FDA Approves Gilead's Hepcludex for Chronic Hepatitis Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 22 2026
0mins
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.
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Analyst Views on GILD
Wall Street analysts forecast GILD stock price to rise
19 Analyst Rating
16 Buy
3 Hold
0 Sell
Strong Buy
Current: 136.220
Low
105.00
Averages
137.88
High
154.00
Current: 136.220
Low
105.00
Averages
137.88
High
154.00
About GILD
Gilead Sciences, Inc. is a biopharmaceutical company. It is engaged in advancing medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer, and inflammation. It is focused on discovering, developing, and delivering medicines to address unmet medical needs in virology, oncology, and other therapeutic areas. Its portfolio of marketed products includes AmBisome, Atripla, Biktarvy, Cayston, Complera, Descovy, Descovy for PrEP, Emtriva, Epclusa, Eviplera, Genvoya, Harvoni, Hepcludex, Hepsera, Jyseleca, Letairis, Livdelzi/Lyvdelzi, Odefsey, Sovaldi, Stribild, Sunlenca, Tecartus, Trodelvy, and others. It also sells and distributes authorized generic versions of Epclusa and Harvoni in the United States through its subsidiary, Asegua Therapeutics LLC. It has control on anitocabtagene autoleucel (anito cel), an investigational BCMA-directed CAR T cell therapy for multiple myeloma. The Company also owns an antibody-drug conjugates (ADCs) platform.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Good Safety Profile: Livdelzi showed no treatment discontinuations due to adverse events over two years of follow-up, with no new safety signals observed, indicating its good tolerability in high-risk PBC patients and supporting broader application.
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See More
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See More
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- Clinical Trial Data Support: The FDA's decision was heavily informed by data from the MYR301 multi-center Phase 3 clinical trial, which demonstrated that the percentage of participants with completely undetectable viral levels increased from 20% at week 48 to 50% by week 144, confirming the drug's efficacy over time.
- Positive Market Reaction: Following the FDA approval, Gilead's stock price surged nearly 3%, poised for its best day in about three months, reflecting strong market anticipation for the new therapy and a recovery in investor confidence, with a 29% increase in stock price over the past year.
- Global Market Presence: While newly approved in the U.S., the 2 mg dose of Hepcludex has already been available in the European Economic Area and other global markets, indicating Gilead's strategic positioning and commitment to addressing chronic liver disease treatment worldwide.
See More
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- Clinical Trial Results: In the pivotal MYR301 Phase 3 trial, Hepcludex demonstrated statistically significant improvements in HDV RNA reduction and alanine aminotransferase (ALT) normalization at Week 48 compared to the control group, indicating its efficacy.
- Patient Impact: Chronic HDV is considered the most severe form of viral hepatitis, and the FDA approval provides a new treatment option for approximately 40,000 to 80,000 HDV patients in the U.S., potentially significantly improving their quality of life and disease management.
- Future Research Commitment: Gilead has committed to conducting a confirmatory long-term outcomes study to verify the clinical benefits of Hepcludex, ensuring continued approval, which reflects the company's strong commitment to addressing this serious disease.
See More
