Tillkännagivande • May 29

Gilead Sciences Shares Interim Phase 3 ASSURE Data Demonstrating High And Sustained ALP Normalization With Livdelzi (Seladelpar) In People With Primary Biliary Cholangitis

Gilead Sciences, Inc. shared new results from a post hoc analysis showing that Livdelzi (seladelpar) was associated with high and sustained rates of normalization of a key liver marker (ALP) in people living with primary biliary cholangitis (PBC). In an ongoing Phase 3 study, participants with elevated ALP levels (between 1.0 and 1.67×ULN) experienced reductions in ALP after treatment. These findings are highly relevant for people living with PBC with inadequately controlled disease based on elevated ALP levels—a population historically underrepresented in randomized clinical trials. ASSURE is an ongoing, open-label Phase 3 study evaluating the long-term safety and efficacy of Livdelzi in people living with PBC who previously participated in Livdelzi clinical trials. In an interim post hoc analysis, a high and sustained reduction in ALP was observed with Livdelzi treatment in participants with elevated baseline ALP levels between 1.0 and 1.67×ULN. Among 50 participants, 83% of evaluable participants achieved composite ALP normalization—defined as ALP =1×ULN with =15% reduction—at 12 months, and 74% achieved the same endpoint at 24 months, demonstrating a persistent response over two years of treatment. Mean ALP levels declined substantially from baseline and remained reduced through long-term follow-up. Improvements were also observed in other markers of cholestasis, including gamma-glutamyl transferase (GGT), and total bilirubin remained stable overall. This population included individuals with recognized risk factors for disease progression, including cirrhosis and younger age at diagnosis. Livdelzi was found to be generally well tolerated, with no treatment discontinuations due to adverse events with up to two years of follow-up and no new safety signals observed, consistent with previously reported findings. Separately, in an exploratory analysis across the full ASSURE population, 85% (n=77/91) of participants who achieved biochemical response at 12 months and were followed up through 3 years maintained or improved liver stiffness measurements. Additional interim analyses from the ASSURE and pivotal RESPONSE studies help support the long-term efficacy and safety profile of Livdelzi across a broad range of people living with PBC. Livdelzi (seladelpar) is approved for use 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 in the United States (U.S.), United Kingdom (UK), Australia and Israel, as well as the European Economic Area (EEA), Switzerland and Canada where it is marketed as Lyvdelzi. ASSURE is an open-label, long-term study to evaluate the safety and tolerability of Livdelzi in people with primary biliary cholangitis (PBC) who have already participated in other PBC clinical trials of Livdelzi. The ASSURE study includes participants from previous studies of Livdelzi 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 Livdelzi), the open label Phase 3/4 long-term safety study (5 mg or 10 mg Livdelzi), the Phase 3 placebo-controlled ENHANCE study (5 mg or 10 mg Livdelzi vs placebo), and the PBC and hepatic impairment study for Livdelzi. RESPONSE was a pivotal Phase 3, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of Livdelzi in adults with primary biliary cholangitis (PBC) who have shown inadequate response or intolerance to ursodeoxycholic acid (UDCA) defined by an ALP >= 1.67x ULN. 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 Livdelzi for 12 months. The trial aimed to address the high unmet need for effective second-line therapies for individuals with PBC. The approvals of Livdelzi were based primarily on data from the RESPONSE study. PBC is a chronic, autoimmune disease of the bile ducts that affects approximately 130,000 Americans. PBC is more common in women and causes liver damage that can progress to liver failure and result in the need for liver transplant, if left untreated. The most common symptoms of PBC are pruritus (chronic itch) and fatigue, which many people living with PBC can experience and may profoundly compromise quality of life. There is currently no cure for PBC, and treatment goals include reducing the risk of disease progression and reducing symptoms related to cholestasis (impaired bile flow), such as cholestatic itch. Treatment effect is primarily assessed through liver biochemical tests, including improvements in alkaline phosphatase (ALP), an important marker of disease activity associated with long-term outcomes in PBC. Livdelzi (seladelpar) is an oral PPAR-delta agonist, or delpar, for the treatment of primary biliary cholangitis (PBC). PPAR-delta is known to regulate key metabolic and liver disease pathways. Preclinical and clinical data indicate that Livdelzi has anticholestatic, anti-inflammatory, antipruritic, and antifibrotic effects. Clinical trial data demonstrate that Livdelzi improves key markers associated with disease activity, including biochemical response and alkaline phosphatase (ALP) normalization, with sustained effects observed over long-term follow-up. These findings are supported by clinical studies evaluating Livdelzi in hundreds of participants treated for up to five years. Livdelzi addresses ongoing unmet needs for people living with PBC, including those who remain inadequately controlled on existing therapies. Pruritus is a common symptom of PBC that can significantly impair quality of life, and prior studies have shown statistically significant and clinically meaningful improvements in pruritus with Livdelzi compared with placebo. 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. The FDA approved this indication under accelerated approval based on a reduction of alkaline phosphatase (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). Use of Livdelzi is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).

Total avkastning till aktieägarna	3.0%
Framtida utdelningsavkastning	2.2%
Utdelningstillväxt	6.4%
Nästa utbetalningsdag för utdelning	07 Oct 26
Ex utdelningsdag	15 Sep 26
Utdelning per aktie	n/a
Utdelningsandel	-123%

Segment	Utdelningsavkastning
Företag (GILD)	2.4%
Marknadens lägsta 25% (CA)	1.5%
Marknad Topp 25% (CA)	5.6%
Genomsnitt för branschen (Biotechs)	1.9%
Prognosanalytiker (GILD) (upp till 3 år)	2.2%

Uppgifter	Senast uppdaterad (UTC-tid)
Analys av företag	2026/08/17 12:07
Aktiekurs vid dagens slut	2026/08/17 00:00
Intäkter	2026/06/30
Årlig intjäning	2025/12/31

Paket	Uppgifter	Tidsram	Exempel US-källa
Företagets finansiella ställning	10 år	Resultaträkning Kassaflödesanalys Balansräkning	SEC Form 10-K SEC Form 10-Q
Analytikernas konsensusuppskattningar	+3 år	Prognos för finansiella poster Analytikernas prismål	Rapporter från analytiker Blue Matrix
Marknadspriser	30 år	Aktiekurser Utdelningar, splittar och åtgärder	ICE Marknadsdata SEC Form S-1
Ägarskap	10 år	Största aktieägare Insiderhandel	SEC Formulär 4 SEC Formulär 13D
Förvaltning	10 år	Ledningsgrupp Styrelse och verkställande direktörer	SEC Form 10-K SEC Form DEF 14A
Viktiga utvecklingstendenser	10 år	Företagsmeddelanden	SEC Formulär 8-K

Analytiker	Institution
David Toung	Argus Research Company
Brian Skorney	Baird
James Birchenough	Barclays

Gilead Sciences Utdelningar och återköp

Utdelning kriterier kontrolleras 4/6

Viktig information

Senaste utdelnings- och återköpsuppdateringar

Gilead Sciences, Inc. announces Quarterly dividend, payable on December 30, 2025

Gilead Sciences, Inc. (NasdaqGS:GILD) announces an Equity Buyback for $6,000 million worth of its shares.

Recent updates

Gilead: Buy The Distortion Before Q2 Clears It Up

Gilead Sciences, Inc. Recommends Trodelvy Plus Keytruda In PD-(L)1-Positive First-Line Metastatic Triple-Negative Breast Cancer

Gilead Sciences, Inc. to Report Q2, 2026 Results on Aug 04, 2026

Gilead Sciences, Inc.(NasdaqGS:GILD) dropped from Russell 1000 Dynamic Index

Gilead Sciences, Inc. Announces FDA Approval Of Trodelvy for First-Line Treatment Of Metastatic Triple-Negative Breast Cancer

Gilead Sciences Announces European Commission Approval for Trodelvy as First-Line Treatment for Metastatic Triple-Negative Breast Cancer

Gilead Sciences Receives Fda Acceptance for Supplemental New Drug Application for Once-Weekly Oral Yeztugo for Hiv Prevention

Gilead Sciences, Inc. And Merck Announce Positive Topline Results From Two Phase 3 Studies Evaluating Islatravir/Lenacapavir, An Oral Once-Weekly HIV Treatment

Gilead Sciences, Inc. (NasdaqGS:GILD) completed the acquisition of Ouro Medicines, Inc. from Keymed Biosciences Inc. (SEHK:2162) and others.

Gilead Sciences Announces Statistically Significant Composite ALP Normalization With Livdelzi In Phase 3 IDEAL Trial In Primary Biliary Cholangitis

Gilead Sciences Shares Interim Phase 3 ASSURE Data Demonstrating High And Sustained ALP Normalization With Livdelzi (Seladelpar) In People With Primary Biliary Cholangitis

Gilead Sciences, Inc. Receives U.S. FDA Priority Review For Once-Daily HIV Treatment Bictegravir Plus Lenacapavir

Gilead Sciences, Inc. (NasdaqGS:GILD) completed the acquisition of 77.2% stake in Arcellx, Inc. (NasdaqGS:ACLX) from New Enterprise Associates, Inc., Sr One Capital Fund I Aggregator, LP, fund managed by SR One Capital Management, LP, and others.

Gilead Sciences, Inc. to Report Q1, 2026 Results on May 07, 2026

Gilead Sciences, Inc. (NasdaqGS:GILD) entered into a definitive agreement to acquire Tubulis GmbH from a group of shareholders for $5 billion.

Gilead Sciences, Inc. (NasdaqGS:GILD) entered into a definitive agreement to acquire Ouro Medicines, Inc. from Keymed Biosciences Inc. (SEHK:2162) and others for $2.2 billion.

Gilead Sciences, Inc., Annual General Meeting, Apr 30, 2026

Gilead Sciences, Inc. Announces the Presentation of New Phase 3 ARTISTRY-1 and ARTISTRY-2 Trial Data At CROI 2026

Gilead Sciences, Inc. to Present New Hiv Treatment and Prevention Data At Croi 2026, with A Focus on Expanding Options

Gilead Sciences, Inc. Provides Earnings Guidance for the Full Year 2026

Fda Approves Label Update for Kite's Yescarta®? for Relapsed/Refractory Primary Central Nervous System Lymphoma

Gilead Sciences, Inc. to Report Q4, 2025 Results on Feb 10, 2026

Gilead Sciences, Inc. Announces New England Journal of Medicine Publishes Phase 3 ASCENT-04/KeyNOTE-D19 Results Supporting Trodelvy®? Plus Keytruda®? as a Potential New Standard of Care in First-line PD-L1+ Metastatic Triple-Negative Breast Cancer

Gilead Sciences, Inc. Appoints Keeley Wettan as Executive Vice President, General Counsel, Legal & Compliance Effective December 18, 2025

Gilead Sciences, Inc. Announces Positive Topline Results from the Phase 3 ARTISTRY-2 Trial

Deborah H. Telman to No Longer Serve as Executive Vice President, Corporate Affairs and General Counsel of Gilead Sciences, Inc. as of December 5, 2025

Gilead Sciences, Inc. Joins Partners for Delivery of First Shipments of Breakthrough Twice-Yearly Lenacapavir for HIV Prevention to Sub-Saharan Africa

Gilead Sciences, Inc.'s Investigational Single-Tablet Regimen of Bictegravir and Lenacapavir for HIV-1 Treatment Meets Primary Endpoint in Phase 3 ART-1 Trial

Gilead Sciences, Inc. Provides Update on Phase 3 ASCENT-07 Study

Gilead Sciences, Inc. announces Quarterly dividend, payable on December 30, 2025

Gilead Sciences, Inc. Revises Earnings Guidance for the Year 2025

Gilead Sciences, Inc. to Showcase Interim Long-Term Efficacy Data for Livdelzi (Seladelpar) in Primary Biliary Cholangitis (Pbc) and Investigational Bulevirtide in Chronic Hepatitis Delta

Gilead Sciences, Inc. Receives Health Canada Approval for the Treatment of Primary Biliary Cholangitis

Gilead Sciences, Inc. to Spotlight New Virology Data Across HIV, Viral Hepatitis and Respiratory Diseases at IDWeek 2025

Gilead Presents New Hiv Research Data At EACS 2025 – Driving Scientific Innovation in Treatment and Prevention

Gilead and Kite Reinforce Bold Commitment to Transform Cancer Care with New Data At Esmo 2025

Gilead Sciences, Inc. to Report Q3, 2025 Results on Oct 30, 2025

Gilead Sciences, Inc. Announces European Commission Authorizes Twice-Y Early Yeytuo (Lenacapavir) for HIV Prevention

Gilead Sciences, Inc. (NasdaqGS:GILD) announces an Equity Buyback for $6,000 million worth of its shares.

Gilead Receives Positive CHMP Opinions Under Accelerated Review from European Medicines Agency for Twice-Yearly HIV PrEP Option in the European Union

Gilead Presents New Data on Twice-Yearly Lenacapavir (Yeztugo®) for Hiv Prevention At Ias 2025

Gilead Sciences, Inc. Announces U.S. Food and Drug Administration Approves Yeztugo (Lanacapavir) as Pre-Exposure Prophylaxis

Gilead Sciences, Inc. Announces Trodelvy Plus Keytruda®? Reduces Risk of Disease Progression or Death by 35% Versus Keytruda and Chemotherapy in First-Line PD-L1+ Metastatic Triple-Negative Breast Cancer

Gilead Sciences, Inc. Announces Positive Topline Results from the Phase 3 ASCENT-03 Study of Trodelvy

Gilead's Livdelzi (Seladelpar) Demonstrated Consistent Efficacy and Safety Regardless of Prior Treatment History in New Data Presented At EASL 2025

Kommande utbetalning av utdelning

Stabilitet och tillväxt i betalningar

Utdelningsavkastning jämfört med marknaden

Vinstutdelning till aktieägarna

Kontantutbetalning till aktieägarna

Upptäck bolag med stark utdelning

Företagsanalys och finansiella data Status

Datakällor

Analysmodell och snöflinga

Industri- och sektormått

Källor för analytiker