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Intellectia

GILD News

New Findings on Livdelzi in PBC Treatment

2d agoNewsfilter

WHO Approves Evaluation of Regeneron's Antibody for Ebola Treatment

1d agoseekingalpha

Gilead Acquires Tubulis for $3.15B to Enhance Oncology Portfolio

4d agoYahoo Finance

U.S. Stocks Rise as Hopes for Iran Peace Deal Increase

May 22 2026stocktwits

Gilead Secures Accelerated Approval for Hepcludex

May 22 2026stocktwits

Gilead Receives FDA Approval for Chronic HDV Treatment

May 22 2026Newsfilter

FDA Approves Gilead's Hepcludex for HDV Infection

May 22 2026seekingalpha

WHO Raises Ebola Outbreak Risk Level in DRC to Very High

May 22 2026Newsfilter

GILD Events

05/27 05:30
Gilead's Livdelzi Shows Significant ALP Reduction in PBC Patients
Gilead shared new results from a post hoc analysis showing that Livdelzi was associated with high and sustained rates of normalization of a key liver marker in people living with primary biliary cholangitis. In an ongoing Phase 3 study, participants with elevated ALP levels experienced reductions in ALP after treatment. These data highlight the potential role of Livdelzi in people with PBC who continue to have elevated ALP despite prior treatment with first-line therapy. 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. The data will be presented at the European Association for the Study of the Liver Congress 2026, held May 27-30 in Barcelona, Spain. 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 1.67ULN. Among 50 participants, 83% of evaluable participants achieved composite ALP normalization-defined as ALP of 1ULN 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, 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% of participants who achieved biochemical response at 12 months and were followed up through three years maintained or improved liver stiffness measurements. Liver stiffness stability is a commonly used non-invasive marker associated with long-term outcomes and is descriptive in nature in this open-label analysis.
05/22 16:20
Dow Hits Record High, S&P 500 Posts Eighth Week of Gains
Stocks closed higher on Friday amid strong earnings and cautious signs of progress toward ending the U.S. conflict with Iran. The Dow advanced to a record high, while the S&P 500 and the Nasdaq 100 posted their eighth week of gains ahead of the long holiday weekend.Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:Estee Lauderand Puigannounced that the parties haveregarding a potential business combinationImaxis exploring a sale, according toWorkdayreportedand reiterated its FY27 revenue guidanceZoom Communicationsprovided areport for Q1Deckers Outdoorreportedand provided its outlook for FY272. WALL STREET CALLS:JPMorganSweetgreenon ramping brand transformationViking Holdingsto Buy at Truist on strong demand trendsJefferiesGeneracon data center contract potentialSummit Therapeuticsto Neutral at H.C. WainwrightInspire Medicalto Underperform at BofA on coding overhang3. AROUND THE WEB:Nintendoaims to make about 20M Switch 2 consoles in the year through March, Bloomberg reportsMicrosoftagreed to pay $250M to settle investor litigation over its massive takeover Activision Blizzard, Bloomberg saysSony'sBungie plans to lay off a significant number of workers as it concludes active development on "Destiny 2," Bloomberg saysStarbucksshut down an AI program for automating inventory counts, nine months after deploying it, after it frequently miscounted and mislabeled items, Reuters saysSamsungis set to distribute about $26.6B to its 78,000 chip employees, or a $340,000 bonus to each, in early 2027 as part of a last-minute labor union deal, Bloomberg reports4. MOVERS:Pelotongained afterEnviriin the S&P 600Rocket Labsincreased after completing its ninthGileadwas higher after the FDA approved the company'sFutu Holdingsand UP Fintechfell in New York afterhas launched a broad crackdown on unauthorized cross-border investingImmunityBiodeclined after reportingand presenting preliminary results from a new health economic analysis on that ANKTIVA plus Bacillus Calmette-Guerin5. EARNINGS/GUIDANCE:BJ's Wholesaleand backed its guidance for FY26 after what CEO Bob Eddy called "a strong first quarter"Take-Two, with EPS missing consensusBooz Allenand provided guidance for FY27Ross Stores, with EPS and revenue beating consensusGlobal Ship Lease, with EPS lower year-over-yearINDEXES:The Dow rose 294.04, or 0.58%, to 50,579.70, the Nasdaq gained 50.87, or 0.19%, to 26,343.97, and the S&P 500 advanced 27.75, or 0.37%, to 7,473.47.
05/22 13:30
FDA Approves Gilead's Hepcludex for Chronic Hepatitis Treatment
The U.S. Food and Drug Administration approved Hepcludex injection to treat chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis. Bulevirtide is the first FDA-approved treatment for chronic HDV infection, a serious and life-threatening condition that can cause rapid development of liver fibrosis, liver cancer, liver failure, and even death. "Today's approval fills a critical gap in care for patients with chronic HDV infection, who until now have had no FDA-approved therapies available," said Wendy Carter, D.O., Acting Director of the Office of Infectious Diseases in FDA's Center for Drug Evaluation and Research. "For individuals living with this chronic viral infection, this new treatment option offers hope in managing a disease that can rapidly progress to serious liver complications." The FDA granted the approval to Gilead Sciences, Inc.

GILD Monitor News

Gilead Sciences Faces Pressure Amid Market Decline

Mar 20 2026

Gilead's Yescarta Label Update Approved by FDA

Feb 11 2026

Gilead's Trodelvy and Keytruda Combo Shows 35% Death Risk Reduction

Jan 23 2026

Gilead Sciences reaches 20-day high amid market gains

Jan 21 2026

Gilead Sciences hits 20-day low amid market strength

Jan 05 2026

GILD Earnings Analysis

Gilead Sciences Q1 2025 Earnings: Growth Amid Challenges- Intellectia AI™
1 years ago
Gilead Sciences Q4 2024 Financial Performance Review - Intellectia AI™
1 years ago

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