STOCK TITAN

Assembly Biosciences to Present Positive Phase 1a Safety, Tolerability and Target Engagement Data for ABI-6250 at AASLD The Liver Meeting® 2026

Phase 1a testing in healthy participants reported no serious adverse events at the doses evaluated.

(Neutral)

Sentiment and the balance of points

Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.

Tags

Assembly Biosciences (ASMB) will present new Phase 1a findings for ABI-6250 at AASLD’s The Liver Meeting on November 7, 2026. Two posters cover safety, tolerability and pharmacodynamic findings—how the drug affects the body—from a randomized, blinded study in healthy participants. ABI-6250 was well tolerated at the doses evaluated, with no serious adverse events reported. Dose-dependent, reversible increases in total and conjugated bile acids were consistent with engagement of NTCP, the protein targeted by ABI-6250.

Assembly plans to initiate Phase 2 studies in chronic hepatitis delta virus infection in the fourth quarter of 2026 and in cholestatic liver diseases in the first quarter of 2027, focusing on primary biliary cholangitis and primary sclerosing cholangitis. The pharmacodynamic analysis received Poster of Distinction recognition.

Loading...
Loading translation...
4 points · 0 major

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

0 major · 0 points

Hollow bars mark forward-looking points. How the balance works

Positive

  • Moderate point. Forward-looking: it has not happened yet and may not happen.Assembly plans Phase 2 initiation in chronic HDV infection in the fourth quarter of 2026.
  • Moderate point. Forward-looking: it has not happened yet and may not happen.Assembly plans Phase 2 initiation in cholestatic liver diseases in the first quarter of 2027, focusing on PBC and PSC.
  • Minor pointABI-6250 was well tolerated at the doses evaluated, with no serious adverse events in Phase 1a.
  • Minor pointDose-dependent, reversible bile acid increases were consistent with NTCP target engagement.

Negative

  • None.

Key Figures

Planned Phase 2 start: Fourth quarter 2026 Planned Phase 2 start: First quarter 2027
Planned Phase 2 start
Fourth quarter 2026
Chronic HDV infection
Planned Phase 2 start
First quarter 2027
Cholestatic liver diseases, including PBC and PSC

Historical Context

1 past event · Latest: Aug 13
1 event
  1. Aug 13

    Q2 earnings report

    24h Move
    +10.0%

    Earlier Q2 update planned ABI-6250 Phase 2 studies in chronic HDV and cholestatic diseases.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

pharmacodynamic, ntcp, psc
3 terms
pharmacodynamic medical
"ABI-6250's pharmacodynamic analysis was recognized as a Poster of Distinction"
Pharmacodynamic describes how a drug acts on the body — the biological effects it produces, how strong those effects are, and how long they last. For investors, pharmacodynamic data show whether a treatment actually works and at what dose, shaping expectations about a drug’s safety, effectiveness, regulatory success and market potential; think of it like testing how well a key turns a lock and whether it reliably opens the door.
ntcp medical
"consistent with sodium taurocholate co-transporting polypeptide (NTCP) target engagement"
NTCP is a protein on the surface of liver cells that normally helps move bile acids into the liver, and it also acts like a doorway that certain liver-targeting viruses use to enter cells. Investors watch NTCP because drugs or antibodies that block this doorway can prevent or treat viral liver diseases, which can change a drug candidate’s clinical prospects, market potential, and the valuation of companies developing those therapies.
psc medical
"focused on primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC)"
Persons with Significant Control (PSC) are the people or organizations that ultimately own or control a company—through large shareholdings, decisive voting rights, or other levers of influence—and whose identities are reported for ownership transparency. For investors, PSC information is like seeing who holds the company’s keys: it reveals who can shape strategy, influence board decisions or dividends, and signals governance risks, potential conflicts of interest, and takeover likelihood.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google

ABI-6250's pharmacodynamic analysis was recognized as a Poster of Distinction

SOUTH SAN FRANCISCO, Calif., Oct. 05, 2026 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral and liver diseases, today announced that two posters featuring new Phase 1a data from its ABI-6250 program will be presented at The Liver Meeting® 2026, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), taking place November 5-9, 2026, in Denver, Colorado.

“The Phase 1a findings support ABI-6250’s safety profile and demonstrate potent target engagement, and we are pleased the pharmacodynamic analysis was recognized as a Poster of Distinction,” said Anuj Gaggar, M.D., Ph.D., chief medical officer of Assembly Bio. “We look forward to sharing these results with the hepatology community as we prepare to advance ABI-6250 into Phase 2 studies in both chronic HDV infection and cholestatic liver diseases.”

The presentations will include safety, tolerability and pharmacodynamic findings from the randomized, blinded Phase 1a study of ABI-6250 in healthy participants. ABI-6250 was well tolerated at the doses evaluated, with no serious adverse events reported, and demonstrated dose-dependent, reversible increases in total and conjugated bile acids consistent with sodium taurocholate co-transporting polypeptide (NTCP) target engagement. The Phase 1a findings support Assembly Bio’s plans to initiate Phase 2 studies in patients with chronic hepatitis delta virus (HDV) infection in the fourth quarter of 2026 and in patients with cholestatic liver diseases, focused on primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC), in the first quarter of 2027.

Details of the presentations are as follows:

Poster of Distinction Title: Oral NTCP Inhibitor ABI-6250 Elevates Bile Acids in a Randomized, Blinded, Phase 1a Study in Healthy Subjects
Presenter: Edward J. Gane, MD, FAASLD, University of Auckland
Publication Number: 3197

  • Session: Hepatitis – Other Infections
  • Date and Time: November 7, 2026; 1:00 – 2:00 p.m. MT

Poster Title: The Safety and Tolerability of ABI-6250, an Orally Administered NTCP Inhibitor in Healthy Participants
Presenter: Edward J. Gane, MD, FAASLD, University of Auckland
Publication Number: 3204

  • Session: Hepatitis – Other Infections
  • Date and Time: November 7, 2026; 1:00 – 2:00 p.m. MT

Assembly Bio intends to make the posters 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.

About ABI-6250
ABI-6250 is an investigational oral small-molecule inhibitor of the sodium taurocholate co-transporting polypeptide (NTCP), a membrane protein selectively expressed on hepatocytes that facilitates bile acid transport into cells and also serves as the receptor for hepatitis B virus (HBV) and hepatitis delta virus (HDV) to enter hepatocytes. Assembly Bio is developing ABI-6250 for the treatment of chronic HDV infection, where the targeting of NTCP blocks viral infection and is a clinically validated mechanism. ABI-6250 is also being evaluated in cholestatic liver diseases, such as primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC), where bile acid accumulation in the liver drives liver inflammation and liver injury. The targeting of NTCP by ABI-6250 blocks the uptake of bile acids into liver cells.

About Assembly Biosciences
Assembly Biosciences is a biotechnology company developing innovative small-molecule therapeutics aimed at advancing the treatment paradigm of serious viral and liver diseases and improving the lives of patients worldwide. Led by an accomplished leadership team in antiviral and liver disease drug development, Assembly Bio is committed to improving outcomes for people living with the chronic impacts of herpesvirus, hepatitis delta virus (HDV) infections, cholestatic liver diseases and hepatitis B virus (HBV). 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, including studies conducted by Gilead, in the currently anticipated timeframes or at all; safety and efficacy data from clinical or nonclinical studies may not warrant further development of product candidates; clinical and nonclinical data may not differentiate 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:
Mike Beyer
Sam Brown LLC
(312) 961-2502 
ASMBMedia@sambrown.com


FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Assembly Biosciences’ ABI-6250 Phase 1a study show?

ABI-6250 was well tolerated at the doses evaluated, with no serious adverse events reported in the randomized, blinded study in healthy participants. Total and conjugated bile acids showed dose-dependent, reversible increases consistent with engagement of NTCP, the drug’s target protein.

When does Assembly Biosciences plan to start Phase 2 studies of ABI-6250?

Assembly plans to initiate ABI-6250 Phase 2 studies in chronic hepatitis delta virus infection in the fourth quarter of 2026 and in cholestatic liver diseases in the first quarter of 2027. The cholestatic liver disease studies will focus on primary biliary cholangitis and primary sclerosing cholangitis.

Keep reading