EIT Pharma Announces FDA Acceptance of New Drug Application for Lonafarnib for Treatment of Chronic Hepatitis D

Marks major milestone toward potential first oral treatment option for one of the most severe forms of viral hepatitis

NDA supported by Phase 3 D-LIVR study, the largest clinical trial conducted to date in Chronic Hepatitis D

KIRKLAND, Wash., Aug. 11, 2026 /PRNewswire/ -- EIT Pharma, Inc. ("EIT Pharma" or the "Company"), a biotechnology company focused on developing therapies for infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for lonafarnib for the treatment of chronic hepatitis D.

Chronic hepatitis D (CHD) is a serious, life-threatening liver disease caused by hepatitis D virus (HDV) in individuals who already have hepatitis B virus infection. CHD can progress rapidly to cirrhosis, liver failure, liver cancer, and death. Despite the seriousness of the disease, treatment options remain limited, with no current FDA-approved oral therapies for CHD in the United States.

"FDA acceptance of our NDA is an important milestone in our mission to bring a potential new oral treatment to people living with chronic hepatitis D," said Dr. Leen Kawas, PhD, Chief Executive Officer of EIT Pharma. "We're grateful to the patients, investigators, and researchers whose commitment to the D-LIVR study made this milestone possible."

Lonafarnib is an investigational first-in-class oral CHD therapy candidate with a unique mechanism of action. Lonafarnib for CHD has previously received FDA Breakthrough Therapy designation, Fast Track designation, and Orphan Drug designation. Following its acquisition of the late-stage program in 2024, EIT Pharma worked closely with regulators and scientific and medical collaborators to complete the NDA submission and is now working on preparations for commercialization. If approved, lonafarnib's oral administration, room-temperature storage, and potential for long-term event-free survival, may offer practical advantages for people impacted by CHD and healthcare providers who consider treatment burden, duration and accessibility, and long-term clinical benefit when evaluating treatment options.

The NDA is supported by data from the Phase 3 D-LIVR study, the largest clinical trial conducted to date in CHD, and Phase 1/2 clinical data, nonclinical data, and manufacturing information. The global, randomized, placebo-controlled Phase 3 D-LIVR study enrolled over 400 patients across 21 countries and evaluated lonafarnib-based regimens over 48 weeks.

"Patients living with chronic hepatitis D urgently need novel therapies that target distinct steps in the HDV lifecycle," said Dr. Jeffrey Glenn, co-founder of EIT Pharma and Joseph D. Grant Professor and Professor of Medicine and Microbiology & Immunology at Stanford University. "The FDA's acceptance of the NDA is an important first step towards getting patients with CHD a new treatment option for this serious, life-threatening disease, and we look forward to working closely with the FDA throughout the review process."

EIT Pharma will continue to work collaboratively with the FDA during its review and will continue to prepare for the commercialization of lonafarnib post-approval.

About Lonafarnib

Lonafarnib is an investigational oral therapy candidate being evaluated for the treatment of chronic hepatitis D. Lonafarnib is designed to target a key step in the hepatitis D virus lifecycle and is currently the only oral therapeutic candidate in late-stage clinical development for chronic hepatitis D. Lonafarnib has not been approved by the U.S. Food and Drug Administration or any other regulatory authority for the treatment of chronic hepatitis D. The safety and efficacy of lonafarnib have not been established.

About EIT Pharma, Inc.

EIT Pharma is a biotechnology company focused on advancing therapies for infectious diseases with significant unmet medical needs. The company is developing a portfolio of programs designed to address serious infectious diseases through rigorous science, disciplined execution, and a patient-centered approach focused on translating scientific innovation into meaningful real-world impact for patients.

Forward-Looking Statements

This press release contains forward-looking statements regarding regulatory review timelines, anticipated milestones, potential product characteristics, and future development plans. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially. Lonafarnib is an investigational product candidate and has not been approved by the FDA. There can be no assurance that the FDA will approve the NDA or that the product will become commercially available. EIT undertakes no obligation to update forward-looking statements except as required by law.

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SOURCE EIT Pharma