Released positive Phase 1b interim results for long-acting helicase-primase inhibitor candidate ABI-5366 showing significant reductions in viral shedding rate and genital lesion rate in recurrent genital herpes Announced Phase 1a interim results for orally bioavailable HDV entry inhibitor candidate ABI-6250 supporting progression into Phase 2 evaluation Additional interim Phase 1b data readouts from HSV program anticipated... Read More

Phase 1b data demonstrating favorable safety and tolerability profile and potent reductions in viral nucleic acids highlighted in late-breaking poster presentation SOUTH SAN FRANCISCO, Calif., Nov. 07, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today announced Phase 1b clinical data for its next-generation... Read More

SOUTH SAN FRANCISCO, Calif., Oct. 14, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today announced that the company will participate in fireside chats at two upcoming investor conferences. H.C. Wainwright Liver Disease Virtual Conference Anuj Gaggar, MD, PhD, chief medical officer, will present in a... Read More

Late-breaking oral presentation highlights interim Phase 1b data reported earlier this year for two cohorts in participants with recurrent genital herpes Statistically significant reductions in HSV-2 shedding rate, high viral load shedding rate and genital lesion rate observed in the cohort evaluating 350 mg weekly oral dose compared to placebo Interim data evaluating a monthly dosing regimen of ABI-5366 and weekly dosing... Read More

SOUTH SAN FRANCISCO, Calif., Aug. 08, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (“Assembly Bio”) (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today announced the pricing of an underwritten, registered offering (the “offering”) of an aggregate of 5,591,840 shares of common stock and pre-funded warrants to purchase up to 1,040,820 shares of common stock,... Read More

94% reduction in HSV-2 shedding rate and 98% reduction in high viral load shedding rate, both statistically significant, observed in cohort evaluating 350 mg weekly oral dose compared to placebo over 29-day evaluation period 94% reduction in genital lesion rate, also statistically significant, observed with 350 mg weekly oral dose compared to placebo over same period Favorable safety and tolerability profile observed in the... Read More

Data to date in single- and multiple-ascending dose cohorts of healthy participants demonstrate a four-day half-life for ABI-6250, supporting target daily oral dosing profile and dose-dependent elevations in biomarker of target engagement Further pharmacological assessment to be conducted in parallel with Phase 2 preparation SOUTH SAN FRANCISCO, Calif., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq:... Read More

On track for proof-of-concept Phase 1b data no later than this fall in participants with recurrent genital herpes for long-acting herpes simplex virus (HSV) helicase-primase inhibitor candidates, ABI-5366 and ABI-1179 Positive topline data reported for Phase 1b study of ABI-4334, a next-generation highly potent capsid assembly modulator candidate, in participants with chronic hepatitis B virus (HBV) Interim data, including a... Read More

Phase 1a clinical data in healthy participants presented for both ABI-5366 and ABI-1179, novel long-acting herpes simplex virus helicase-primase inhibitor candidates Preclinical data and U.S. genital herpes prevalence and treatment patterns also highlighted Interim proof-of-concept Phase 1b data in participants with recurrent genital herpes expected for both candidates in fall 2025 SOUTH SAN FRANCISCO, Calif., July 26, 2025... Read More

Study will evaluate safety and antiviral activity of ABI-1179 in participants with recurrent genital herpes ABI-1179 IND cleared to support study expansion to sites in United States Phase 1b studies for ABI-1179 and ABI-5366 running concurrently with interim data for both candidates on track for fall 2025 SOUTH SAN FRANCISCO, Calif., June 30, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology... Read More

Favorable safety and tolerability profile, as well as pharmacokinetics supporting once-daily oral dosing, continued to be observed in final 400 mg cohort Mean plasma HBV DNA reductions of 3.2 logs IU/mL over 28 days of treatment for 400 mg cohort consistent with findings in 150 mg cohort, supporting ability of 150 mg dose to achieve saturated inhibition of viral replication, as anticipated Trial completion triggers opt-in... Read More

SOUTH SAN FRANCISCO, Calif., May 27, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today announced that Jason Okazaki, chief executive officer and president, and Anuj Gaggar, MD, PhD, chief medical officer, will present in a fireside chat during the Jefferies 2025 Global Healthcare Conference at 8:45 a.m.... Read More

Ongoing clinical studies for four candidates on track with data expected in 2025, including interim Phase 1b data for long-acting helicase-primase inhibitors ABI-5366 and ABI-1179 anticipated in fall 2025 New data from multiple programs highlighted at ICAR, ESCMID and EASL 2025 SOUTH SAN FRANCISCO, Calif., May 08, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing... Read More

– Late-breaker poster highlights preclinical profile of ABI-6250, currently in Phase 1a with data anticipated in Q3 2025 – – Second poster describes in vitro studies of effects on viral infection markers by ABI-4334, currently in Phase 1b with data anticipated in the first half of 2025 – SOUTH SAN FRANCISCO, Calif., May 07, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing... Read More

Clinical and preclinical data supporting dosing profile and tolerability for ABI-5366, a novel long-acting helicase-primase inhibitor candidate, featured in two poster presentations Additional poster presentation highlights new insights in genital herpes prevalence and treatment patterns in the U.S. ABI-5366 is currently being evaluated in ongoing Phase 1b clinical trial with interim proof-of-concept data expected in fall... Read More

Four development candidates in clinical studies with data anticipated this year, continuing rapid progress of antiviral pipeline Interim Phase 1b proof-of-concept data, including initial efficacy measures, anticipated in fall 2025 for ABI-5366 and ABI-1179, long-acting helicase-primase inhibitor candidates for recurrent genital herpes SOUTH SAN FRANCISCO, Calif., March 20, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc.... Read More

Phase 1a study will evaluate single and multiple ascending doses of ABI-6250 in healthy participants with data expected in Q3 2025 Biomarker of ABI-6250 target engagement, serum bile acids, will be assessed in addition to safety and pharmacokinetic measures SOUTH SAN FRANCISCO, Calif., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics... Read More

ABI-1179 was well-tolerated, with a half-life of approximately four days and high exposure across the dose range evaluated supporting the potential for once-weekly oral administration at a low dose Assembly Bio to move ABI-1179 directly into Phase 1b portion of the ongoing Phase 1a/b study in participants with recurrent genital herpes Phase 1b to run concurrently with ongoing Phase 1b study for ABI-5366, with interim data... Read More

ABI-4334 was well-tolerated with a favorable safety profile and half-life supporting once-daily oral dosing observed In the first 150 mg dose cohort, ABI-4334 showed strong antiviral activity with a mean reduction of 2.9 log IU/mL in plasma HBV DNA over 28 days of treatment Enrollment in final cohort of 400 mg ongoing with data anticipated in 1H 2025 SOUTH SAN FRANCISCO, Calif., Dec. 26, 2024 (GLOBE NEWSWIRE) -- Assembly... Read More

Assembly Bio to receive approximately $20.1 million equity investment and $10 million in accelerated funding under the collaboration, extending cash runway to mid-2026 Additional equity investment raises Gilead’s ownership stake in Assembly Bio to 29.9% Funding supports pipeline progress, including amendment to accelerate clinical development of Assembly Bio’s novel small molecule hepatitis D virus candidate ABI-6250 SOUTH... Read More

Positive Phase 1a interim data released for ABI-5366, a long-acting HSV helicase-primase inhibitor candidate for recurrent genital herpes, supporting potential for once-weekly and once-monthly oral dosing First participants dosed in Phase 1b trial evaluating ABI-5366 in individuals with recurrent genital herpes with interim data expected in first half of 2025 Phase 1b trial for ABI-4334, a next-generation highly potent... Read More

ABI-5366 was well-tolerated, with a favorable safety profile observed with exposure of up to 70 days Half-life of approximately 20 days supports once-weekly or once-monthly oral dosing; both dosing schedules will be explored in the Phase 1b portion of the study Screening of participants with recurrent genital herpes is now underway for Phase 1b SOUTH SAN FRANCISCO, Calif., Sept. 23, 2024 (GLOBE NEWSWIRE) -- Assembly... Read More

Dosing initiated in healthy participants in Phase 1a/b trial for ABI-5366 targeting recurrent genital herpes, with interim Phase 1a first-in-human data expected in Q3 2024 and interim Phase 1b data in participants with recurrent genital herpes expected in first half of 2025 Dosing initiated in Phase 1b trial for ABI-4334 in participants with chronic HBV infection, with interim Phase 1b data expected by end of year Two... Read More

Data from both ABI-5366 and ABI-1179, novel long-acting helicase-primase inhibitor candidates for recurrent genital herpes, to be presented Poster presentation highlights key preclinical data from ABI-5366 supporting its entry into ongoing Phase 1a/b clinical trials Oral and poster presentations feature first data presented from ABI-1179, expected to enter the clinic by the end of 2024 SOUTH SAN FRANCISCO, Calif., July 15,... Read More

SOUTH SAN FRANCISCO, Calif., June 18, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today announced that the first participant has been dosed in the Phase 1b trial of ABI-4334, a next-generation capsid assembly modulator (CAM) candidate in development for the treatment of chronic hepatitis B virus (HBV)... Read More

Funding supports advancement of antiviral portfolio, including four candidates in clinical development, and extends cash runway into Q1 2026 Anticipated near term interim data read outs include ABI-5366 Phase 1a in 3Q24 and Phase 1b in 1H25, and ABI-4334 Phase 1b by end of 2024 SOUTH SAN FRANCISCO, Calif., June 17, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (“Assembly Bio”) (Nasdaq: ASMB), a biotechnology company... Read More

Phase 1a study portion of single ascending dosing in healthy participants will inform the development of ABI-5366 with interim data expected in Q3 2024 Phase 1b study portion of multiple ascending weekly doses in participants with recurrent genital herpes on track to initiate by end of year with interim data expected in 1H 2025 SOUTH SAN FRANCISCO, Calif., June 10, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq:... Read More

Poster highlights promising preclinical profile of ABI-6250 ahead of entry into the clinic, expected by end of 2024 SOUTH SAN FRANCISCO, Calif., June 05, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today announced new data for ABI-6250, the company’s orally bioavailable, small molecule hepatitis D virus (HDV)... Read More

Preclinical data from both ABI-5366 and ABI-1179, Assembly Bio’s long-acting helicase-primase inhibitor candidates targeting recurrent genital herpes, featured in poster and oral presentations at the International Herpesvirus Workshop Poster accepted for presentation at EASL Congress™ 2024 highlights preclinical profile of ABI-6250, a novel, small molecule orally-bioavailable entry inhibitor candidate for hepatitis D SOUTH... Read More

Clinical trial application clearances received for a Phase 1a/1b trial for ABI-5366 targeting recurrent genital herpes, and a Phase 1b trial for ABI-4334 in chronic HBV infection; both studies on track to initiate by mid-2024 ABI-5366 interim Phase 1a first-in-human data expected in Q3 2024 and ABI-4334 interim Phase 1b data expected by end of year SOUTH SAN FRANCISCO, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- Assembly... Read More

Four candidates planned to be in clinical development in 2024 with interim data from two studies anticipated by year end Clinical development timelines accelerated for ABI-5366; now anticipating interim data from Phase 1a available in 3Q2024, initiation of Phase 1b in individuals with recurrent genital herpes by end of 2024 and interim Phase 1b data available in 1H2025 Gilead Sciences, Inc. partnership supports advancement... Read More

Assembly Bio common stock expected to begin trading on a split-adjusted basis on February 12, 2024 SOUTH SAN FRANCISCO, Calif., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today announced that it expects a 1-for-12 reverse stock split of its outstanding shares of common stock will be... Read More

Four development candidates anticipated to be in the clinic by the end of 2024, reflecting expansion of R&D portfolio across herpesviruses and hepatitis B and D viruses Initial clinical data anticipated by end of year from first-in-human study of long-acting helicase-primase inhibitor targeting recurrent genital herpes (ABI-5366) and Phase 1b study of next-generation core inhibitor for chronic hepatitis B virus (ABI-4334)... Read More

SOUTH SAN FRANCISCO, Calif., Nov. 10, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today announced a grant of inducement awards to its chief medical officer, Anuj Gaggar, MD, PhD on November 8, 2023. The Company granted Dr. Gaggar non-qualified stock options to purchase 500,000 shares of the Company’s... Read More

Poster highlights potential of oral small molecule IFNAR agonist program to engage the IFNα pathway through a liver-focused approach to improve tolerability SOUTH SAN FRANCISCO, Calif., Nov. 10, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today announced new data from its virology portfolio featured... Read More

Established partnership with Gilead Sciences to advance differentiated treatments for herpesviruses, HBV, HDV and beyond Now anticipate four development candidates from expanded pipeline in clinical development by the end of 2024 Named Anuj Gaggar, MD, PhD, as chief medical officer $100 million upfront payment and investment received from Gilead in October extends projected cash runway into 2H 2025 SOUTH SAN FRANCISCO,... Read More

Dr. Gaggar is an experienced industry executive with substantial infectious disease expertise and proven record of successfully leading early- and clinical-stage antiviral programs SOUTH SAN FRANCISCO, Calif., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today announced that Anuj Gaggar, MD,... Read More

One poster and one oral presentation selected, with the poster highlighting new preclinical data from the Company’s interferon-α receptor agonist program SOUTH SAN FRANCISCO, Oct. 11, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today announced that preclinical and clinical data from its virology... Read More

ABI-6250 demonstrated low nanomolar potency against hepatitis D virus and selective inhibition of NTCP in preclinical studies with once-daily dosing projected Progression into clinical studies planned by the end of 2024 SOUTH SAN FRANCISCO, Calif., Oct. 02, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases,... Read More

Two oral presentations and one poster will feature new data from the Company’s hepatitis B/hepatitis D entry inhibitor, capsid assembly modulator ABI-4334, and interferon-alpha receptor agonist programs SOUTH SAN FRANCISCO, Calif., Sept. 19, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today announced... Read More

Herpesvirus candidate ABI-5366 anticipated to enter clinic in first half of 2024 New data for several pipeline programs presented at IHW and EASL 2023 Additional development candidate nomination expected in 2023 SOUTH SAN FRANCISCO, Calif., Aug. 09, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today... Read More

First presentation of preclinical data describing the activity, pharmacokinetics and safety profile of ABI-5366, supporting planned clinical entry in 1H 2024 SOUTH SAN FRANCISCO, Calif., July 17, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today announced data from development candidate ABI-5366, a... Read More

SOUTH SAN FRANCISCO, Calif., June 21, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc . (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today announced data from its hepatitis D virus (HDV) and hepatitis B virus (HBV) antiviral pipeline featured in five poster presentations at the International Liver Congress™, the Annual Meeting of the European... Read More

International Herpesvirus Workshop will feature oral and poster presentations of preclinical data from ABI-5366, Assembly Bio’s first herpesvirus development candidate Five posters accepted for presentation at EASL 2023 highlight the latest data from pipeline in hepatitis B and hepatitis D viruses SOUTH SAN FRANCISCO, Calif., June 07, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company... Read More

SOUTH SAN FRANCISCO, Calif., May 23, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today announced that Jason Okazaki, chief executive officer and president, and William Delaney, PhD, chief scientific officer, will present in a fireside chat during the 2023 Jefferies Healthcare Conference at 4:00 p.m.... Read More

Herpesvirus candidate ABI-5366 progressing towards IND and planned to enter the clinic in the first half of 2024 Additional development candidate nomination anticipated in 2023 Multiple abstracts accepted for presentation at EASL 2023 in June SOUTH SAN FRANCISCO, Calif., May 04, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting... Read More

Phase 1a clinical data for remaining 200 mg multiple dose cohort for ABI-4334 continue to demonstrate encouraging clinical profile with strong projected activity against both viral replication and cccDNA formation Assembly Bio will evaluate partnering options for its core inhibitor portfolio prior to further clinical development of the mechanism for HBV cure The company will prioritize resources on its promising portfolio of... Read More

Prioritization of core inhibitor candidate ABI-4334 and pausing of core inhibitor candidate ABI-H3733 based on data to date from ongoing clinical Phase 1 studies of both candidates and chronic toxicology observation for ABI-H3733 Phase 1a complete clinical data for all ABI-4334 dose cohorts expected in April 2023 Advancing expanded research portfolio, with additional development candidate nomination anticipated in 2023 and... Read More

ABI-5366 Demonstrates Favorable Profile for a Long-Acting Therapeutic in Preclinical Studies IND-Enabling Studies Initiating for 5366, Supporting Anticipated IND/CTA Filing in 1H2024 SOUTH SAN FRANCISCO, Calif., Feb. 15, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today announced the... Read More

In initial ABI-H3733 cohort of 50 mg in 28-day Phase 1b study, six of eight HBV patients on treatment reached lower limit of quantification for HBV DNA by day 21 and patients showed a mean reduction of 3.1 logs in plasma HBV DNA Initial ABI-4334 Phase 1a single-dose 30 mg cohort demonstrated pharmacokinetic profile supportive of once-daily oral dosing and provides early indication that ABI-4334's very high potency seen... Read More