Gilead Sciences Stock Gains 21% YTD: Buy, Sell or Hold?
Biotech giant Gilead Sciences, Inc. GILD has put up a strong performance amid a volatile market. Shares of this biotech giant have gained 21.1% year to date against the industry's decline of 4.7%. The stock has outperformed the sector and the S&P 500 Index in this timeframe.
Image Source: Zacks Investment Research
Gilead Sciences is a dominant player in the HIV market with market-leading treatments. Its diverse portfolio also includes drugs for liver, hematology/oncology and inflammation/respiratory diseases.
Approval of new drugs, encouraging pipeline progress and positive data readouts have boosted investors' sentiment in the past six months. However, the oncology business is under pressure.
Let's delve into GILD's strengths and weaknesses to analyze how to play the stock at present.
Gilead's flagship drug, Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg, BIC/FTC/TAF), for HIV-1 infection has become the number-one prescribed regimen for both treatment-naïve and switch patients. Biktarvy accounts for over 51% share of the treatment market in the United States and should maintain momentum for GILD in the upcoming quarters.
Descovy (FTC 200 mg/TAF 25 mg) for pre-exposure prophylaxis (PrEP) is also witnessing good uptake. It maintains over 40% market share in the PrEP market in the United States.
Gilead's efforts to innovate its HIV portfolio are impressive. Late-stage studies, PURPOSE 1 and PURPOSE 2, validated lenacapavir's potential to prevent HIV. The FDA accepted new drug application submissions for twice-yearly lenacapavir for HIV prevention under priority review, with a target action date of June 19, 2025.
The European Medicines Agency validated the Marketing Authorization Application and EU-Medicines for All application for twice-yearly lenacapavir for HIV prevention.
The successful development and potential approval of lenacapavir for the prevention of the disease should solidify Gilead's HIV franchise.
Per GILD, lenacapavir, with its twice-yearly dosing, could set a new bar for HIV prevention and allow PrEP to reach a larger number of people who could benefit from a prevention regimen.
The FDA approval of seladelpar for the treatment of primary biliary cholangitis (PBC) has strengthened GILD's liver disease portfolio and validated its CymaBay acquisition. The drug's initial uptake is encouraging.
The candidate was approved under the brand name Livdelzi. Gilead also recently received conditional marketing authorization from the European Commission for seladelpar for the treatment of PBC.
Gilead's oncology portfolio, comprising the Cell Therapy franchise and breast cancer drug Trodelvy, has diversified its overall business. However, the Cell Therapy franchise, comprising Yescarta and Tecartus, is currently under pressure due to competitive headwinds in the United States and Europe that are expected to continue in 2025.
Breast cancer drug Trodelvy's sales were lower than expected in the first quarter due to inventory dynamics.
Gilead announced positive top-line results from the phase III ASCENT-03 study on Trodelvy, which showed highly statistically significant and clinically meaningful improvement in progression-free survival in patients with first-line metastatic triple-negative breast cancer (mTNBC) who are not candidates for checkpoint inhibitors.
The potential launch of anito-cel in multiple myeloma and Trodelvy in first-line mTNBC in 2026 will strengthen the company's oncology business.
From a valuation standpoint, GILD is expensive. According to the price/earnings ratio, GILD's shares currently trade at 13.70x forward earnings, lower than the large-cap pharma industry's average of 14.62X but higher than its mean of 10.53X.Image Source: Zacks Investment Research
Earnings estimates for GILD have moved north in the past 60 days. The bottom-line estimate for 2025 has increased to $7.91 from $7.87, while that for 2026 has improved to $8.39 from $8.31.
Image Source: Zacks Investment Research
Large biotech companies are generally considered safe havens for investors interested in this sector as they are well equipped to weather the uncertain macroenvironment.
GILD is one of the dominant players in the HIV market. Gilead's efforts to constantly innovate its HIV portfolio should enable it to maintain growth amid competition from GSK plc GSK. GILD has also collaborated with Merck MRK to evaluate the investigational combination of islatravir and lenacapavir for the treatment of HIV. The potential launch of lenacapavir for PrEP in 2025 will be a significant boost for the company.
Gilead's strategic deals and acquisitions to diversify its business are encouraging. However, Biktarvy sales are expected to be under pressure due to Medicare Part D redesign, which, in turn, should impact overall HIV growth.
Hence, we advise prospective investors to wait and watch how well Biktarvy and the oncology business combat the existing headwinds before making a positive investment decision. In addition, we believe investors should also wait for better entry levels.
For investors already owning the stock, it's important to note that Gilead has been consistently increasing and paying out dividends. The company declared a quarterly dividend of $0.79 per share of common stock for the second quarter of 2025. Its strong cash position (as of March 31, 2025, GILD had $7.9 billion of cash, cash equivalents and marketable debt securities) indicates that the current yield of 2.91% is sustainable.
Gilead presently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
GSK PLC Sponsored ADR (GSK) : Free Stock Analysis Report
Merck & Co., Inc. (MRK) : Free Stock Analysis Report
Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report
This article originally published on Zacks Investment Research (zacks.com).
Zacks Investment Research
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
30 minutes ago
- Yahoo
Blood test-guided treatment with AstraZeneca pill cut risk of breast cancer progression, study finds
By Julie Steenhuysen CHICAGO (Reuters) -Treating breast cancer patients with AstraZeneca's experimental pill camizestrant at the first sign of resistance to standard treatments cut the risk of disease progression or death by half, a finding that could change the way such cancers are treated, cancer experts said on Sunday. The results, presented at the American Society of Clinical Oncology meeting in Chicago, mark the first use of a blood test called a liquid biopsy to indicate the need for a change in treatment in women with a common form of breast cancer, even before tumor growth can be detected on imaging. The early switch approach in women with hormone receptor-positive, HER2-negative breast cancer resulted in a 56% reduction in the risk of disease progression or death, said Dr. Eleonora Teplinsky, an oncologist at Valley-Mount Sinai Comprehensive Cancer Care and an ASCO breast cancer expert. "When patients progress on scans, we're already behind," Teplinsky said at a media briefing. She said an early switch approach, before disease progression, allows doctors "to essentially stay ahead of the curve." Camizestrant is not yet FDA-approved, but Teplinsky believes the data will likely result in a new treatment paradigm. The trial involved 3,256 patients with advanced hormone receptor-positive, HER2-negative breast cancer, the most common type in which hormones such as estrogen fuel cancer growth. These cancers lack high levels of HER2, another cancer driver. Women in the trial had at least six months of treatment with aromatase inhibitors that block hormones fueling the cancer, as well as targeted drugs called CDK4/6 inhibitors such as Novartis' Kisqali, Pfizer's Ibrance or Lilly's Verzenio, which block an enzyme that fuels cancer growth. About 40% of patients treated with aromatase inhibitors develop mutations in the estrogen receptor 1 gene called ESR1 mutations, a sign of early drug resistance. Camizestrant and similar drugs called Selective Estrogen Receptor Degraders (SERDS) block estrogen receptor signaling in cancer cells. In the trial, researchers used blood tests to look for ESR1 mutations until 315 patients were identified. They were randomly assigned to either switch to camizestrant plus the CDK4/6 inhibitor (157 patients) or continue with standard treatment plus a placebo (158 patients). The researchers found that it took 16 months for the disease to progress in women who got camizestrant, compared with 9.2 months in those who continued on standard therapy, a statistically significant difference in progression-free survival. No new side effects were reported and few patients from either group dropped out due to side effects. "This is going to be very impactful for our patients," said Dr. Hope Rugo, head of breast medical oncology at City of Hope in Duarte, California. The question, she said, is how do doctors incorporate the testing into clinical practice. Separately, adding AstraZeneca's immunotherapy durvalumab to standard treatment before and after surgery in patients with early-stage stomach and esophageal cancers helped extend the time patients had without cancer progression or recurrence compared to chemotherapy alone. The global study of nearly 950 patients tested durvalumab, sold under the brand Imfinzi, in combination with a chemotherapy regimen called FLOT given around the time of initial cancer surgery. Patients in the durvalumab plus FLOT arm experienced a 29% better event-free survival than those who received the chemotherapy regimen. "We demonstrate that immunotherapy works in early-stage disease, which is great," lead study author Dr. Yelena Jarnigan of Memorial Sloan Kettering Cancer Center in New York told reporters at the meeting. "We did not see any new safety signals, so this will change practice for our patients, which is exciting to see." Both studies were published on Sunday in the New England Journal of Medicine.
Associated Press
31 minutes ago
- Associated Press
Kite Presents New Real-World Data Supporting Use of Potentially Curative Yescarta® in Outpatient Care Setting for Patients with Relapsed/Refractory Large B-Cell Lymphoma at ASCO 2025
SANTA MONICA, Calif.--(BUSINESS WIRE)--Jun 1, 2025-- Kite, a Gilead Company (Nasdaq: GILD), today announced real-world data evaluating the safety and effectiveness of Yescarta ® (axicabtagene ciloleucel) for patients with relapsed/refractory large B-cell lymphoma (R/R LBCL) assigned to treatment in an outpatient setting (no planned hospital stay) versus those assigned to an inpatient setting in a hospital. The analysis, based on data collected from the Center for International Blood and Marrow Transplant Research (CIBMTR) registry, observed that safety and effectiveness outcomes for people treated as outpatients were comparable to those patients who received treatment in a hospital. The results were shared in a presentation (Abstract #7023) during the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. 'The encouraging results from this study corroborate reports from treatment centers and prior studies in the real world that illustrate the potential feasibility of administering axi-cel in the outpatient setting for people with relapsed or refractory large B-cell lymphoma,' said Dr. Fateeha Furqan, lead investigator, The University of Texas MD Anderson Cancer Center. 'Outpatient administration of axi-cel has cost-effective advantages over inpatient treatment, including less burden on hospitals. These clinical results reflect the fact that the knowledge and experience needed to safely administer the therapy has only grown since axi-cel was first approved in 2017.' Data were collected from the CIBMTR observational database (between July 2021 to Nov 2023). The final analysis assessed data on patients with R/R LBCL from 75 treatment centers, comparing 119 individuals who were assigned to receive Yescarta in the outpatient setting to 119 patients assigned to receive Yescarta in the inpatient setting. With a median follow-up of 12 months, no general differences were found between the 2 groups in the rates of cytokine release syndrome, neurologic events or immune effector cell-associated neurotoxicity syndrome grade ≥ 3. Almost one-fourth of 119 patients who were assigned to receive Yescarta in the outpatient setting did not require hospital admission within 30 days, and half of 119 patients did not require hospital admission within 3 days based on propensity score-matched dataset. These real-world data are not currently in the U.S. Prescribing Information. 'We are seeing a growing body of evidence that suggests outpatient administration of Yescarta could be reliable and safe in suitable settings, with benefits for the patient, their family and healthcare system,' said Dominique Tonelli, M.D., Vice President and Global Head of Medical Affairs, Kite. 'We are confident that these promising results will help inform providers to expand the number of patients who can achieve the curative potential of a one-time treatment with Yescarta.' Patients assigned to the outpatient and inpatient treatment groups were matched by age, sex, comorbidities, lactate dehydrogenase (LDH), bulky disease, prior lines of therapy, chemosensitivity and infusion year. Patients assigned to the outpatient group had a median age of 63 years (25% ≥ 70), 66% were male and 67% had ≥ 1 comorbidity. Half had elevated LDH and 73% had 1 prior line of therapy. Bulky disease was reported in 3% and 60% had chemo-resistant disease. About LBCL Globally, LBCL is the most common type of non-Hodgkin lymphoma. In the United States, more than 18,000 people are diagnosed with LBCL each year. About 30-40% of patients with LBCL will need second-line treatment, as their cancer will either relapse (return) or become refractory (not respond) to initial treatment. About Yescarta Please see full Prescribing Information, including BOXED WARNING below and Medication Guide. YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Limitations of Use: YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma. U.S. IMPORTANT SAFETY INFORMATION BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES and SECONDARY HEMATOLOGICAL MALIGNANCIES CYTOKINE RELEASE SYNDROME (CRS) CRS, including fatal or life-threatening reactions, occurred following treatment with YESCARTA. CRS occurred in 90% (379/422) of patients with non-Hodgkin lymphoma (NHL) receiving YESCARTA, including ≥ Grade 3 (Lee grading system1) CRS in 9%. CRS occurred in 93% (256/276) of patients with large B-cell lymphoma (LBCL), including ≥ Grade 3 CRS in 9%. Among patients with LBCL who died after receiving YESCARTA, four had ongoing CRS events at the time of death. For patients with LBCL in ZUMA-1, the median time to onset of CRS was 2 days following infusion (range: 1 to 12 days) and the median duration of CRS was 7 days (range: 2 to 58 days). For patients with LBCL in ZUMA-7, the median time to onset of CRS was 3 days following infusion (range: 1 to 10 days) and the median duration was 7 days (range: 2 to 43 days). CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5, including ≥ Grade 3 CRS in 8%. Among patients with iNHL who died after receiving YESCARTA, one patient had an ongoing CRS event at the time of death. The median time to onset of CRS was 4 days (range: 1 to 20 days) and the median duration was 6 days (range: 1 to 27 days) for patients with iNHL. Key manifestations of CRS (≥ 10%) in all patients combined included fever (85%), hypotension (40%), tachycardia (32%), chills (22%), hypoxia (20%), headache (15%), and fatigue (12%). Serious events that may be associated with CRS include, cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), renal insufficiency, cardiac failure, respiratory failure, cardiac arrest, capillary leak syndrome, multi-organ failure, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) . The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in two subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events. CRS occurred in 93% (38/41), including 2% (1/41) with Grade 3 CRS; no patients experienced a Grade 4 or 5 event. The median time to onset of CRS was 2 days (range: 1 to 8 days) and the median duration of CRS was 7 days (range: 2 to 16 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Thirty-one of the 39 patients (79%) developed CRS at which point the patients were managed with tocilizumab and/or therapeutic doses of corticosteroids with no patients developing Grade 3 or higher CRS. The median time to onset of CRS was 5 days (range: 1 to 15 days) and the median duration of CRS was 4 days (range: 1 to 10 days). Although there is no known mechanistic explanation, consider the risk and benefits of prophylactic corticosteroids in the context of pre-existing comorbidities for the individual patient and the potential for the risk of Grade 4 and prolonged neurologic toxicities. Ensure that 2 doses of tocilizumab are available prior to infusion of YESCARTA. Monitor patients at least daily for 7 days at the certified healthcare facility following infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for 4 weeks after infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated. NEUROLOGIC TOXICITIES Neurologic toxicities (including immune effector cell-associated neurotoxicity syndrome) that were fatal or life- threatening occurred. Neurologic toxicities occurred in 78% (330/422) of all patients with NHL receiving YESCARTA, including ≥ Grade 3 in 25%. Neurologic toxicities occurred in 87% (94/108) of patients with LBCL in ZUMA-1, including ≥ Grade 3 in 31% and in 74% (124/168) of patients in ZUMA-7 including ≥ Grade 3 in 25%. The median time to onset was 4 days (range: 1-43 days) and the median duration was 17 days for patients with LBCL in ZUMA-1. The median time to onset for neurologic toxicity was 5 days (range:1- 133 days) and median duration was 15 days in patients with LBCL in ZUMA-7. Neurologic toxicities occurred in 77% (112/146) of patients with iNHL, including ≥ Grade 3 in 21%. The median time to onset was 6 days (range: 1-79 days) and the median duration was 16 days. Ninety-eight percent of all neurologic toxicities in patients with LBCL and 99% of all neurologic toxicities in patients with iNHL occurred within the first 8 weeks of YESCARTA infusion. Neurologic toxicities occurred within the first 7 days of infusion for 87% of affected patients with LBCL and 74% of affected patients with iNHL. The most common neurologic toxicities (≥ 10%) in all patients combined included encephalopathy (50%), headache (43%), tremor (29%), dizziness (21%), aphasia (17%), delirium (15%), and insomnia (10%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events, including aphasia, leukoencephalopathy, dysarthria, lethargy, and seizures occurred. Fatal and serious cases of cerebral edema and encephalopathy, including late-onset encephalopathy, have occurred. The impact of tocilizumab and/or corticosteroids on the incidence and severity of neurologic toxicities was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received corticosteroids at the onset of Grade 1 toxicities, neurologic toxicities occurred in 78% (32/41) and 20% (8/41) had Grade 3 neurologic toxicities; no patients experienced a Grade 4 or 5 event. The median time to onset of neurologic toxicities was 6 days (range: 1-93 days) with a median duration of 8 days (range: 1-144 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Of those patients, 85% (33/39) developed neurologic toxicities, 8% (3/39) developed Grade 3, and 5% (2/39) developed Grade 4 neurologic toxicities. The median time to onset of neurologic toxicities was 6 days (range: 1-274 days) with a median duration of 12 days (range: 1-107 days). Prophylactic corticosteroids for management of CRS and neurologic toxicities may result in higher grade of neurologic toxicities or prolongation of neurologic toxicities, delay the onset and decrease the duration of CRS. Monitor patients for signs and symptoms of neurologic toxicities at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter, and treat promptly. REMS Because of the risk of CRS and neurologic toxicities, YESCARTA is available only through a restricted program called the YESCARTA and TECARTUS REMS Program which requires that: Healthcare facilities that dispense and administer YESCARTA must be enrolled and comply with the REMS requirements and must have on-site, immediate access to a minimum of 2 doses of tocilizumab for each patient for infusion within 2 hours after YESCARTA infusion, if needed for treatment of CRS. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer YESCARTA are trained about the management of CRS and neurologic toxicities. Further information is available at or 1-844-454-KITE (5483). HYPERSENSITIVITY REACTIONS Allergic reactions, including serious hypersensitivity reactions or anaphylaxis, may occur with the infusion of YESCARTA. SERIOUS INFECTIONS Severe or life-threatening infections occurred. Infections (all grades) occurred in 45% of patients with NHL. Grade 3 or higher infections occurred in 17% of patients, including ≥ Grade 3 or higher infections with an unspecified pathogen in 12%, bacterial infections in 5%, viral infections in 3%, and fungal infections in 1%. YESCARTA should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines. Febrile neutropenia was observed in 36% of all patients with NHL and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated. In immunosuppressed patients, including those who have received YESCARTA, life-threatening and fatal opportunistic infections including disseminated fungal infections (e.g., candida sepsis and aspergillus infections) and viral reactivation (e.g., human herpes virus-6 [HHV-6] encephalitis and JC virus progressive multifocal leukoencephalopathy [PML]) have been reported. The possibility of HHV-6 encephalitis and PML should be considered in immunosuppressed patients with neurologic events and appropriate diagnostic evaluations should be performed. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells, including YESCARTA. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. PROLONGED CYTOPENIAS Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion. ≥ Grade 3 cytopenias not resolved by Day 30 following YESCARTA infusion occurred in 39% of all patients with NHL and included neutropenia (33%), thrombocytopenia (13%), and anemia (8%). Monitor blood counts after infusion. HYPOGAMMAGLOBULINEMIA B-cell aplasia and hypogammaglobulinemia can occur. Hypogammaglobulinemia was reported as an adverse reaction in 14% of all patients with NHL. Monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement. The safety of immunization with live viral vaccines during or following YESCARTA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during YESCARTA treatment, and until immune recovery following treatment. SECONDARY MALIGNANCIES Patients treated with YESCARTA may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following YESCARTA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period. ADVERSE REACTIONS The most common non-laboratory adverse reactions (incidence ≥ 20%) in patients with LBCL in ZUMA-7 included fever, CRS, fatigue, hypotension, encephalopathy, tachycardia, diarrhea, headache, musculoskeletal pain, nausea, febrile neutropenia, chills, cough, infection with unspecified pathogen, dizziness, tremor, decreased appetite, edema, hypoxia, abdominal pain, aphasia, constipation, and vomiting. The most common adverse reactions (incidence ≥ 20%) in patients with LBCL in ZUMA-1 included CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections with pathogen unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias. The most common non-laboratory adverse reactions (incidence ≥ 20%) in patients with iNHL in ZUMA-5 included fever, CRS, hypotension, encephalopathy, fatigue, headache, infections with pathogen unspecified, tachycardia, febrile neutropenia, musculoskeletal pain, nausea, tremor, chills, diarrhea, constipation, decreased appetite, cough, vomiting, hypoxia, arrhythmia, and dizziness. About Kite Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, focused on achieving cures with cell therapy. As the global cell therapy leader, Kite has treated more patients with CAR T-cell therapy than any other company. Kite has the largest in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial supply and commercial product manufacturing. For more information on Kite, please visit 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. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif. Gilead acquired Kite in 2017. 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 the ability of Gilead and Kite to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical studies, including those involving Yescarta; uncertainties relating to regulatory applications and related filing and approval timelines, including pending or potential applications for indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, 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 Kite, and Gilead and Kite assume no obligation and disclaim any intent to update any such forward-looking statements. Yescarta, Gilead, the Gilead logo, Kite, and the Kite logo are trademarks of Gilead Sciences, Inc., or its related companies. For more information on Kite, please visit the company's website Follow Kite on social media on X (@KitePharma) andLinkedIn. View source version on CONTACT: Blair Baumwell, Media [email protected] Ross, Investors [email protected] KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: RESEARCH HOSPITALS FDA CLINICAL TRIALS OTHER HEALTH BIOTECHNOLOGY PHARMACEUTICAL HEALTH SCIENCE ONCOLOGY SOURCE: Gilead Sciences, Inc. Copyright Business Wire 2025. PUB: 06/01/2025 08:00 AM/DISC: 06/01/2025 08:01 AM
San Francisco Chronicle
an hour ago
- San Francisco Chronicle
Feds' abrupt cutoff of HIV prevention funds threatens decades of progress, S.F. providers say
Leaders in HIV care in San Francisco and across the country say their critical efforts to stop new infections are under attack by a Trump administration that already has cut several key federal programs and now appears to be withholding money meant to go specifically toward prevention. The bulk of HIV prevention work is supported by federal money, including grants issued through the Centers for Disease Control and Prevention. But the CDC's HIV programs have been gutted this year, and millions in grant money that should have been in the hands of state and local health care providers by now has yet to arrive. In parts of California, including Los Angeles, some prevention programs already have been impacted because the money hasn't come through. Los Angeles County sent notices to dozens of organizations it works with that their contracts would be terminated if federal funds weren't available by June 1. San Francisco may be less immediately impacted because it does not rely on outside contractors for services, and local leaders have promised to backfill any missing federal money. The Los Angeles and San Francisco grants are for about $19 million and $7 million, respectively, and the state gets a separate allotment. But the situation is grim, said experts in HIV care, who worry that any efforts to dismantle public health and services for vulnerable communities will have disastrous effects, and could undo decades of work to slow down and eventually end the AIDS epidemic. 'We have an incredible, effective, world-class HIV prevention and care system, and we can't afford to go back because of what's happening at the federal level,' said Jonathan Frochtzwajg, director of health justice policy for the San Francisco AIDS Foundation. 'This level of uncertainty and instability is unprecedented,' Frochtzwajg said. 'In the past, funding levels may increase or decrease and we would always be in the fight. But with this administration, it's the wholesale elimination of funding streams and programs.' In San Francisco, the federal funding supports HIV prevention efforts along with programs to end other sexually transmitted diseases and hepatitis C, which are often concurrent infections. Losing that money would jeopardize the city's work toward ending the epidemic, said the San Francisco Department of Public Health, and 'significantly weaken' efforts to provide testing, offer uncomplicated access to care for those who test positive, monitor case rates and provide education and outreach. The public health department said Friday that it had not yet received the grant money, which was supposed to arrive by Sunday. HIV care leaders said they were caught off guard by President Donald Trump's attacks on their work since he took office in January. In his previous administration, the president had been supportive of efforts to end the epidemic, and had not touched federal funding. Now, those leaders say, they fear their programs have been swept up in larger plans to scale back federal government and in particular get rid of diversity, equity and inclusion programs. The CDC has especially come under attack in the second Trump administration, and several programs aimed at HIV — including the CDC's HIV research arm — have been scaled back or killed entirely. Trump also has divested from or severely curtailed involvement in programs to support HIV care internationally. HIV care requires intense public health work to control spread of disease, and efforts often are focused on vulnerable communities including people of color and transgender people, who are at much higher risk of infection than other groups. 'That's what they seem to be objecting to: 'Oh, you work with transgender people? You work with gay people? You work with Black people? '' said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute in Washington. 'We don't have the luxury of not thinking about those things,' Schmid said. 'In fact, if you want to utilize tax dollars, that's where the (HIV) cases are. That's what I call being efficient.' Ending the epidemic must include widespread, easy access to testing and prevention tools like PrEP (pre-exposure prophylaxis), say HIV experts. And those who are infected must be treated in order to keep them from passing the infection to others. Indeed, the nation's prevention programs have had a profound effect on slowing down the epidemic, which at its peak in the late 1980s and early '90s was seeing 130,000 new infections a year; that's down to about 30,000 now. In San Francisco, cases dropped from about 2,000 a year during the worst times to about 145 last year. 'Accessible HIV testing, accessible PrEP, accessible care for people living with HIV — all of that is what is driving down our new diagnoses,' said Frochtzwajg. 'We'll see that trend reverse if you take away those services.' Schmid said the timing of the federal cuts was especially frustrating because new prevention tools that will soon become available — including PrEP that may require only one injection a year to be effective — require stable foundations to get the care to people who need it. 'It's really sad, because we have such great hope on the horizon,' Schmid said. 'We have the science, and we're losing the infrastructure.' Lance Toma, chief executive of San Francisco Community Health Center, said he was concerned about the fate of organizations that reach the most vulnerable communities because they tend to be smaller and less resourced. At an event at the Commonwealth Club of San Francisco on May 21, Toma and others painted a dire outlook for HIV care, even as they said they intended to fight for resources. 'We're really headed toward a potential future where we will see the dismantling of organizations that we hold dear,' Toma said. 'Everything we've worked so hard at, the efforts we've made to make competent trans programs, or gay men of color programs — that's where I get scared. These are the folks we've worked so hard for, and these are the folks being targeted.' The Commonwealth Club event called up two panels, one focused on young activists and the other on the current climate. Several participants said they must now look to past activism — in particular, the efforts of ACT UP, a grassroots organization fighting for people with HIV and AIDS — as they pick up the battle all over again. 'We all lived through it, when it was so grim that we didn't really see any light at the end of the tunnel,' said Cecilia Chung, senior advisor with the Transgender Law Center in Oakland who is transgender and HIV positive herself. 'We persevered, we fought and we pushed through. And that's phenomenal.'
