Cyclosporine

Data show rapid initiation with once-monthly SUBLOCADE significantly improves retention in opioid use disorder (OUD) patients, especially among fentanyl-positive participants. Study also administered second SUBLOCADE injection a week later vs. standard 28 days, enabling patients to achieve and maintain target medication levels more quickly. Data show rapid initiation with once-monthly SUBLOCADE significantly improves retention in opioid use disorder (OUD) patients, especially among fentanyl-positive participants. Study also administered second SUBLOCADE injection a week later vs. standard 28 days, enabling patients to achieve and maintain target medication levels more quickly. Presented at the 2024 Canadian Society of Addiction Medicine (CSAM) conference, this study highlights the potential of rapid initiation to transform the treatment of opioid use disorder. Presented at the 2024 Canadian Society of Addiction Medicine (CSAM) conference, this study highlights the potential of rapid initiation to transform the treatment of opioid use disorder. Data supporting the subcutaneous administration of SUBLOCADE to alternative injection sites including the thigh, upper arm, and buttocks vs current subcutaneous abdominal injection site, were also presented at CSAM. Data supporting the subcutaneous administration of SUBLOCADE to alternative injection sites including the thigh, upper arm, and buttocks vs current subcutaneous abdominal injection site, were also presented at CSAM. SUBLOCADE has received Priority Review designation from the U.S. Food and Drug Administration (FDA) to expand the label to include rapid initiation one hour after a single transmucosal buprenorphine dose as well as inclusion of alternative injection sites. SUBLOCADE has received Priority Review designation from the U.S. Food and Drug Administration (FDA) to expand the label to include rapid initiation one hour after a single transmucosal buprenorphine dose as well as inclusion of alternative injection sites. RICHMOND, Va., Nov. 19, 2024 -- Indivior PLC (Nasdaq/LSE: INDV) last week shared results from a randomized, open-label sub-study in opioid-dependent participants seeking treatment, (NCT04995029) that demonstrates rapid initiation (RI) with SUBLOCADE® (buprenorphine extended-release injection) for the treatment of OUD significantly improves treatment retention compared to standard initiation (SI). RI with SUBLOCADE in a single day may reduce barriers to treatment and improve patient retention especially those who frequently inject opioids or use fentanyl without increasing the risk of precipitated opioid withdrawal (POW) symptoms. The data were presented at the 2024 Canadian Society of Addiction Medicine (CSAM) conference in Hamilton, Ontario, Canada. “These findings underscore the potential for rapid initiation to transform opioid use disorder treatment,” said Dr. Christian Heidbreder, Ph.D., Chief Scientific Officer at Indivior. “Rapid initiation may improve patient retention and meet the immediate needs brought on by synthetic opioids in real-world settings, offering a practicable path to stabilization and long-lasting, meaningful recovery.” Conducted across multiple sites, this non-inferiority study included 729 participants (mean age 42, average opioid use of 15 years), stratified by fentanyl presence in urine screens, with an observed 78% fentanyl-positive rate. Patients randomized to RI received a single dose of 4 mg transmucosal buprenorphine (TM-BUP), followed by a SUBLOCADE injection within 1 hour. The primary endpoint was treatment retention at injection 2, administered 1 week after injection 1 comparing it to the current standard regimen of 28 days. Those in the SI group received daily TM-BUP doses over ≥7 days before injection, and if non-inferiority was met, superiority was assessed. Among the participants, RI was superior to SI in retention rates at injection 2, with a 12% improvement overall and 15% in the fentanyl-positive group. The shorter dose interval between BUP-XR injection 1 and 2 was designed to achieve and maintain buprenorphine plasma concentrations more quickly at target levels of 2 ng/mL. The overall Treatment Emergent Adverse Events (TEAE) profile up to Injection 2 was comparable for RI and SI. There were no unexpected safety findings. Data supporting the subcutaneous administration of SUBLOCADE to alternative injection sites including the thigh, upper arm, and buttocks were also presented at CSAM (NCT04995029). SUBLOCADE has received Priority Review designation granted by the U.S. Food and Drug Administration (FDA) for a labeling supplement, which would expand the label to include rapid initiation one hour after a single transmucosal buprenorphine dose and also expands from the current subcutaneous abdominal injection site for induction and maintenance to alternative injection sites including the thigh, upper arm, and buttocks. With a Prescription Drug User Fee Act (PDUFA) action date set for February 7, 2025, this Prior Approval Supplement (PAS) submission, if approved, could allow healthcare providers a flexible approach to initiate treatment rapidly, supporting better retention outcomes for OUD patients, particularly those testing positive for fentanyl. A Priority Review designation means that the FDA's goal is to take action on an application within 6 months (compared to 10 months under standard review). If approved, this label change could translate into significant improvements in OUD treatment with SUBLOCADE. +++ This press release has been issued by Indivior Inc. and the content has not been approved or authorized by the Canadian Society of Addiction Medicine. +++ About SUBLOCADE® SUBLOCADE ® (buprenorphine extended-release) injection, for subcutaneous use, CIII INDICATION AND HIGHLIGHTED SAFETY INFORMATION INDICATION SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days. SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support. HIGHLIGHTED SAFETY INFORMATION WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION; SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY Serious harm or death could result if administered intravenously. SUBLOCADE forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including life threatening pulmonary emboli, if administered intravenously. Serious harm or death could result if administered intravenously. SUBLOCADE forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including life threatening pulmonary emboli, if administered intravenously. Because of the risk of serious harm or death that could result from intravenous self-administration, SUBLOCADE is only available through a restricted program called the SUBLOCADE REMS Program. Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in this program and comply with the REMS requirements. Because of the risk of serious harm or death that could result from intravenous self-administration, SUBLOCADE is only available through a restricted program called the SUBLOCADE REMS Program. Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in this program and comply with the REMS requirements. CONTRAINDICATIONS SUBLOCADE should not be administered to patients who have been shown to be hypersensitive to buprenorphine or any component of Indivior's proprietary buprenorphine gel depot delivery system. WARNINGS AND PRECAUTIONS Addiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors. Respiratory Depression: Life threatening respiratory depression and death have occurred in association with buprenorphine. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with SUBLOCADE. Opioids can cause sleep-related breathing disorders e.g., central sleep apnea (CSA), sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. Consider decreasing the opioid using best practices for opioid taper if CSA occurs. Strongly consider prescribing naloxone at SUBLOCADE initiation or renewal because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose. Educate patients and caregivers on how to recognize respiratory depression and how to treat with naloxone if prescribed. Risk of Serious Injection Site Reactions: The most common injection site reactions are pain, erythema and pruritus with some involving abscess, ulceration, and necrosis. The likelihood of serious injection site reactions may increase with inadvertent intramuscular or intradermal administration. Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome is an expected and treatable outcome of prolonged use of opioids during pregnancy. Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off the opioid. Risk of Opioid Withdrawal With Abrupt Discontinuation: If treatment with SUBLOCADE is discontinued, monitor patients for several months for withdrawal and treat appropriately. Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to and during treatment. Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patient is clinically stable on transmucosal buprenorphine before injecting SUBLOCADE. Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect. ADVERSE REACTIONS Adverse reactions commonly associated with SUBLOCADE (in ≥5% of subjects) were constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzymes, fatigue, and injection site pain. For more information about SUBLOCADE, the full Prescribing information including BOXED WARNING, and Medication Guide, visit www.sublocade.com. About Opioid Use Disorder (OUD) Opioid Use Disorder (OUD) is a chronic disease in which people develop a pattern of using opioids that can lead to negative consequences.1 OUD may affect the parts of the brain that are necessary for life-sustaining functions.1,2 Important Cautionary Note Regarding Forward-Looking Statements This press release contains certain statements that are forward-looking. Forward-looking statements include, among other things, express and implied statements regarding: Indivior PLC’s expectations regarding the timing of approval for the PAS for rapid induction and injection sites, and the potential impact on OUD treatments and Sublocade from such; and other statements containing the words "believe," "anticipate," "plan," "expect," "expectations," "intend," "estimate," "forecast," “strategy,” “target,” “guidance,” “outlook,” “potential,” "project," "priority," "may," "will," "should," "would," "could," "can," the negatives thereof, and variations thereon and similar expressions. By their nature, forward-looking statements involve risks and uncertainties as they relate to events or circumstances that may or may not occur in the future. Actual results may differ materially from those expressed or implied in these forward-looking statements due to a number of factors, including: failure or delay in obtaining approval of the PAS and the acceptance by HCPs and their patients of the perceived benefits of such PAS changes. For information about some of the risks and important factors that could affect our future results and financial condition, see "Risk Factors" in Indivior's Annual Report on Form 20-F for the fiscal year 2023 and its other filings with the U.S. Securities and Exchange Commission. We have based the forward-looking statements in this press release on our current expectations and beliefs concerning future events. Forward-looking statements contained in this press release apply only at the date of this press release and, except as required by law, we undertake no obligation to update or revise any forward-looking statement, whether due to new information, future developments, or otherwise. About Indivior Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD). Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior. Media Contacts: US Media: Cassie France-Kelly VP, Communications Indivior PLC Tel: +1(804) 724-0327 References  National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Committee on Medication-Assisted Treatment for Opioid Use Disorder, Mancher, M., & Leshner, A. I. (Eds.). (2019). Medications for Opioid Use Disorder Save Lives. National Academies Press (US). Accessed October 30, 2023, from https://www.ncbi.nlm.nih.gov/books/NBK538936/pdf/Bookshelf_NBK538936.pdf NIDA. 2022, March 22. Drugs and the Brain. Accessed October 30,2023, from https://nida.nih.gov/publications/drugs-brains-behavior-science-addiction/drugs-brain

FOSTER CITY, Calif.--( BUSINESS WIRE )--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. ASSURE ( NCT03301506 ) is an ongoing, open-label, study evaluating the long-term efficacy and safety of Livdelzi. ASSURE is enrolling adults with PBC who previously participated in a study of Livdelzi where a key eligibility criterion includes having an inadequate response or intolerance to ursodeoxycholic acid (UDCA). Using a data cutoff of January 31, 2024, the interim analysis represented all participants in the ASSURE study, including those who participated in prior clinical studies of Livdelzi (legacy studies) and participants from the pivotal Phase 3 RESPONSE study. Results demonstrate the safety profile of Livdelzi remains robust, with no treatment-related serious adverse events (SAEs) reported throughout the study duration. The exposure-adjusted incidence of adverse events decreased over time, with 86, 70, and 63 participants per 100 patient-years observed in years 1, 2 and 3 of treatment, respectively. Livdelzi continues to appear generally well tolerated, with no new safety signals or change in frequency of adverse events (AEs) with up to three years of exposure. These results are consistent with the results presented at the European Association for the Study of the Liver (EASL) Congress earlier this year. “ These data support what we’ve already observed with seladelpar. The long-term data from the ASSURE study reinforce that seladelpar consistently lowers ALP, offering a promising and much-needed option for patients living with this chronic liver condition,” said Eric J. Lawitz, MD, principal investigator and Medical Director of the Texas Liver Institute and a Clinical Professor of Medicine at University of Texas Health San Antonio, Texas, USA. “ ALP levels are recognized as an important surrogate marker of disease progression in PBC, and providers are shifting to view ALP normalization as a treatment goal. ALP levels are critical markers in assessing liver health, and for people with PBC who are not adequately responding to first-line therapies, reducing, or even normalizing these levels, can make a significant difference in the management of this disease.” In addition to the ASSURE data, Gilead showcased findings from two oral presentations highlighting additional analyses from the Phase 3 RESPONSE trial ( NCT04620733 ): A prespecified subgroup analysis underscored the efficacy and safety profile of Livdelzi in people living with PBC and compensated cirrhosis. At Month 12, the adjusted mean change from baseline in ALP for participants with cirrhosis on Livdelzi was -121.4 U/L (a decrease of approximately 35% from baseline) versus 23.2 U/L (an increase of approximately 6.6%) on placebo, and -134.8 U/L (a decrease of approximately 43.5%) for Livdelzi versus -18.0 U/L (a decrease of approximately 5.8%) for placebo in participants without cirrhosis. In Livdelzi participants, AEs were reported in 89% and 86% of participants with and without cirrhosis, respectively, versus 89% and 84% in placebo participants. A secondary analysis of pruritus in RESPONSE showed that among participants with a numerical rating score (NRS) of ≥4 and NRS ≥7 at baseline, Livdelzi led to near resolution (NRS of 0 or 1) of itch at Month 12 in 26.5% and 18.8% of participants, respectively, versus 0% of participants on placebo. In Livdelzi participants, AEs were reported in 87.8% and 86.1% of participants with baseline NRS ≥4 and NRS <4, respectively, versus 91.3% and 81% in placebo participants. Overall, the proportion of participants with AEs was similar for Livdelzi and placebo regardless of baseline itch severity. “ Gilead has a legacy of bringing groundbreaking treatments to people in need and Livdelzi is the first and only treatment to demonstrate statistically significant and durable improvements in both pruritus and markers of cholestasis related to the risk of disease progression,” said Timothy Watkins, MD, MSc, Vice President, Clinical Development, Inflammation Therapeutics, Gilead Sciences. “ With Livdelzi, we’ve introduced an effective and well tolerated option for people living with PBC, offering an important novel treatment option. We remain committed to advancing innovative therapies that provide real hope and improved outcomes for people facing this challenging liver disease.” In a separate analysis, which spans the Livdelzi program in PBC, Gilead highlighted findings from a large safety database of people treated with Livdelzi for up to five years, which demonstrated that Livdelzi was generally well tolerated considering cumulative use across studies. A total of 486 participants received Livdelzi 10 mg and 152 participants received placebo. The exposure-adjusted subject incidence (per 100 patient-years) for Livdelzi was 48.3 for AEs, 8.0 for SAEs, and 6.1 for liver-related AEs, as compared to 132 for AEs (rate reflective of shorter exposure time for placebo participants), 7.8 for SAEs, and 13.3 for liver-related AEs in placebo participants. There were no treatment-related SAEs. For more information on the AASLD Annual Meeting and Gilead’s presentations, please visit the AASLD website . Please see below for U.S. Indication and Important Safety Information for Livdelzi. About ASSURE (NCT03301506) ASSURE is an open label study to evaluate the long-term safety and tolerability of seladelpar in people with primary biliary cholangitis (PBC) who have already participated in other PBC clinical trials of seladelpar. The study is currently enrolling up to 500 people living with PBC from across 160 sites around the world. Participants enrolled in ASSURE at the time of this interim data analysis include participants from previous studies of seladelpar in PBC, including the Phase 3 registrational RESPONSE study and legacy clinical trials. Legacy studies include the open label Phase 2 dose-ranging study (2 mg, 5 mg, or 10 mg seladelpar), the open label Phase 3/4 long-term safety study (5 mg or 10 mg seladelpar), the Phase 3 placebo-controlled ENHANCE study (5 mg or 10 mg seladelpar vs placebo), and the ongoing open label study in people with PBC and hepatic impairment. ENHANCE and the long-term study were both terminated early. About RESPONSE (NCT04620733) RESPONSE is the pivotal Phase 3, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of seladelpar in adults with primary biliary cholangitis (PBC) who have shown inadequate response or intolerance to ursodeoxycholic acid (UDCA). The trial enrolled 193 participants across multiple sites worldwide. RESPONSE assessed the key biomarker of cholestasis alkaline phosphatase (ALP) and other parameters of liver function, as well as secondary endpoints including pruritus and other patient quality of life measurements. Participants in the RESPONSE trial received a daily oral dose of 10 mg of seladelpar for 12 months. The trial also aims to address the high unmet need for effective second-line therapies for individuals with PBC. About Livdelzi Livdelzi ® (seladelpar) is an oral PPAR-delta agonist, or delpar, for the treatment of primary biliary cholangitis (PBC). PPAR-delta has been shown to regulate critical metabolic and liver disease pathways. Preclinical and clinical data indicate Livdelzi has anticholestatic, anti-inflammatory, antipruritic, and antifibrotic effects. Livdelzi has potential to help meet the current unmet need of people living with PBC, as the first and only treatment that achieved statistically significant reduction across biochemical response, alkaline phosphatase (ALP) normalization, and pruritus versus placebo. Pruritus is a common symptom that can significantly impair quality of life in people with PBC. Livdelzi (10 mg capsule) was granted accelerated approval for the treatment of PBC by the U.S. Food and Drug Administration (FDA) in August 2024. Livdelzi received FDA Breakthrough Therapy Designation, as well as Orphan Drug Designation for the treatment of people living with PBC. Seladelpar has also been accepted for review by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA). As part of the FDA accelerated approval, Gilead has committed to a confirmatory long-term outcomes study called AFFIRM, which has already been initiated in people with compensated cirrhosis. Continued approval may be contingent upon verification of clinical benefit in confirmatory trial(s). The Gilead Support Path ® Program offers information and resources to help patients who are prescribed Livdelzi understand coverage and financial options. U.S. Indication for Livdelzi Livdelzi is indicated 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. This indication is approved under accelerated approval based on a reduction of ALP. Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Limitations of Use: Use of Livdelzi is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy). U.S. Important Safety Information for Livdelzi Warnings and Precautions Fractures: Fractures occurred in 4% of LIVDELZI-treated patients compared to no placebo-treated patients. Consider the risk of fracture in the care of patients treated with LIVDELZI and monitor bone health according to current standards of care. Liver Test Abnormalities: LIVDELZI has been associated with dose-related increases in serum transaminase (AST and ALT) levels > 3 x ULN in patients receiving 50 mg and 200 mg once daily (5x and 20x higher than the recommended dosage of 10 mg once daily). Perform baseline clinical and laboratory testing when starting LIVDELZI and monitor thereafter according to routine patient management. Interrupt treatment if the liver tests (ALT, AST, total bilirubin, and/or ALP) worsen, or if the patient develops signs and symptoms of clinical hepatitis (eg, jaundice, right upper quadrant pain, eosinophilia). Consider permanent discontinuation if liver tests worsen after restarting LIVDELZI. Biliary Obstruction: Avoid use of LIVDELZI in patients with complete biliary obstruction. If biliary obstruction is suspected, interrupt LIVDELZI and treat as clinically indicated. Adverse Reactions The most common adverse reactions (≥5%) with LIVDELZI were headache (8%), abdominal pain (7%), nausea (6%), abdominal distension (6%), and dizziness (5%). Drug Interactions OAT3 Inhibitors and Strong CYP2C9 Inhibitors: Avoid coadministration with LIVDELZI due to increased LIVDELZI exposure. Rifampin: Monitor biochemical response (e.g., ALP and bilirubin) when patients initiate rifampin during LIVDELZI treatment. Coadministration may result in delayed or suboptimal biochemical response of LIVDELZI. Dual Moderate CYP2C9 and Moderate-to-Strong CYP3A4 Inhibitors and BCRP Inhibitors (eg, cyclosporine): Monitor closely for adverse effects. Concomitant administration with LIVDELZI may increase LIVDELZI exposure. CYP2C9 Poor Metabolizers Using Moderate-to-Strong CYP3A4 Inhibitors: Monitor more frequently for adverse reactions as concomitant use of a moderate-to-strong CYP3A4 inhibitor in patients who are CYP2C9 poor metabolizers may increase LIVDELZI exposure and risk of LIVDELZI adverse reactions. Bile Acid Sequestrants: Administer LIVDELZI at least 4 hours before or 4 hours after taking a bile acid sequestrant, or at as great an interval as possible. Pregnancy and Lactation Pregnancy: There are insufficient data from human pregnancies exposed to LIVDELZI to allow an assessment of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Report pregnancies to Gilead Sciences, Inc., at 1-800-445-3235. Lactation: There are no data on the presence of LIVDELZI in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for LIVDELZI and any potential adverse effects on the breastfed infant from LIVDELZI. About PBC PBC is a rare, chronic inflammatory liver disease primarily affecting women (1 in 1,000 women over the age of 40 or about 130,000 total people in the U.S.). PBC is characterized by impaired bile flow (known as cholestasis) and the accumulation of toxic bile acids in the liver, leading to inflammation and destruction of the bile ducts within the liver and causing increased levels of alkaline phosphatase (ALP), alanine transaminase (ALT) and gamma-glutamyl transferase (GGT), enzymes found primarily in the liver, as well as total bilirubin. The most common symptoms of PBC are pruritus and fatigue, which can be debilitating for some people. Progression of PBC is associated with an increased risk of liver-related mortality. About Gilead Sciences in Liver Disease For decades, Gilead has pioneered the way forward to improve the lives of people living with liver disease around the world. We have helped to transform hepatitis C from a chronic condition into one that can be cured for millions of people. For people living with hepatitis B or D, our focus on advancing our medicines drives hope that today’s research will turn into tomorrow’s cures. Beyond viral hepatitis, we’re working to deliver advanced treatments for people living with PBC. But our commitment doesn’t stop there. Through our ground-breaking science and collaborative partnerships, we strive to create healthier futures for everyone living with liver disease. We are committed to a future without liver disease. 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, California. 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 within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving Livdelzi (seladelpar) (such as the RESPONSE, ENHANCE, ASSURE and any confirmatory studies); uncertainties relating to regulatory applications and related filing and approval timelines, including MHRA and EMA reviews of seladelpar for the treatment of PBC; 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; 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 September 30, 2024, 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. Livdelzi, Support Path, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. U.S. full Prescribing Information for Livdelzi 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).