Articles from Gilead Sciences, Inc.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Medicines Agency (EMA) has validated for parallel accelerated review the company’s Marketing Authorization Application (MAA) and EU-Medicines for all (EU-M4all) application for lenacapavir—the company’s twice-yearly injectable HIV-1 capsid inhibitor—for the prevention of HIV as pre-exposure prophylaxis (PrEP).

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission (EC) has granted conditional marketing authorization for seladelpar for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA. Seladelpar (an orphan designated product) is now approved and will provide an important treatment option for people living with the rare liver disease in the European Economic Area (EEA).

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its executives will be speaking at the following investor conferences:

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for lenacapavir—the company’s twice-yearly injectable HIV-1 capsid inhibitor—for the prevention of HIV as pre-exposure prophylaxis (PrEP).

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company’s Board of Directors has declared an increase of 2.6% in the company’s quarterly cash dividend, beginning in the first quarter of 2025. The increase will result in a quarterly dividend of $0.79 per share of common stock. The dividend is payable on March 28, 2025, to stockholders of record at the close of business on March 14, 2025. Future dividends will be subject to Board approval.

Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the fourth quarter and full year 2024.

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its fourth quarter and full year 2024 financial results and 2025 guidance will be released on Tuesday, February 11, 2025, 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 fourth quarter and full year 2024 financial results and provide a business update.

Gilead Sciences, Inc. (Nasdaq: GILD) and LEO Pharma today announced a strategic partnership to accelerate the development and commercialization of LEO Pharma’s small molecule oral STAT6 (signal transducer and activator of transcription 6) programs for the potential treatment of patients with inflammatory diseases.

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its executives will be speaking at the following investor conference:

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Trodelvy® (sacituzumab govitecan-hziy) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed on or after platinum-based chemotherapy.

Gilead Sciences, Inc. (Nasdaq: GILD) and Terray Therapeutics, Inc. announced today that the companies have entered into a strategic collaboration to discover and develop novel, small molecule therapies across multiple targets.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending seladelpar for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA. The final European Commission decision is anticipated in the first quarter of 2025. This follows the accelerated approval by the U.S. Food and Drug Administration (FDA) in August 2024.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that Dietmar Berger, MD, PhD, will join the company on January 2, 2025, as Chief Medical Officer and will become a member of Gilead’s senior leadership team. Dr. Berger succeeds Merdad Parsey, MD, PhD.

Kite, a Gilead Company (Nasdaq: GILD), today announced results from a five-year follow-up analysis of ZUMA-5, a Phase 2 study of Yescarta® (axicabtagene ciloleucel) in patients with relapsed/refractory non-Hodgkin lymphomas (NHL) including follicular lymphoma (FL) or marginal zone lymphoma (MZL). The analysis demonstrated that after a median follow-up of more than five years, patients treated with Yescarta continued to experience durable response and long-term survival. The data were shared in an oral presentation (Abstract #864) during the 66th American Society of Hematology (ASH) Annual Meeting and Exposition.

Kite, a Gilead Company (Nasdaq: GILD), announced results today from four analyses that continue to demonstrate the durability of response of Tecartus® (brexucabtagene autoleucel) in patients with relapsed/refractory mantle cell lymphoma (R/R MCL) and relapsed/refractory B-cell precursor acute lymphoblastic leukemia (R/R B-ALL) during the 66th American Society of Hematology (ASH) Annual Meeting and Exposition.

Kite, a Gilead Company (Nasdaq: GILD), today announced findings from three new analyses for Yescarta® (axicabtagene ciloleucel) that demonstrate improved outcomes for people living with relapsed or refractory (R/R) large B-cell lymphoma (LBCL), which were presented at 66th American Society of Hematology (ASH) Annual Meeting & Exposition.

Gilead Sciences, Inc. (Nasdaq: GILD) and Tubulis today announced that they have entered into an exclusive option and license agreement to discover and develop an antibody-drug conjugate (ADC) against a solid tumor target.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced The New England Journal of Medicine (NEJM) published the full results from the company’s pivotal Phase 3 PURPOSE 2 trial evaluating twice-yearly lenacapavir for the investigational use of HIV prevention among a broad and geographically diverse range of cisgender men and gender-diverse people.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced data from a two-and-a-half-year interim analysis from the ongoing Phase 3 ASSURE study, which showed that 81% (30 out of 37) of participants with primary biliary cholangitis (PBC) treated with Livdelzi® (seladelpar) achieved a composite biochemical response (CBR), demonstrating significant improvements in a key measures of PBC progression. Additionally, 41% (15 out of 37) of participants achieved normalization of alkaline phosphatase (ALP) levels, a critical biomarker of liver function. These findings were unveiled as a late-breaker presentation at The Liver Meeting® 2024 hosted by the American Association for the Study of Liver Diseases (AASLD) in San Diego, California from November 15-19.

Gilead Sciences, Inc. (Nasdaq: GILD), a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, today announced the pricing of senior unsecured notes in an aggregate principal amount of $3.5 billion, in an underwritten, registered public offering, consisting of $750 million of 4.80% senior notes maturing in 2029, $1 billion of 5.10% senior notes maturing in 2035, $1 billion of 5.50% senior notes maturing in 2054 and $750 million of 5.60% senior notes maturing in 2064. The offering is expected to close November 20, 2024, subject to customary closing conditions.

Gilead Sciences, Inc. (Nasdaq: GILD) today presented the first in-depth look at full results from its pivotal Phase 3 PURPOSE 2 trial (NCT04925752), which is studying twice-yearly lenacapavir, the company’s injectable HIV-1 capsid inhibitor, for the investigational use of HIV prevention among a broad and geographically diverse range of cisgender men and gender-diverse people. Newly presented results include data on adherence to and pharmacokinetics of lenacapavir among trial participants.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of new research data from its innovative HIV treatment portfolio and pipeline, including a broad range of data on investigational and marketed agents with varied dosing frequencies and administration methods. The key findings presented at the International Congress on Drug Therapy in HIV Infection (HIV Glasgow 2024) reflect a transformative portfolio and future-looking pipeline focused on person-centered drug development strategies to address unmet needs in HIV treatment and help end the global epidemic.

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its executives will be speaking at the following investor conferences:

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the upcoming presentation of HIV research findings at the International Congress on Drug Therapy in HIV Infection (HIV Glasgow 2024), taking place from November 10-13. The results from more than 40 studies across HIV treatment and prevention include late-breaking data and seven oral presentations. These findings reflect a robust portfolio and future-looking pipeline focused on person-centered drug development strategies to address unmet needs in HIV and help end the epidemic.

Gilead Sciences, Inc. (Nasdaq: GILD) announced today its third quarter 2024 results of operations.

Kite, a Gilead Company (Nasdaq: GILD), will share 18 presentations, including six oral presentations, demonstrating the strength of its CAR T-cell therapy portfolio across a spectrum of blood cancers during the 66th American Society of Hematology (ASH) Annual Meeting and Exposition (December 7-10).

Gilead Sciences, Inc. (Nasdaq: GILD) today announced new research to be presented at The Liver Meeting® 2024, hosted by the American Association for the Study of Liver Diseases (AASLD) from November 15-19 in San Diego, Calif. More than 40 abstracts will be presented with key data, including 11 abstracts reporting new data on primary biliary cholangitis (PBC). The data will include findings from the RESPONSE trial that demonstrate the efficacy and safety profile of Livdelzi® (seladelpar) in people living with PBC and compensated cirrhosis. Additionally, data will be presented on the effects of Livdelzi on pruritus (chronic itching), a symptom that has significant impact on the quality of life of people living with PBC, along with interim long-term efficacy and safety results from the ongoing ASSURE study.

Gilead Sciences, Inc. (Nasdaq: GILD) and Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced new results from a Phase 2 clinical study evaluating the investigational combination of islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor, and lenacapavir, a first-in-class HIV-1 capsid inhibitor. These late-breaking data were presented during an oral session at IDWeek 2024, taking place in Los Angeles, and virtually, from October 16-19.

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its third quarter 2024 financial results and guidance will be released on Wednesday, November 6, 2024, 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 third quarter 2024 financial results and provide a business update.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the upcoming presentation of new findings from its antiviral research and development programs at IDWeek 2024, taking place from October 16-19. The data from 31 presentations across HIV treatment and prevention, COVID-19 and viral hepatitis include one late breaker abstract and six oral presentations, reflecting Gilead’s commitment to helping address the evolving needs of a diverse range of people and communities affected by some of the world’s most challenging viruses.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced additional data from its pivotal Phase 3 PURPOSE 2 trial (NCT04925752) providing an overview of the efficacy and safety of twice-yearly lenacapavir, the company’s injectable HIV-1 capsid inhibitor, for the investigational use of HIV prevention among a broad and geographically diverse range of cisgender men and gender-diverse people.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that it has signed non-exclusive, royalty-free voluntary licensing agreements with six pharmaceutical manufacturers to make and sell generic lenacapavir, subject to required regulatory approvals, in 120 high-incidence, resource-limited countries, which are primarily low- and lower-middle income countries. The agreements were signed in advance of any global regulatory submissions to enable these countries to quickly introduce generic versions of lenacapavir for HIV prevention, if approved.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the results of an interim analysis from a second pivotal Phase 3 clinical trial investigating the use of the company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir. Lenacapavir reduced HIV infections by 96% compared to background HIV incidence (bHIV). There were 2 incident cases among 2,180 participants, corresponding to 99.9% of participants not acquiring HIV infection in the lenacapavir group. Twice-yearly lenacapavir also demonstrated superiority to once-daily Truvada® (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg; F/TDF).

Gilead Sciences, Inc. (Nasdaq: GILD) and Genesis Therapeutics, Inc. announced today that the companies have entered into a strategic collaboration to discover and develop novel, small molecule therapies across multiple targets.

Gilead Sciences, Inc. (Nasdaq: GILD) will present new data from the company’s broad lung cancer clinical development program during the IASLC 2024 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer, taking place Sept. 7-10, 2024 in San Diego, Calif. Data to be highlighted across three oral presentations include: initial results from two cohorts of the EVOKE-02 study of Trodelvy® (sacituzumab govitecan-hziy) in previously untreated advanced or metastatic non-small cell lung cancer (mNSCLC), results from a subgroup analysis of the EVOKE-01 study of Trodelvy in second-line mNSCLC, and updated data from the TROPiCS-03 study of Trodelvy in extensive stage small cell lung cancer (ES-SCLC).

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its executives will be speaking at the following investor conferences:

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi® (seladelpar) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The use of Livdelzi is not recommended for people who have or develop decompensated cirrhosis.

Gilead Sciences, Inc. (Nasdaq: GILD) announced today its second quarter 2024 results of operations.

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its second quarter 2024 financial results and guidance will be released on Thursday, August 8, 2024, 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 second quarter 2024 financial results and provide a business update.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of key data from its innovative HIV treatment portfolio and research pipeline, including a broad range of investigational and marketed agents with varied dosing frequencies and administration methods. The findings presented at the 25th International AIDS Conference (AIDS 2024) reflect a portfolio and future-looking pipeline focused on person-centered drug development strategies to help address unmet needs in HIV treatment.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced full efficacy and safety results from its pivotal, Phase 3 PURPOSE 1 trial. Detailed data from the trial’s interim analysis announced in June showed that lenacapavir, the company’s twice-yearly injectable HIV-1 capsid inhibitor, demonstrated zero infections, 100% efficacy and superiority to background HIV incidence for the investigational use of HIV prevention in cisgender women (women assigned female at birth). Lenacapavir also demonstrated superior prevention of HIV infections when compared with once-daily oral Truvada (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF).

Gilead Sciences, Inc. (Nasdaq: GILD) and the Elton John AIDS Foundation (EJAF) today announced a five-year extension of the RADIAN® partnership to help meet the needs of the most vulnerable key populations in Eastern Europe and Central Asia (EECA) where the HIV epidemic is growing. RADIAN will continue supporting the initiatives of trusted, grassroots organizations who are working to address HIV-related challenges in the region.

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that Chief Medical Officer Merdad Parsey, MD, PhD, will leave the company early next year. While the company works to identify a successor, Dr. Parsey will continue as Chief Medical Officer until the first quarter of 2025 and support this transition over the next several months.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced its program for the upcoming 25th International AIDS Conference (AIDS 2024), taking place in Munich, Germany, and virtually, from July 22-26. As the leading innovator in HIV, Gilead will share new data from its research and development programs and Gilead-supported collaborations that unite leading scientific innovation and partnership aimed at ending the HIV epidemic.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from an interim analysis of its pivotal, Phase 3 PURPOSE 1 trial indicating that the company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, demonstrated 100% efficacy for the investigational use of HIV prevention in cisgender women.

Kite, a Gilead Company (Nasdaq: GILD), today announced results from three new analyses for Yescarta® (axicabtagene ciloleucel) in relapsed/refractory (R/R) large B-cell lymphoma (LBCL), including both new clinical research and real-world evidence highlighting manufacturing and product characteristics of Yescarta, and outpatient administration of both Yescarta and Tecartus® (brexucabtagene autoleucel) at the 2024 European Hematology Association (EHA) Annual Congress, June 13-16, Madrid.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced data from the Phase 2b MYR204 open-label study assessing the efficacy and safety of the first-in-class entry inhibitor bulevirtide as monotherapy and in combination with pegylated interferon alfa-2a (PegIFN), in adults living with compensated chronic hepatitis delta virus (HDV) infection. Published in the New England Journal of Medicine (NEJM), the data demonstrate that the investigational combination of bulevirtide 10 mg with PegIFN was superior to investigational bulevirtide 10 mg monotherapy in achieving undetectable HDV RNA (lower limit of quantification (LLOQ), target not detected) at Week 24 after the end of treatment (EOT). The end of study data presented at the European Association for the Study of the Liver (EASL) Congress 2024, demonstrate that treatment with bulevirtide 10 mg in combination with PegIFN maintained a 46% rate of undetectable HDV RNA at Week 48 after EOT, confirming its potential as a finite therapy for adults living with chronic HDV. HDV affects an estimated 5% of people living with chronic hepatitis B (HBV), with a global prevalence of more than 12 million people.

Gilead Sciences, Inc. (Nasdaq: GILD), following the recent acquisition of CymaBay Therapeutics, Inc., today announced two-year interim results from the ongoing ASSURE study of investigational seladelpar for the treatment of primary biliary cholangitis (PBC), a rare, chronic inflammatory liver disease. The two-year interim analysis includes people living with PBC who participated in any prior clinical studies of seladelpar (legacy studies) and participants from the pivotal Phase 3 RESPONSE study. Results demonstrated rapid and sustained improvements in markers of cholestasis, including high rates of normalization of liver biomarkers and a clinically meaningful reduction in pruritus (itch). These most recent data were shared in a presentation during the European Association for the Study of the Liver (EASL) Congress 2024 in Milan, Italy.

Kite, a Gilead Company (Nasdaq: GILD), today announced updated, four-year overall survival (OS) data from the pivotal ZUMA-3 study evaluating the CAR T-cell therapy Tecartus® (brexucabtagene autoleucel) in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL). The findings showed a median OS of 25.6 months and a four-year OS rate of 40% (95% CI, 28-52) in all treated patients with a safety profile consistent with that observed in the three-year analysis. The results were presented today in a poster presentation (Abstract #6531) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

Kite, a Gilead Company (Nasdaq: GILD), announced data from a pilot study in collaboration with Dana-Farber Cancer Institute that demonstrate Yescarta® (axicabtagene ciloleucel) is well-tolerated in patients living with relapsed or refractory (R/R) primary or secondary central nervous system lymphoma (PCNSL and SCNSL). The findings, which also suggest a trend in efficacy, were presented today in an oral session (Abstract #2006) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

Gilead Sciences, Inc. (Nasdaq: GILD) and Arcus Biosciences, Inc. (NYSERCUS) today announced new data from Cohort B of ARC-9, a Phase 1b/2 study evaluating the safety and efficacy of etrumadenant, a dual A2a/b adenosine receptor antagonist, plus anti-PD-1 monoclonal antibody zimberelimab, FOLFOX chemotherapy and bevacizumab (EZFB) in third-line metastatic colorectal cancer (mCRC). These results will be presented today during an oral session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting by Zev A. Wainberg, M.D., MSc, Co-Director of the GI Oncology Program at University of California Los Angeles and a principal investigator of the ARC-9 trial (Abstract 3508).

Gilead Sciences, Inc. (Nasdaq: GILD) and Arcus Biosciences, Inc. (NYSERCUS) today announced longer-term efficacy and safety results from Arm A1 of the Phase 2 EDGE-Gastric study. These updated data show consistent objective response rate (ORR) and provide mature progression-free survival (PFS) in patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma (upper GI cancers). The ongoing, multi-arm, global Phase 2 EDGE-Gastric study is evaluating the safety and efficacy of various combinations of the Fc-silent anti-TIGIT antibody domvanalimab plus the anti-PD-1 monoclonal antibody zimberelimab and chemotherapy in this patient population. These results will be presented today during the American Society of Clinical Oncology (ASCO) Plenary Series: Rapid Abstract Updates session by Yelena Y. Janjigian, M.D., Chief, Gastrointestinal Oncology, Memorial Sloan Kettering Cancer Center, and a principal investigator for the EDGE-Gastric study (Abstract 433248).

Gilead Sciences, Inc. (Nasdaq: GILD) today announced detailed results from the Phase 3 EVOKE-01 study that will be presented during an oral session (Abstract #LBA8500) today (2:45-5:45pm CT) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The results were also published simultaneously in the Journal of Clinical Oncology. The company previously announced that the study did not meet the primary endpoint of overall survival (OS) in previously treated metastatic non-small cell lung cancer (NSCLC).

Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from the confirmatory Phase 3 TROPiCS-04 study in locally advanced or metastatic urothelial cancer (mUC). The TROPiCS-04 study evaluated Trodelvy® (sacituzumab govitecan-hziy; SG) vs. single-agent chemotherapy (treatment of physicians’ choice, TPC) in patients with mUC who have previously received platinum-containing chemotherapy and anti-PD-(L)1 therapy.

Gilead Sciences, Inc. (Nasdaq:GILD) today announced new research to be presented at the European Association for the Study of the Liver (EASL) Congress, June 5-8, 2024 in Milan, Italy. Key findings from more than 25 abstracts will include:

Gilead Sciences, Inc. (Nasdaq: GILD), following the recent acquisition of CymaBay Therapeutics, Inc., today announced interim results from the ongoing ASSURE study demonstrating treatment with seladelpar, an investigational PPAR delta agonist, led to improvements in markers of cholestasis and reduced inflammation. Additional findings demonstrate that seladelpar can help reduce pruritus (itch) in people living with primary biliary cholangitis (PBC). There are currently no treatments indicated to treat PBC-related pruritis. This data will be shared in an oral presentation during the Presidential Plenary of the Digestive Disease Week® 2024 Conference in Washington, DC.

Kite, a Gilead Company (Nasdaq: GILD), today announced 12 abstracts from its industry-leading Chimeric Antigen Receptor (CAR) T-cell therapy portfolio at the upcoming 2024 European Hematology Association (EHA) Annual Congress, June 13-16, Madrid, Spain.

Kite, a Gilead Company (NASDAQGILD), and Arcellx, Inc. NASDAQ: ACLXNASDAQACLX)

Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, will present 18 abstracts during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. These data showcase the ongoing commitment to developing differentiated approaches to transform how cancer is treated and span solid tumors and blood cancers, including lung, breast, gastrointestinal, colorectal, leukemia and lymphoma.

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its executives will be speaking at the following investor conferences:

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) approved an updated label with additional data reinforcing the safety and efficacy profile of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to treat pregnant people with HIV-1 (PWH) with suppressed viral loads. These additional data stem from Study 5310, which evaluated the pharmacokinetics, safety and efficacy of Biktarvy in pregnant PWH who have suppressed viral loads and no known resistance to any components of Biktarvy in their second and third trimesters and through a median of 16 weeks postpartum. This update makes Biktarvy the only second-generation integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) with in-label clinical trial data and FDA approval in virologically suppressed adults who are pregnant. The U.S. Department of Health and Human Services (DHHS) perinatal guidelines recognize Biktarvy as having sufficient data to support being recommended as an alternative complete regimen for use in pregnancy and for people who are trying to conceive. Additionally, guidelines recommend continuing Biktarvy for PWH already on treatment who are virologically suppressed and tolerating treatment well who may become pregnant.

Gilead Sciences, Inc. (Nasdaq: GILD) announced today its first quarter 2024 results of operations.

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its first quarter 2024 financial results and guidance will be released on Thursday, April 25, 2024, 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 2024 financial results and provide a business update.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Vemlidy® (tenofovir alafenamide) 25 mg tablets as a once-daily treatment for chronic hepatitis B virus (HBV) infection in pediatric patients six years of age and older and weighing at least 25 kg with compensated liver disease.

Gilead Sciences, Inc. (Nasdaq: GILD) and Xilio Therapeutics, Inc. (Nasdaq: XLO) today announced an exclusive license agreement to develop and commercialize Xilio’s Phase 1 tumor-activated IL-12 program, XTX301.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) with respect to Gilead’s cash tender offer for CymaBay Therapeutics, Inc. expired at 11:59 p.m. on March 8, 2024.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from three studies evaluating the efficacy and safety profile of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) for a broad range of people with HIV, including those with HIV/hepatitis B (HBV) coinfection and HIV/tuberculosis (TB) coinfection. These data and other studies supporting the important role of Biktarvy in the HIV treatment landscape were presented at the 31st Conference on Retroviruses and Opportunistic Infections (CROI).

Gilead Sciences, Inc. (Nasdaq: GILD) and Merck (NYSEMRK), known as MSD outside of the United States and Canada, today announced results from the Phase 2 clinical study evaluating the investigational combination of islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor, and lenacapavir, a first-in-class capsid inhibitor. These late-breaking data were presented during an oral session at the 31st Conference on Retroviruses and Opportunistic Infections (CROI). Prior to the late-breaker oral presentation, the key findings were featured in a CROI press conference.

Gilead Sciences, Inc. (Nasdaq:GILD) and Merus N.V. (Nasdaq:MRUS) today announced a research collaboration, option and license agreement to discover novel dual tumor-associated antigens (TAA) targeting trispecific antibodies. Gilead and Merus agreed to collaborate on the use of Merus’ proprietary Triclonics® platform along with Gilead’s oncology expertise to research and develop multiple, separate preclinical research programs.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from three real-world retrospective studies being presented at the 31st Conference on Retroviruses and Opportunistic Infections (CROI).

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of key data highlighting the breadth of its innovative HIV treatment research pipeline. The latest results explore clinical outcomes from a study evaluating an investigational combination regimen of bictegravir and lenacapavir, new findings from a study evaluating the investigational combination of lenacapavir with broadly neutralizing antibodies (bNAbs), and new proof-of-concept data on GS-1720, a novel once-weekly integrase strand transfer inhibitor (INSTI). The data presented at the 31st Conference on Retroviruses and Opportunistic Infections (CROI) demonstrate Gilead’s commitment to advancing the next wave of biomedical innovations in HIV to address the unmet needs of people with the virus and help end the epidemic worldwide.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced it is providing a total of $12.6 million in grant funding to 19 organizations working to improve the HIV landscape for Black women and girls in the United States. These grants are a part of Gilead’s new Setting the P.A.C.E. (Prevention, Arts and Advocacy, Community, Education) initiative, a three-year commitment toward increasing HIV prevention, anti-stigma and health equity efforts for Black cisgender and Transgender women and girls, who are disproportionately impacted by the HIV epidemic.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) approved a new, expanded indication for Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to treat people with HIV (PWH) who have suppressed viral loads with known or suspected M184V/I resistance, a common form of treatment resistance. HIV treatment resistance is permanent and irreversible, which can jeopardize future treatment options for PWH. The M184V/I resistance mutation has been found to be present in a range (22-63%) of PWH with pre-existing resistance to nucleoside reverse transcriptase inhibitors (NRTIs) across various HIV subtypes. This label update is supported by Study 4030, which evaluated the efficacy, safety, and tolerability profile of Biktarvy in a broad range of people with HIV-1 with or without pre-existing NRTI resistance, including those with the M184V/I resistance. Biktarvy is now the first and only integrase strand transfer inhibitor (INSTI)-based single-tablet regimen that is FDA approved and U.S. Department of Health and Human Services (DHHS) guideline recommended for PWH who are virally suppressed with M184V/I resistance.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the upcoming presentation of new clinical data and real-world evidence (RWE) from its antiviral research and development programs at the 31st Conference on Retroviruses and Opportunistic Infections (CROI 2024) taking place from March 3-6. The data from nearly eighty studies across HIV, COVID-19 and viral hepatitis include late-breaking data, four oral presentations, and reflect Gilead’s commitment to address the evolving needs of a diverse range of people and communities affected by some of the world’s most challenging viruses.

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its executives will be speaking at the following investor conferences: