FDA Approves Gilead's Hepcludex for HDV Infection
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 22 2026
0mins
Source: seekingalpha
- First HDV Treatment: Gilead Sciences' Hepcludex (bulevirtide) has received FDA approval as the first-ever therapy for chronic hepatitis delta virus (HDV) infection, marking a significant breakthrough in liver disease treatment.
- Clinical Trial Success: The approval is based on phase 3 trial results showing that patients receiving Hepcludex had significantly better combined responses compared to those receiving delayed treatment, indicating its clinical efficacy.
- Special Drug Designations: Hepcludex has received Breakthrough Therapy and Orphan Drug designations, which not only expedited its approval process but also reflects the FDA's recognition of its potential in treating HDV infections.
- International Market Outlook: Approved in the EU in 2020 and expected to launch in Canada in 2025, Hepcludex demonstrates broad application potential in global markets, which could lead to substantial revenue growth for Gilead.
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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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- 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.
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See More
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See More
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- Alternative Treatment Options: WHO also suggests evaluating Gilead Sciences' antiviral remdesivir and its experimental drug obeldesivir for post-exposure prophylaxis, aiming to enhance treatment options and response capabilities against the outbreak.
- Vaccine Usage Restrictions: Merck's Ervebo is the only licensed Ebola vaccine; however, WHO emphasizes that it should only be used in carefully designed research settings to assess its effectiveness against Bundibugyo ebolavirus, ensuring safety and efficacy.
See More
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- Significant ALP Normalization: In the ASSURE study, 83% of participants achieved ALP normalization at 12 months, and 74% maintained this at 24 months, demonstrating Livdelzi's long-term efficacy in treating PBC patients, potentially enhancing their quality of life.
- Improvement in Liver Stiffness: An exploratory analysis showed that 85% of participants who achieved biochemical response at 12 months maintained or improved liver stiffness over three years, indicating that Livdelzi not only lowers ALP but also enhances liver health, boosting treatment confidence.
- 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.
- Clear Treatment Goals: ALP normalization is recognized as a key treatment goal in PBC, and the findings from Livdelzi's studies provide strong support for its use in PBC patients, potentially driving its wider clinical adoption.
See More
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- Innovation Center Establishment: Following the acquisition, the Tubulis team will remain in Munich to establish 'The Tubulis ADC Innovation Center,' focusing on research, manufacturing, and clinical development of antibody-drug conjugates, thereby enhancing Gilead's R&D capabilities in cancer treatment.
- Clinical Asset Integration: Tubulis' lead candidate TUB-040 is currently being evaluated for platinum-resistant ovarian and non-small cell lung cancers, and by integrating these clinical assets, Gilead aims to address significant treatment gaps for patients with challenging solid tumors.
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See More
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- Oil Prices Edge Up: International Brent crude futures added 0.9% to close at $103.54 per barrel, while West Texas Intermediate crude rose about 0.3%, reflecting market hopes for a resolution to the Iran conflict, although still below earlier peaks this week.
- New Fed Chair Sworn In: Kevin Warsh was officially sworn in as the 17th Chair of the Federal Reserve, with market expectations regarding his policy direction likely to influence future monetary policy and economic trends, especially in the context of the current economic recovery.
See More
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- FDA Accelerated Approval: Gilead Sciences' Hepcludex has received accelerated approval from the FDA, becoming the first treatment for chronic hepatitis delta virus infection in the U.S., addressing a long-standing gap in care for approximately 40,000 to 80,000 patients, which is expected to significantly enhance their quality of life.
- 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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- FDA Accelerated Approval: Gilead Sciences announced that its Hepcludex (bulevirtide-gmod) 8.5 mg has received accelerated approval from the FDA, becoming the first treatment for chronic hepatitis delta virus (HDV) infection in the U.S., addressing a significant unmet medical need.
- 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
