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Assembly Biosciences, Inc. (ASMB)

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Neutralpattern detected
Previous Close5.70
Open5.80
Bid6.01 x 1000
Ask6.11 x 800
Day's Range5.79 - 6.14
52 Week Range4.78 - 27.84
Volume1,256,515
Avg. Volume991,007
Market Cap198.134M
Beta (5Y Monthly)1.32
PE Ratio (TTM)N/A
EPS (TTM)-1.49
Earnings DateNov 05, 2020
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est22.60
  • Assembly Biosciences Appoints Nicole S. White, PhD, as Senior Vice President of Pharmaceutical Development and Manufacturing
    GlobeNewswire

    Assembly Biosciences Appoints Nicole S. White, PhD, as Senior Vice President of Pharmaceutical Development and Manufacturing

    SOUTH SAN FRANCISCO, Calif., Nov. 17, 2020 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome, today announced the appointment of Nicole S. White, PhD, as Senior Vice President of Pharmaceutical Development and Manufacturing. Dr. White brings over 20 years of experience overseeing the complexities of the chemistry manufacturing and controls process. “Nicole will be a tremendous asset to Assembly Bio as we continue to progress our clinical development efforts, and we are thrilled to welcome her to the company,” said John McHutchison, AO, MD, Chief Executive Officer and President. “She is an established leader with proven success guiding programs throughout the entirety of the clinical lifecycle and ultimately to production of the commercial supply. Nicole will play a key strategic role in the advancement of our pipeline of core inhibitors, including vebicorvir, which we are preparing for Phase 3 studies next year.”"I am excited to join the leadership team at Assembly Bio and to work alongside this group of world-class experts in virology,” said Dr. White. “The potential for core inhibitors to improve outcomes for people with HBV is something that I have followed with great interest, and I am eager to apply my experience and strong technical background to support the company’s commitment to bring new and long overdue treatment options to patients with chronic HBV.”Prior to joining Assembly Bio, Dr. White headed Process Chemistry at Gossamer Bio and led chemistry, manufacturing and controls (CMC) for multiple early- and late-stage programs in development. Prior to that she held progressive leadership roles at Gilead Sciences to advance multiple programs from Phase 1 through commercial launch and helped guide the drug substance manufacturing and global outsourcing strategy. While at Gilead, Dr. White contributed to the development and commercial launch of multiple antiviral programs including Harvoni®, Vemlidy® and Vosevi®. She obtained a PhD in Organic Chemistry from the University of California, Irvine and a BS in Chemistry from the University of California, San Diego.About Assembly Biosciences Assembly Biosciences, Inc. is a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome. The HBV program is focused on advancing a new class of potent, oral core inhibitors that have the potential to increase cure rates for chronically infected patients. The microbiome program is developing novel oral live microbial biotherapeutic candidates with Assembly’s fully integrated platform, including a robust process for strain identification and selection, GMP manufacturing expertise and targeted delivery to the lower gastrointestinal tract with the GEMICEL® technology. For more information, visit assemblybio.com.Forward-Looking Statements The information in this press release contains forward-looking statements regarding future events, including statements about the therapeutic potential of our HBV product candidates. Certain forward-looking statements may be identified by reference to a future period or by use of forward-looking terminology such as “will,” “advance,” and “progress.” 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.Investor Contact Assembly Biosciences, Inc. Lauren Glaser Senior Vice President, Investor Relations and Corporate Affairs (415) 521-3828 lglaser@assemblybio.comMedia Contact Sam Brown Inc. Audra Friis (917) 519-9577 ASMBMedia@sambrown.com

  • Assembly Biosciences and Door Pharmaceuticals Sign Collaboration and Option Agreement to Develop a Novel Class of HBV Core Protein Modulators
    GlobeNewswire

    Assembly Biosciences and Door Pharmaceuticals Sign Collaboration and Option Agreement to Develop a Novel Class of HBV Core Protein Modulators

    SOUTH SAN FRANCISCO, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB) and Door Pharmaceuticals, LLC today announced that the companies have signed an exclusive, two-year collaboration and option agreement focused on the development of a novel class of hepatitis B virus (HBV) core protein modulators. Door Pharmaceuticals’ innovative discovery platform targets functions of core protein distinct from viral assembly and that have the potential to interfere with viral nucleic acid including cccDNA transcription, providing a strong complement to Assembly Bio’s current portfolio. Under the terms of the agreement, Door Pharmaceuticals will build upon its previous efforts to lead and conduct new discovery research, which will be funded by Assembly Bio. In return for an up-front payment and success-based milestones and royalties, Assembly Bio will be granted an exclusive option to license compounds arising from the collaboration and will be responsible for the continued development and commercialization of optioned compounds. Financial details were not disclosed.“Door Pharmaceuticals was established by our co-founder, Adam Zlotnick, whose research led to the successful discovery of the core inhibitor candidates that comprise Assembly Bio’s clinical program,” said William Delaney, PhD, Chief Scientific Officer, Virology of Assembly Biosciences. “Adam is a true innovator, and this collaboration is a natural continuation of our work together. We’re excited to build upon our current pipeline of HBV core inhibitors with additional contributions from a science-driven company that shares our passion and focus for bringing new treatment options to patients facing HBV.”“I’m thrilled at the opportunity to once again contribute to the advancement of Assembly Bio’s core inhibitor platform under this new collaboration,” said Adam Zlotnick, PhD, Founder of Door Pharmaceuticals. “There is a clear mechanistic rationale for the potential role that core inhibitors can play in the treatment of HBV, and it is our hope and belief that the complementary mechanisms of action of these core protein modulators will offer an important therapeutic pathway towards HBV cure.”About HBV Chronic hepatitis B virus (HBV) infection is a debilitating disease of the liver that afflicts over 250 million people worldwide with up to 90 million people in China, as estimated by the World Health Organization. HBV is a global epidemic that affects more people than hepatitis C virus (HCV) and HIV infection combined—with a higher morbidity and mortality rate. HBV is a leading cause of chronic liver disease and need for liver transplantation, and up to one million people worldwide die every year from HBV-related causes.The current standard of care for patients with chronic HBV infection is life-long suppressive treatment with medications that reduce, but do not eliminate, the virus, resulting in very low cure rates. There is a significant unmet need for new therapies to treat HBV.About Assembly Biosciences Assembly Biosciences, Inc. is a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome. The HBV program is focused on advancing a new class of potent, oral core inhibitors that have the potential to increase cure rates for chronically infected patients. The microbiome program is developing novel oral live microbial biotherapeutic candidates with Assembly Bio’s fully integrated platform, including a robust process for strain identification and selection, GMP manufacturing expertise and targeted delivery to the lower gastrointestinal tract with the GEMICEL® technology. For more information, visit assemblybio.com.About Door Pharmaceuticals Door Pharmaceuticals was founded in 2018 by leading HBV researcher, Adam Zlotnick, PhD, a professor of molecular and cellular biochemistry at Indiana University; he is also a fellow of the American Academy of Microbiology and of the AAAS. The company is focused on research of virus structural proteins to discover new classes of inhibitors. The company is initially focused on HBV, with the vision to realize the potential for novel therapeutics for other viruses.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: the Door collaboration may not yield any novel assets and we may not exercise our option with respect to any collaboration compounds; Assembly Bio’s ability to initiate and complete clinical trials involving its HBV therapeutic product candidates in the currently anticipated timeframes; safety and efficacy data from clinical studies may not warrant further development of Assembly Bio’s product candidates; clinical and nonclinical data presented at conferences may not differentiate Assembly Bio’s product candidates from other companies’ candidates; Assembly Bio may not observe sustained virologic response in patients who stop therapy in Study 211; Assembly Bio’s ability to maintain financial resources necessary to continue its clinical trials and fund business operations; any impact that the spread of the coronavirus and resulting COVID-19 pandemic may have on Assembly Bio’s business and operations, including initiation and continuation of its clinical trials or timing of discussions with regulatory authorities; 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 Assembly Biosciences, Inc. Lauren Glaser Senior Vice President, Investor Relations and Corporate Affairs (415) 521-3828 lglaser@assemblybio.comMedia Contact Sam Brown Inc. Audra Friis (917) 519-9577 ASMBMedia@sambrown.com

  • Assembly Biosciences Presents Data from HBV Core Inhibitor Programs in Poster Sessions at the 2020 AASLD The Liver Meeting Digital Experience™
    GlobeNewswire

    Assembly Biosciences Presents Data from HBV Core Inhibitor Programs in Poster Sessions at the 2020 AASLD The Liver Meeting Digital Experience™

    \- Data show longer-term, differentiated safety profile of vebicorvir and the importance of HBV pregenomic (pg) RNA as a key biomarker, as well as highlight Assembly Bio’s core inhibitor clinical pipeline -SOUTH SAN FRANCISCO, Calif., Nov. 13, 2020 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome, today announced that data from its HBV core inhibitor programs and related research will be highlighted during four poster sessions – including two late-breakers – at the 2020 American Association for the Study of Liver Diseases (AASLD) The Liver Meeting Digital ExperienceTM. The posters include data from the company’s HBV core inhibitor research and development programs, as well as a collaborative translational study using Assembly Bio’s sensitive HBV nucleic acid assays.“Findings from these studies are adding to a growing body of clinical data that supports the differentiated safety profile of vebicorvir in combination with nucleos(t)ide therapy,” said Ira M. Jacobson, MD, Director of Hepatology at New York University Langone Medical Center. “New treatment options for HBV patients are long overdue and the addition of a core inhibitor to the standard-of-care regimen may offer better chronic suppressive therapy to a significant patient population. These longer-term safety data, along with the demonstrated association of HBV pgRNA and changes in HBV viral antigens presented at this conference, are very encouraging and support the continued advancement of the company’s core inhibitor programs.”  “Chronic hepatitis B virus infection is incredibly complex. Through this research, we are proud to continue to contribute to the scientific community’s understanding of hepatitis B and the importance of deepening virologic suppression as it relates to both improving chronic suppressive therapy and reducing downstream clinically important liver-related events,” said John McHutchison, AO, MD, Chief Executive Officer and President at Assembly Biosciences. “Further, these data highlight the potential of our more potent core inhibitor candidates, ABI-H2158 and ABI-H3733. We believe that core inhibitors represent a significant advancement in the HBV field and we remain focused on upcoming milestones, including planned Phase 3 registrational trials of vebicorvir in China and globally in the first half of 2021.”   The Liver Meeting Digital Experience 2020 Presentations: The posters will be made available on the “Events and Presentations” page in the Investors section of assemblybio.com.Vebicorvir (VBR, or ABI-H0731), Assembly Bio’s Lead HBV Core Inhibitor Poster Presentation 820: Analysis of the longer-term safety profile of the hepatitis B virus core inhibitor VBR in an open-label extension study Presenter: Ira M. Jacobson, MD, Director, Hepatology, NYU Langone HealthThis poster includes data from a controlled comparison of 24 patients receiving placebo + nucleos(t)ide analogs (NrtI) for 24 weeks versus 95 patients receiving Assembly Bio’s lead core inhibitor product VBR + NrtI for up to 1.5 years. Data support the differentiated safety profile and continued development of VBR combination therapy.Key Results: * The safety profile of combination treatment with VBR+NrtI was similar to placebo+NrtI over a 24-week controlled-comparison and was stable with longer-term treatment of VBR+NrtI up to 1.5 years. * Rashes without systemic involvement observed with VBR+NrtI treatment were predominantly Grade 1 resolving without VBR+NrtI interruption. * There was no pattern of increased alamine aminotransferase (ALT) and/or aspartate aminotransferase (AST), indicative of hepatoxicity. Late-Breaking Poster LP37: Changes in viral antigens are more strongly associated with HBV pgRNA than HBV DNA in studies of vebicorvir and NrtI in treatment-naive patients with chronic HBV infection Presenter: Mark Sulkowski, MD, Medical Director, Viral Hepatitis Center, Johns Hopkins University School of MedicineThis poster details the results of post hoc analyses of data from studies of VBR in treatment naïve patients with HBeAg positive chronic HBV infection to better understand the correlations between changes in HBV DNA and pgRNA with those of other HBV antigens. Two approaches were used: correlation analyses with a Pearson’s coefficient and a Mixed-Effects Model for Repeated Measures. These results demonstrate the importance of pgRNA as a meaningful biomarker for chronic HBV.Key Results: * Changes in other HBV antigens are more strongly associated with the change in pgRNA compared with the change in HBV DNA. * Correlations between pgRNA and HBeAg and HBcrAg were greater relative to the correlations with HBsAg, likely due to the substantial contribution of HBV integrants to HBsAg levels. * A >2 log10 decline in pgRNA in patients receiving VBR + entecavir (ETV) more significantly predicted the decline in the HBeAg and HBcrAg consistent with the second phase decline with core inhibitor treatment reflecting reduction in cccDNA pools.Assembly Bio’s Next-Generation of Core Inhibitors Late-Breaking Poster LP45: Amino acid substitutions in the inhibitor binding pocket of HBV core protein confer differential changes in susceptibility to three generations of HBV core inhibitors Presenter: Dawei Cai, PhD, Senior Scientist, Assembly BioThis poster describes the in vitro resistance profiles of Assembly Bio’s first-generation core inhibitor, VBR, and next-generation core inhibitor candidates ABI-H2158 (2158) and ABI-H3733 (3733). Researchers evaluated the antiviral activity of these candidates against known substitutions to the core inhibitor binding pocket. They also assessed whether these substitutions affect the ability of core inhibitors to block cccDNA formation as well as HBV replication through inhibition of pgRNA encapsidation.Key Results: * 2158 and 3733 showed greater potency in terms of preventing cccDNA formation compared with VBR and had more favorable resistance profiles against a panel of substitutions. * ETV retains activity against all tested core protein substitutions suggesting that combination therapy with NrtIs will prevent viral breakthrough due to pre-existence or potential emergence of core protein substitutions, consistent with the current clinical data.Use of Assembly Bio’s Highly Sensitive HBV Assays to Characterize the Association of HBV with HCC Poster 738: Persistently detectable serum HBV pgRNA is associated with subsequent HCC development in chronic hepatitis B patients receiving chronic NrtI treatment Presenter: Lung-Yi Mak, MBBS, MRCP, PDipID, FHKCP, FHKAM Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong KongIn this poster, researchers detail findings from a case control study to assess whether residual HBV viraemia is associated with the development of hepatocellular carcinoma (HCC), the most common type of primary liver cancer. The study evaluated 104 chronic HBV patients, 39% of whom had cirrhosis, on ≥ 3 years ETV with unquantifiable HBV DNA by standard assays. Findings highlight the need for more potent viral suppression to further reduce the risk of HCC.Key Results: * More sensitive assays revealed that patients still had ongoing replication as evidenced by detection of HBV DNA and pgRNA. * More than 50% of chronic HBV patients on ETV with HBV DNA