FDA Previously Accepted the New Drug Application for Lonafarnib, an Investigational
First-in-Class Oral Therapy for Chronic Hepatitis D

KIRKLAND, Wash., Oct. 20, 2026 /PRNewswire/ — EIT Pharma, Inc. (“EIT Pharma” or the “Company”), a biotechnology company focused on developing therapies for infectious diseases, today highlighted three presentations at the 5^th Edition of the Delta Cure International Meeting in Milan, Italy. The Company presented new analyses from its lonafarnib development program for Chronic Hepatitis Delta (CHD), covering the durability of response after treatment ends, histologic improvement and the clinical significance of alanine aminotransferase (ALT) dynamics following treatment cessation.

Lonafarnib is an investigational first-in-class oral CHD therapy candidate with a unique mechanism of action. The New Drug Application for Lonafarnib for the treatment of CHD is under review by the U.S. Food and Drug Administration.

“Delta Cure has become one of the most important forums bringing together the global hepatitis D community, and we are proud to support this year’s meeting and share new analyses from the lonafarnib development program,” said Dr. Leen Kawas, Chief Executive Officer of EIT Pharma. “The findings presented at Delta Cure explore important questions regarding durability of response, liver health, and clinical outcomes following treatment and we believe continued research in these areas is essential as the hepatitis D community works toward better solutions for patients.”

Key findings from each of the presentations include:

Histologic improvement and reduction in necroinflammation with lonafarnib-based therapy in chronic hepatitis delta: phase 3 D-LIVR trial
     •     Presented by Dr. Nancy Reau
     •     Read the selected Oral poster presentation here 

Post-treatment response following 48 weeks of lonafarnib therapy: analysis of 24-week follow-up in the phase 3 D-LIVR trial in chronic hepatitis delta
     •     Presented by Dr. Saeed Hamid
     •     Read the poster here 

Clinical significance of ALT dynamics following lonafarnib treatment cessation in the phase 3 D-LIVR trial
     •     Presented by Dr. Ohad Etzion
     •     Read the poster here

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.

Media Contact

Reevemark
Jacqueline Zuhse/Jill Steinman
EITPharmaTeam@reevemark.com
212-433-4600

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SOURCE EIT Pharma