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ASSEMBLY BIOSCIENCES, INC. (ASMB)

Assembly Biosciences, Inc. is a biotechnology firm in the clinical development phase, dedicated to identifying and advancing innovative therapeutic solutions for hepatitis B virus (HBV) infections within the United States. Its primary drug candidate, Vebicorvir, has successfully concluded Phase 2 clinical trials for individuals with chronic HBV. The company's development pipeline also features ABI-H3733, which has finished Phase 1a clinical studies, and ABI-4334, currently in pre-clinical assessment for HBV treatment. Assembly Biosciences has forged collaborative partnerships, including agreements with BeiGene, Ltd. and Arbutus Biopharma Corporation, as well as with Antios Therapeutics, Inc., to explore a triple-combination treatment strategy for chronic hepatitis B virus. Additionally, it maintains strategic licensing arrangements with Indiana University Research and Technology Corporation and Door Pharmaceuticals, LLC. Established in 2005, the company was formerly known as Ventrus Biosciences, Inc. before rebranding to Assembly Biosciences, Inc. in June 2014, and its headquarters are located in South San Francisco, California.

Sector: Pharmaceutical Preparations

Industry: Biotechnology

Assembly Biosciences, Inc. logo

Assembly Biosciences, Inc.

NASDAQ:ASMBHealthcare
-3.50%$20.13
AH$20.13+0.00%vs close
Mkt Cap$409.86M
Float10.4M
O/S20.36M
Vol
$ Vol
RVOL
Inst Own67.6%
Earnings
Dilution
Upcoming Catalysts
  • ABI-6250READOUT
    Cash runway at this date: > 5 yr
    Fourth quarter of 2027~60w8-K
Phase Distribution
30 lead-sponsored trials·0 active·18 completed
Phase 118
Phase 1/21
Phase 29
Phase 32

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Status
Phase
  • Phase 3
    Terminated

    Efficacy and Safety Study to Treat Subjects With Symptomatic Internal Hemorrhoids

    Iferanserin, Placebo

    Internal Hemorrhoids

    Enrollment
    403
    Start
    Jul 2011
    Primary Completion
    Jun 2012
    Completion
    Jun 2012
    NCT01355874
  • Phase 3
    Completed

    Efficacy and Safety Study With Diltiazem Hydrochloride Cream to Treat Anal Fissures

    VEN 307, Placebo

    Chronic Anal Fissures

    Enrollment
    434
    Start
    Oct 2012
    Primary Completion
    Dec 2013
    Completion
    Jan 2014
    NCT01690221
  • Phase 2
    Completed

    Efficacy Study of Iferanserin to Treat Hemorrhoids

    Iferanserin, Placebo

    Hemorrhoids

    Enrollment
    121
    Start
    Sep 2001
    Primary Completion
    Aug 2002
    Completion
    Aug 2002
    NCT01483833
  • Phase 2
    Completed

    A Study Evaluating ABI-H0731 as Adjunctive Therapy in Participants With Chronic Hepatitis B Infection

    ABI-H0731, SOC NUC

    Chronic Hepatitis B

    Enrollment
    73
    Start
    Jun 2018
    Primary Completion
    Jul 2019
    Completion
    Jul 2019
    NCT03576066
  • Phase 2
    Completed

    A Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Participants With Chronic Hepatitis B Virus Infection (cHBV)

    ABI-H0731, SOC ETV

    Chronic Hepatitis B

    Enrollment
    25
    Start
    Jun 2018
    Primary Completion
    Jun 2019
    Completion
    Jun 2019
    NCT03577171
  • Phase 2
    Terminated

    A Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients

    standard of care (SOC) Nucleoside reverse transcriptase inhibitor (NrtI)

    Chronic Hepatitis B

    Enrollment
    92
    Start
    Dec 2018
    Primary Completion
    Apr 2021
    Completion
    Apr 2021
    NCT03780543
  • Phase 2
    Terminated

    A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection

    ABI-H2158, Placebo

    Chronic Hepatitis B

    Enrollment
    88
    Start
    Aug 2020
    Primary Completion
    Oct 2021
    Completion
    Dec 2021
    NCT04398134
  • Phase 2
    Terminated

    A Study Evaluating Treatment Intensification With ABI-H0731 in Participants With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors

    ABI-H0731, Placebo

    Chronic Hepatitis B

    Enrollment
    2
    Start
    Nov 2020
    Primary Completion
    Apr 2021
    Completion
    Apr 2021
    NCT04454567
  • Phase 2
    Terminated

    A Study Evaluating ABI-H0731-containing Regimens in Chinese Participants With Chronic Hepatitis B Virus Infection

    ABI-H0731, ETV

    Chronic Hepatitis B

    Enrollment
    54
    Start
    Feb 2021
    Primary Completion
    Dec 2022
    Completion
    Dec 2022
    NCT04781647
  • Phase 2
    Terminated

    A Study Evaluating Treatment Regimens Containing Vebicorvir (ABI-H0731) in Participants With Chronic Hepatitis B Infection

    VBR, AB-729

    Chronic Hepatitis B

    Enrollment
    65
    Start
    May 2021
    Primary Completion
    Mar 2023
    Completion
    Mar 2023
    NCT04820686
  • Phase 2
    Not yet recruiting

    A Study to Assess the Safety, Pharmacokinetics, and Efficacy of ABI-6250 in Participants With Chronic Hepatitis D Virus Infection

    ABI-6250, ABI-6250

    Chronic Hepatitis D Infection

    Enrollment
    80
    Start
    Oct 2026est.
    Primary Completion
    Jun 2027est.READOUT
    Completion
    Sep 2028est.
    NCT07762027
  • Phase 1/2
    Completed

    Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B

    ABI-H0731, Placebo for ABI-H0731

    Chronic Hepatitis B

    Enrollment
    38
    Start
    Jun 2017
    Primary Completion
    Mar 2018
    Completion
    Jun 2018
    NCT03109730
  • Phase 1
    Unknown status

    An Open-Label, Single- and Multi-Dose Pharmacokinetic (PK) Study of Oral Diltiazem and Topical Diltiazem Hydrochloride

    Diltiazem Hydrochloride Cream and Oral Diltiazem

    Adult Subjects With Anal Fissures.

    Enrollment
    12
    Start
    Feb 2013
    Primary Completion
    Jul 2013
    Completion
    Sep 2013est.
    NCT01816191
  • Phase 1
    Unknown status

    Topical Safety Study of Topical Diltiazem Hydrochloride

    Diltiazem Hydrochloride 2% Cream, Vehicle Cream

    Diltiazem Skin Sensitivity.

    Enrollment
    200
    Start
    Mar 2013
    Primary Completion
    Jun 2013
    Completion
    Sep 2013est.
    NCT01816529
  • Phase 1
    Unknown status

    A 21-Day Topical Safety Study of Diltiazem Hydrochloride Using a Cumulative Irritant Patch Test Design

    Diltiazem Hydrochloride 2% Cream, Vehicle Cream

    Skin Irritation

    Enrollment
    30
    Start
    Mar 2013
    Primary Completion
    Jul 2013
    Completion
    Sep 2013est.
    NCT01821274
  • Phase 1
    Completed

    Study to Evaluate the Interaction Potential of Clarithromycin XL on Diltiazem Hydrochloride Cream 2% in Healthy Subjects

    Clarithromycin XL, 2% Diltiazem

    CLARITHROMYCIN/DILTIAZEM [VA Drug Interaction]

    Enrollment
    24
    Start
    Sep 2013
    Primary Completion
    Oct 2013
    Completion
    Oct 2013
    NCT02080780
  • Phase 1
    Completed

    A Study in Healthy Volunteers and Patients With Chronic Hepatitis B

    ABI-H0731, Placebo for ABI-H0731

    Chronic Hepatitis B

    Enrollment
    86
    Start
    Nov 2016
    Primary Completion
    Mar 2018
    Completion
    Jun 2018
    NCT02908191
  • Phase 1
    Completed

    A Study of ABI-H2158 in Healthy Volunteers and Patients With Chronic Hepatitis B

    ABI-H2158, Placebo for ABI-H2158

    Chronic Hepatitis B

    Enrollment
    80
    Start
    Nov 2018
    Primary Completion
    Nov 2020
    Completion
    Jan 2021
    NCT03714152
  • Phase 1
    Terminated

    ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative Colitis

    ABI-M201, Placebo

    Ulcerative Colitis Chronic Mild, Ulcerative Colitis Chronic Moderate

    Enrollment
    15
    Start
    Jun 2019
    Primary Completion
    Jan 2021
    Completion
    Jan 2021
    NCT03923478
  • Phase 1
    Completed

    A Study to Assess the Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adults

    ABI-H2158 Reference Formulation, ABI-H2158 Test Formulation

    Chronic Hepatitis B

    Enrollment
    15
    Start
    Sep 2019
    Primary Completion
    Oct 2019
    Completion
    Oct 2019
    NCT04083716
  • Phase 1
    Completed

    A Study to Assess CYP3A4 Modulator, Oral Contraceptive, and pH Modifier Drug Interactions for ABI-H2158 in Healthy Adults

    ABI-H2158, Itraconazole

    Chronic Hepatitis B

    Enrollment
    80
    Start
    Oct 2019
    Primary Completion
    Jan 2020
    Completion
    Jan 2020
    NCT04142762
  • Phase 1
    Completed

    A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABI-H3733 in Healthy Adults

    ABI-H3733 Liquid Oral Dosage Form, ABI-H3733 Solid Oral Dosage Form

    Chronic Hepatitis B

    Enrollment
    120
    Start
    May 2020
    Primary Completion
    Nov 2020
    Completion
    Jan 2021
    NCT04271592
  • Phase 1
    Completed

    A Study to Evaluate the Mass Balance Absorption and AME of VBR

    Vebicorvir (VBR)

    Chronic Hepatitis B

    Enrollment
    6
    Start
    Dec 2020
    Primary Completion
    Dec 2020
    Completion
    Dec 2020
    NCT04637139
  • Phase 1
    Completed

    A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus Infection

    ABI-H3733, Placebo

    Chronic Hepatitis B

    Enrollment
    31
    Start
    Aug 2022
    Primary Completion
    Apr 2023
    Completion
    Apr 2023
    NCT05414981
  • Phase 1
    Completed

    A First in Human Study to Assess Safety, Tolerability, Pharmacokinetics of ABI-4334 in Healthy Subjects

    ABI-4334 Tablet, ABI-4334 Placebo

    Chronic Hepatitis B

    Enrollment
    54
    Start
    Nov 2022
    Primary Completion
    Apr 2023
    Completion
    Apr 2023
    NCT05569941

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