Assembly Biosciences to Present Topline Phase 1a Data on Hepatitis Delta Virus Entry Inhibitor ABI-6250 at the EASL Congress 2026

Rhea-AI Summary

Assembly Biosciences (Nasdaq: ASMB) will present topline Phase 1a data on ABI-6250, an investigational oral hepatitis D virus (HDV) entry inhibitor, at the EASL Congress 2026 in Barcelona on May 27, 2026.

The randomized, blinded study evaluates safety, pharmacokinetics and pharmacodynamic activity in healthy participants.

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SOUTH SAN FRANCISCO, Calif., May 13, 2026 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today announced topline clinical data on ABI-6250, an investigational oral hepatitis D virus (HDV) entry inhibitor, will be presented in a poster presentation at the European Association for the Study of the Liver (EASL) Congress taking place May 27-30, 2026, in Barcelona, Spain.

“We are pleased to present additional Phase 1a data on ABI-6250 at EASL,” said Anuj Gaggar, MD, PhD, chief medical officer of Assembly Bio. “As the only oral entry inhibitor currently in clinical development for chronic hepatitis D, ABI-6250 is designed to offer a differentiated approach, and these data further support our plan to advance directly into a Phase 2 study by year-end.”

The presentation will feature results from a randomized, blinded, Phase 1a study evaluating the safety, pharmacokinetics and pharmacodynamic activity of ABI-6250 following single- and multiple-dose administration in healthy participants.

Presentation details are as follows:

Title: Safety, Pharmacokinetics, and Pharmacodynamic Activity of ABI-6250, a First-in-Class Oral Hepatitis D Virus Entry Inhibitor, in Healthy Subjects: Interim Results From a Randomized, Blinded, Phase 1a Study
Presenter: Edward J. Gane, MD, University of Auckland
Poster Number: WED-579
Session: Viral Hepatitis B and D: New therapies, unapproved therapies or strategies
Date: Wednesday, May 27, 2026

Assembly Bio intends to make the poster available on the “Events & Presentations” page in the “Investors” section and on the “Publications” page in the “Pipeline” section of its website at www.assemblybio.com.

ABI-6250 is an investigational product candidate that has not been approved anywhere globally, and its safety and efficacy has not been established.

About Assembly Biosciences
Assembly Biosciences is a biotechnology company dedicated to the development of innovative small-molecule therapeutics designed to change the path of serious viral diseases and improve the lives of patients worldwide. Led by an accomplished team of leaders in virologic drug development, Assembly Bio is committed to improving outcomes for patients struggling with the serious, chronic impacts of herpesvirus, hepatitis B virus (HBV) and HDV infections. For more information, visit assemblybio.com.

Forward-Looking Statements
The information in this press release contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to materially differ. These risks and uncertainties include: Assembly Bio’s ability to realize the potential benefits of its collaboration with Gilead, including all financial aspects of the collaboration and equity investments; Assembly Bio’s ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio’s collaboration with Gilead, in the currently anticipated timeframes or at all; safety and efficacy data from clinical or nonclinical studies may not warrant further development of Assembly Bio’s product candidates; clinical and nonclinical data may not differentiate Assembly Bio’s product candidates from other companies’ candidates; Assembly Bio’s ability to maintain financial resources and secure additional funding necessary to continue its research activities, clinical studies, and other business operations; potential effects of changes in government regulation; results of nonclinical studies may not be representative of disease behavior in a clinical setting and may not be predictive of the outcomes of clinical studies; and other risks identified from time to time in Assembly Bio’s reports filed with the U.S. Securities and Exchange Commission (the SEC). You are urged to consider statements that include the words may, will, would, could, should, might, believes, hopes, estimates, projects, potential, expects, plans, anticipates, intends, continues, forecast, designed, goal or the negative of those words or other comparable words to be uncertain and forward-looking. Assembly Bio intends such forward-looking statements to be covered by the safe harbor provisions contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. More information about Assembly Bio’s risks and uncertainties are more fully detailed under the heading “Risk Factors” in Assembly Bio’s filings with the SEC, including its most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Except as required by law, Assembly Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:

Investors:
Patrick Till
Meru Advisors
(484) 788-8560
investor_relations@assemblybio.com

Media:
Sam Brown LLC
Jamie Strachota
(703) 819-7647
ASMBMedia@sambrown.com

FAQ

What is ABI-6250 in development by Assembly Biosciences (ASMB) for hepatitis D?

ABI-6250 is an investigational oral hepatitis D virus entry inhibitor being developed by Assembly Biosciences. According to the company, it is designed to block HDV entry into cells and is being evaluated for safety, pharmacokinetics and pharmacodynamic activity in early-stage studies.

When and where will Assembly Biosciences (ASMB) present ABI-6250 Phase 1a data?

Assembly Biosciences plans to present topline Phase 1a data on ABI-6250 at the EASL Congress 2026. The congress takes place May 27-30, 2026, in Barcelona, Spain, with the ABI-6250 poster scheduled for Wednesday, May 27, 2026.

What does the Phase 1a study of ABI-6250 by Assembly Biosciences (ASMB) evaluate?

The Phase 1a study of ABI-6250 evaluates safety, pharmacokinetics and pharmacodynamic activity in healthy participants. According to Assembly Biosciences, the trial includes single- and multiple-dose administration in a randomized, blinded design to generate early clinical data on this HDV entry inhibitor.

How does Assembly Biosciences describe ABI-6250’s position among hepatitis D treatments?

Assembly Biosciences describes ABI-6250 as the only oral entry inhibitor currently in clinical development for chronic hepatitis D. The company views it as a differentiated approach targeting HDV entry, with plans to advance directly into a Phase 2 study by year-end.

Where can investors find the ABI-6250 EASL 2026 poster for Assembly Biosciences (ASMB)?

Assembly Biosciences intends to post the ABI-6250 EASL 2026 poster on its website. According to the company, it will appear under the “Events & Presentations” section of the Investors area and the “Publications” page within the Pipeline section.

Has ABI-6250 from Assembly Biosciences (ASMB) been approved for use in patients?

ABI-6250 has not been approved for use anywhere globally and remains an investigational product candidate. According to Assembly Biosciences, the safety and efficacy of ABI-6250 have not been established, and current data come from early-stage clinical evaluation in healthy participants.