.

    ADVERSE REACTIONS

    In the pooled safety population, the most common (≥ 25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%).

    In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.

    In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes.

    DRUG INTERACTIONS

    UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY.

    UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY.

    Please see full Prescribing Information, including BOXED WARNING.

    About Gilead and Kite Oncology

    Gilead and Kite Oncology are working to transform how cancer is treated. We are innovating with next-generation therapies, combinations and technologies to deliver improved outcomes for people with cancer. We are purposefully building our oncology portfolio and pipeline to address the greatest gaps in care. From antibody-drug conjugate technologies and small molecules to cell therapy-based approaches, we are creating new possibilities for people with cancer.

    About Gilead Sciences

    Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif.

    Forward-Looking Statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead's ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials or studies, including those involving anito-cel, sacituzumab govitecan-hziy and KITE-753 (such as ASCENT-03, ASCENT-04, iMMagine-3 and GEM-AnitoFIRST); uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for programs and/or indications currently under evaluation, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

    Trodelvy, Gilead, the Gilead logo, Kite and the Kite logo are trademarks of Gilead Sciences, Inc., or its related companies.

    U.S. Prescribing Information for Trodelvy, including BOXED WARNING, is available at www.gilead.com.

    For more information about Gilead, please visit the company's website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).

    View source version on businesswire.com: https://www.businesswire.com/news/home/20260520344508/en/

    Priscilla White, Media

    public_affairs@gilead.com

    Jacquie Ross, Investors

    investor_relations@gilead.com

    Get the next $GILD alert in real time by email

    Crush Q1 2026 with the Best AI Superconnector

    Stay ahead of the competition with Standout.work - your AI-powered talent-to-startup matching platform.

    AI-Powered Inbox
    Context-aware email replies
    Strategic Decision Support
    Get Started with Standout.work

    Recent Analyst Ratings for
    $GILD

    DatePrice TargetRatingAnalyst
    5/20/2026$165.00Hold → Buy
    Maxim Group
    3/10/2026$180.00Buy
    Jefferies
    2/20/2026$155.00Equal Weight
    Barclays
    2/11/2026$140.00 → $170.00Buy
    Needham
    1/7/2026$145.00Buy
    UBS
    11/24/2025$140.00Buy
    Truist
    11/13/2025$140.00Sector Outperform
    Scotiabank
    8/19/2025$128.00Neutral → Outperform
    Daiwa Securities
    More analyst ratings

    $GILD
    FDA approvals

    Live FDA approvals issued by the Food and Drug Administration and FDA breaking news

    View All

    FDA Approval for HEPCLUDEX issued to GILEAD SCIENCES INC

    Submission status for GILEAD SCIENCES INC's drug HEPCLUDEX (ORIG-1) with active ingredient BULEVIRTIDE-GMOD) has changed to 'Approval' on 05/22/2026. Application Category: BLA, Application Number: 761468, Application Classification:

    5/26/26 6:57:56 AM ET
    $GILD
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    FDA Approval for BIKTARVY issued to GILEAD SCIENCES INC

    Submission status for GILEAD SCIENCES INC's drug BIKTARVY (SUPPL-26) with active ingredient BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE has changed to 'Approval' on 05/21/2026. Application Category: NDA, Application Number: 210251, Application Classification: Manufacturing (CMC)

    5/21/26 4:17:16 PM ET
    $GILD
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    FDA Approval for BIKTARVY issued to GILEAD SCIENCES INC

    Submission status for GILEAD SCIENCES INC's drug BIKTARVY (SUPPL-26) with active ingredient BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE has changed to 'Approval' on 05/21/2026. Application Category: NDA, Application Number: 210251, Application Classification: Labeling

    5/21/26 9:34:58 AM ET
    $GILD
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    $GILD
    Insider Trading

    Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

    View All

    Chairman & CEO O'Day Daniel Patrick sold $1,971,847 worth of shares (15,000 units at $131.46) as part of a pre-agreed trading plan, decreasing direct ownership by 2% to 617,567 units (SEC Form 4)

    4 - GILEAD SCIENCES, INC. (0000882095) (Issuer)

    6/2/26 6:04:05 PM ET
    $GILD
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    Chief Financial Officer Dickinson Andrew D sold $396,810 worth of shares (3,000 units at $132.27) as part of a pre-agreed trading plan, decreasing direct ownership by 2% to 173,191 units (SEC Form 4)

    4 - GILEAD SCIENCES, INC. (0000882095) (Issuer)

    5/18/26 5:50:30 PM ET
    $GILD
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    Chief Comm & Corp Aff Officer Mercier Johanna exercised 25,000 shares at a strike of $66.64 and sold $3,676,199 worth of shares (28,000 units at $131.29) as part of a pre-agreed trading plan, decreasing direct ownership by 2% to 125,779 units (SEC Form 4)

    4 - GILEAD SCIENCES, INC. (0000882095) (Issuer)

    5/18/26 5:45:39 PM ET
    $GILD
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    $GILD
    Press Releases

    Fastest customizable press release news feed in the world

    View All

    Gilead's Livdelzi® (Seladelpar) Delivers Statistically Significant Composite ALP Normalization in Phase 3 IDEAL Trial in Primary Biliary Cholangitis (PBC)

    – IDEAL Evaluated Livdelzi in People Living with PBC with Elevated ALP Levels (1-1.67xULN) on or Intolerant to UDCA – – 52-Week Results Demonstrate High and Sustained ALP Normalization and Generally Well-Tolerated Safety Profile – – Findings Add to Growing Evidence Supporting ALP Normalization as an Achievable Treatment Goal in PBC – Gilead Sciences, Inc. (NASDAQ:GILD) today announced positive results from a Phase 3 study in people with primary biliary cholangitis (PBC), showing that treatment with Livdelzi® (seladelpar) led to significantly more patients achieving normalization of alkaline phosphatase (ALP), a key liver marker of disease progression, compared with placebo after 52 we

    6/2/26 8:30:00 AM ET
    $GILD
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    Phase 3 ASSURE Interim Data: Majority of People in the Study with ALP 1–1.67×ULN Achieved High and Sustained Composite ALP Normalization at 24 Months with Gilead's Livdelzi (Seladelpar)

    – ALP Is a Key Marker of Disease Activity in People Living With PBC, With Elevations Above Normal Associated with Increased Risk of Disease Progression – – Further Analyses of the Phase 3 ASSURE Study Demonstrate Sustained ALP Normalization and Show Exploratory Outcomes of Stable or Improved Liver Stiffness, Providing Supportive, Long-term Evidence – Gilead Sciences, Inc. (NASDAQ:GILD) today shared new results from a post hoc analysis showing that Livdelzi® (seladelpar) was associated with high and sustained rates of normalization of a key liver marker (ALP) in people living with primary biliary cholangitis (PBC). In an ongoing Phase 3 study, participants with elevated ALP levels (betwe

    5/27/26 2:00:00 AM ET
    $GILD
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    FDA Grants Accelerated Approval to Gilead's Hepcludex® (bulevirtide-gmod), the First and Only Approved Treatment for Chronic Hepatitis Delta Virus (HDV)

    – Chronic HDV is considered the most severe form of viral hepatitis due to rapid disease progression towards liver failure and liver-related death – – Approval introduces the first FDA-approved therapy for this disease with limited treatment options and high unmet need – Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Hepcludex® (bulevirtide-gmod) 8.5 mg for the treatment of adults living with chronic hepatitis delta virus (HDV) infection, making it the first and only approved treatment for HDV in the United States. The FDA granted accelerated approval to Hepcludex based on reductions in HDV RNA

    5/22/26 2:00:00 PM ET
    $GILD
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    $GILD
    SEC Filings

    View All

    Gilead Sciences Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Creation of a Direct Financial Obligation, Other Events, Financial Statements and Exhibits

    8-K - GILEAD SCIENCES, INC. (0000882095) (Filer)

    5/20/26 4:15:36 PM ET
    $GILD
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    SEC Form 424B5 filed by Gilead Sciences Inc.

    424B5 - GILEAD SCIENCES, INC. (0000882095) (Filer)

    5/18/26 4:15:38 PM ET
    $GILD
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    SEC Form 144 filed by Gilead Sciences Inc.

    144 - GILEAD SCIENCES, INC. (0000882095) (Subject)

    5/15/26 4:07:18 PM ET
    $GILD
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    $GILD
    Analyst Ratings

    Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.

    View All

    Gilead Sciences upgraded by Maxim Group with a new price target

    Maxim Group upgraded Gilead Sciences from Hold to Buy and set a new price target of $165.00

    5/20/26 8:22:14 AM ET
    $GILD
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    Jefferies initiated coverage on Gilead Sciences with a new price target

    Jefferies initiated coverage of Gilead Sciences with a rating of Buy and set a new price target of $180.00

    3/10/26 8:40:41 AM ET
    $GILD
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    Barclays initiated coverage on Gilead Sciences with a new price target

    Barclays initiated coverage of Gilead Sciences with a rating of Equal Weight and set a new price target of $155.00

    2/20/26 8:24:53 AM ET
    $GILD
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    $GILD
    Insider Purchases

    Insider purchases reveal critical bullish sentiment about the company from key stakeholders. See them live in this feed.

    View All

    Gilead Sciences, Inc. converted options into 3,216,119 shares and bought $20,020,000 worth of shares (910,000 units at $22.00) (SEC Form 4)

    4 - GILEAD SCIENCES, INC. (0000882095) (Reporting)

    2/13/24 5:48:49 PM ET
    $GILD
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    $GILD
    Financials

    Live finance-specific insights

    View All

    Gilead Sciences Announces First Quarter Financial Results

    Product Sales Excluding Veklury Increased 8% Year-Over-Year to $6.8 billion Biktarvy Sales Increased 7% Year-Over-Year to $3.4 billion Gilead Sciences, Inc. (NASDAQ:GILD) announced today its results of operations for the first quarter 2026. "Gilead teams have delivered another strong quarter with 8% year-over-year growth in our base business and 10% growth in HIV, supported by the successful launch of Yeztugo. We have raised our full year revenue guidance as a reflection of our performance," said Daniel O'Day, Gilead's Chairman and Chief Executive Officer. "Building on the strongest pipeline in Gilead's history, we are adding potentially best-in-disease assets and platforms in oncolog

    5/7/26 4:01:00 PM ET
    $GILD
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    Gilead Sciences Completes Acquisition of Arcellx Ahead of Potential Commercial Launch of Anito-cel

    Gilead Sciences, Inc. (NASDAQ:GILD) today announced the successful completion of its previously announced acquisition of Arcellx, Inc. (NASDAQ:ACLX). Under the terms of the transaction, Gilead acquired Arcellx for $115 per share in cash, plus one non‑transferable contingent value right (CVR) of $5 per share, representing a total implied equity value of approximately $7.8 billion at the time of closing. The acquisition builds on Kite, a Gilead Company, and Arcellx's successful collaboration and provides Gilead with full control of anitocabtagene autoleucel (anito‑cel), an investigational BCMA‑directed CAR T‑cell therapy for multiple myeloma. By consolidating ownership of anito‑cel and elim

    4/28/26 8:45:00 AM ET
    $ACLX
    $GILD
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    Gilead Sciences to Release First Quarter 2026 Financial Results on Thursday, May 7, 2026

    Gilead Sciences, Inc. (NASDAQ:GILD) announced today that its first quarter 2026 financial results and guidance will be released on Thursday, May 7, 2026 after the market closes. At 4:30 p.m. Eastern Time that day, Gilead's management will host a webcast to discuss the company's first quarter 2026 financial results and provide a business update. A live webcast will be available in the Investors section of www.gilead.com and will be archived there for one year. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The compa

    4/22/26 4:05:00 PM ET
    $GILD
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    $GILD
    Leadership Updates

    Live Leadership Updates

    View All

    Gilead Sciences Appoints Keeley Wettan as Executive Vice President, General Counsel, Legal & Compliance

    Gilead Sciences, Inc. (NASDAQ:GILD) announced today that Keeley Wettan will be appointed Executive Vice President, General Counsel, Legal & Compliance effective immediately. She will join the company's senior leadership team and report to Chairman and Chief Executive Officer Daniel O'Day. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251218926462/en/Gilead Sciences appoints Keeley Wettan as Executive Vice President, General Counsel, Legal & Compliance Ms. Wettan has held increasingly senior legal leadership roles within Gilead during her 14-year tenure, most recently as Senior Vice President leading the Global Legal Business Par

    12/18/25 8:30:00 AM ET
    $GILD
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    The Institute for Follicular Lymphoma Innovation (IFLI) Appoints Innovative Leaders Mehrdad Mobasher, M.D., M.P.H., and Carol O'Hear, M.D., Ph.D., as Executive Partners

    DIAMOND BAR, Calif., Oct. 21, 2025 /PRNewswire/ -- The Institute for Follicular Lymphoma Innovation (IFLI), a global, non-profit, private foundation dedicated to accelerating the development of innovative treatment options for patients with follicular lymphoma (FL)., today announced the appointments of Mehrdad Mobasher, M.D., M.P.H., and Carol O'Hear, M.D., Ph.D., as Executive Partners. "I believe Carol and Mehrdad will be exceptional partners to the IFLI team and portfolio as they bring decades of strategic leadership and drug development expertise," said David McCullagh, Man

    10/21/25 8:05:00 AM ET
    $CRVS
    $DNA
    $EXEL
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Biotechnology: Biological Products (No Diagnostic Substances)

    Contineum Therapeutics Appoints Timothy Watkins, M.D., M.Sc., as Chief Medical Officer and Head of Development

    Contineum Therapeutics, Inc. (NASDAQ:CTNM) (Contineum or the Company), a clinical-stage biopharmaceutical company pioneering differentiated therapies for the treatment of neuroscience, inflammation and immunology (NI&I) indications, today announced the appointment of Timothy Watkins, M.D., M.Sc., to the Company's executive team as its Chief Medical Officer and Head of Development. Effective immediately, Dr. Watkins will lead all clinical development and medical affairs activities at Contineum. Dr. Watkins succeeds Stephen L. Huhn, M.D., who has been the Company's Chief Medical Officer since early 2020. Dr. Huhn will serve as an advisor during the leadership transition. "We're excited for D

    4/28/25 4:05:00 PM ET
    $CTNM
    $GILD
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Biotechnology: Biological Products (No Diagnostic Substances)

    $GILD
    Large Ownership Changes

    This live feed shows all institutional transactions in real time.

    View All

    SEC Form SC 13G/A filed by Gilead Sciences Inc. (Amendment)

    SC 13G/A - GILEAD SCIENCES, INC. (0000882095) (Subject)

    2/9/24 6:21:28 PM ET
    $GILD
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    SEC Form SC 13G/A filed by Gilead Sciences Inc. (Amendment)

    SC 13G/A - GILEAD SCIENCES, INC. (0000882095) (Subject)

    2/13/23 3:32:27 PM ET
    $GILD
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    SEC Form SC 13G filed by Gilead Sciences Inc.

    SC 13G - GILEAD SCIENCES, INC. (0000882095) (Subject)

    2/13/23 2:49:26 PM ET
    $GILD
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care