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Assembly Biosciences, Inc. - ASMB STOCK NEWS

Welcome to our dedicated page for Assembly Biosciences news (Ticker: ASMB), a resource for investors and traders seeking the latest updates and insights on Assembly Biosciences stock.

Assembly Biosciences, Inc. (NASDAQ: ASMB) is a public clinical-stage biotechnology company dedicated to advancing innovative therapies for serious viral diseases. The company focuses on two key platform programs: the treatment of Hepatitis B virus (HBV) infection and the development of novel oral live biotherapeutics for disorders associated with the microbiome.

In the HBV program, Assembly Biosciences is pioneering a new class of oral therapeutics aimed at increasing cure rates for patients with chronic HBV. The company has developed several drug candidates that inhibit various steps in the HBV lifecycle, including novel core protein allosteric modulators (CpAMs). These small molecules target and modulate the HBV core protein, a crucial component in the virus's replication process.

The microbiome program is designed to address diseases linked to dysbiosis, an imbalance in the microbial community of the gut. Assembly Biosciences employs a robust strain identification and selection process, methods for strain isolation and growth under Good Manufacturing Practices (GMP), and a patent-pending delivery system known as GEMICEL®. This system ensures targeted delivery of live biotherapeutics to specific areas in the gastrointestinal tract.

Recent achievements for Assembly Biosciences include a long-term partnership with Gilead Sciences to accelerate the development of their antiviral pipeline. This collaboration is expected to enhance the company's financial and scientific resources, positioning them to achieve critical milestones and deliver innovative treatments to patients.

Financial results for the third quarter of 2023 highlighted the company's ongoing progress, including the advancement of multiple antiviral candidates targeting herpesviruses, HBV, and hepatitis delta virus (HDV). Assembly Biosciences also announced leadership enhancements, including the appointment of Dr. Anuj Gaggar as Chief Medical Officer.

Looking ahead, Assembly Biosciences plans to have four candidates in clinical studies by the end of 2024. These include the initiation of trials for ABI-5366, a long-acting herpes simplex virus helicase-primase inhibitor, and the development of ABI-6250, an orally bioavailable small molecule for treating chronic HDV.

For more information, visit assemblybio.com.

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Assembly Biosciences (Nasdaq: ASMB) presented new preclinical data on its investigational helicase-primase inhibitors for recurrent genital herpes at the International Herpesvirus Workshop. The company highlighted promising results for two candidates: ABI-5366 and ABI-1179.

Key findings for ABI-5366 include low nanomolar activity against HSV-1 and HSV-2, specificity for HSV, and a favorable safety profile. The Phase 1a/b study for ABI-5366 began in May 2024, with interim Phase 1a data expected in Q3 2024.

ABI-1179, licensed from Gilead Sciences, demonstrated potent activity against HSV strains, including acyclovir-resistant isolates, and showed potential for once-weekly oral dosing. Assembly Bio plans to initiate a Phase 1a/b study for ABI-1179 by the end of 2024.

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Assembly Biosciences (Nasdaq: ASMB) has dosed the first participant in its Phase 1b clinical trial for ABI-4334, a next-generation capsid assembly modulator (CAM) targeting chronic hepatitis B virus (HBV) infection. The trial aims to evaluate the safety, pharmacokinetics, and efficacy of ABI-4334 over a 28-day period. Interim data is expected by the end of 2024. ABI-4334 has shown promising preclinical results with strong antiviral activity and is optimized to inhibit HBV DNA replication and prevent cccDNA formation. Chronic HBV is a leading cause of chronic liver disease and liver transplants, making this study important for potential therapeutic advancements.

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Assembly Biosciences announced the closure of $12.6 million in equity financings from Armistice Capital and Gilead Sciences. The funds will support Assembly's antiviral portfolio, with clinical data readouts expected for ABI-5366 and ABI-4334 in the coming years.

The equity financings involve the sale of common stock and warrants at $15.46 per share with warrants exercisable at $17.00. These transactions extend Assembly's cash runway into Q1 2026 and maintain Gilead's 19.9 percent ownership, with an option to increase up to 29.9 percent.

Assembly intends to use the proceeds for general corporate purposes and further advance its clinical candidates, with significant near-term milestones anticipated.

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Assembly Biosciences has initiated a Phase 1a/b clinical trial for ABI-5366, a new helicase-primase inhibitor targeting herpes simplex virus (HSV). The Phase 1a trial involves single ascending doses in healthy participants, with interim data expected by Q3 2024. Phase 1b will start by the end of the year with multiple ascending weekly doses in patients with recurrent genital herpes, with interim data expected in the first half of 2025. ABI-5366 has shown strong potential in preclinical studies, potentially offering a long-acting treatment for HSV-1 and HSV-2. Existing treatments are and not fully effective, highlighting the need for new therapeutic options in this area.

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Assembly Biosciences showcased new preclinical data for ABI-6250, an orally bioavailable hepatitis D virus (HDV) entry inhibitor, at the EASL Congress 2024. The data underline ABI-6250's potential to block HDV from entering cells, targeting the NTCP bile acid transporter with high selectivity. The preclinical results showed effective inhibition of HDV infection and NTCP-mediated bile acid uptake, supporting once-daily oral dosing. Clinical trials are expected to begin by the end of 2024. Chronic HDV is a severe viral hepatitis form, leading to liver complications and potential death. ABI-6250 promises to be a significant therapeutic innovation in viral hepatitis treatment.

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Assembly Biosciences (Nasdaq: ASMB) will present preclinical data from its HSV and HDV therapeutics at the International Herpesvirus Workshop (July 13-17, 2024) and EASL Congress 2024 (June 5-8, 2024). Data for ABI-5366 and ABI-1179, targeting recurrent genital herpes, will be featured in one oral and two poster presentations. ABI-6250, aimed at treating chronic hepatitis D, will be presented as a poster. The company anticipates starting clinical trials for ABI-5366 mid-year and for ABI-1179 and ABI-6250 by the end of 2024.

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Assembly Biosciences, Inc. (Nasdaq: ASMB) reported financial results for Q1 2024, including regulatory clearances for Phase 1 trials for ABI-5366 targeting recurrent genital herpes and ABI-4334 in chronic HBV infection. The company highlighted upcoming clinical milestones, abstract acceptance for ABI-6250 at EASL CongressTM 2024, and financial results showing $113.0 million in cash as of March 31, 2024. Revenues from collaborative research were $5.8 million, with research and development expenses at $11.9 million and a net loss of $9.1 million for Q1 2024.

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Assembly Biosciences, Inc. reported financial results for Q4 2023 and year-end 2023, showcasing progress in antiviral pipeline development. The company entered a partnership with Gilead Sciences, strengthened leadership, and filed a clinical trial application for ABI-5366. Anticipated milestones include interim data from Phase 1a studies by Q3 2024 and Phase 1b studies by end of 2024. Financially, the company's cash position improved significantly, with $130.2 million in cash, cash equivalents, and marketable securities as of December 31, 2023.
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Assembly Biosciences, Inc. (ASMB) announced a 1-for-12 reverse stock split of its outstanding shares, reducing the number of shares from approximately 65.8 million to approximately 5.5 million. The split will not affect the number of authorized shares or the par value of the common stock. The split is expected to bring the company into compliance with the minimum bid price requirement for maintaining its listing on The Nasdaq Global Select Market.
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Assembly Biosciences, a biotechnology company (Nasdaq: ASMB), plans to expand its R&D portfolio across herpesviruses and hepatitis B and D viruses. They anticipate four development candidates to be in the clinic by the end of 2024, with initial clinical data expected by the end of the year from the 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). Assembly Bio recently announced a long-term partnership with Gilead Sciences, Inc. to address serious viral diseases, expanding and building on the progress of their antiviral portfolio.
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FAQ

What does Assembly Biosciences, Inc. specialize in?

Assembly Biosciences specializes in developing innovative therapies for serious viral diseases, focusing on HBV and microbiome-related disorders.

What are the main programs of Assembly Biosciences?

The main programs are an HBV program for treating hepatitis B virus infection and a microbiome program developing novel oral live biotherapeutics.

What is the HBV program at Assembly Biosciences?

The HBV program aims to increase cure rates for chronic HBV patients using a new class of oral therapeutics that target various steps in the HBV lifecycle.

What is the microbiome program at Assembly Biosciences?

The microbiome program focuses on developing live biotherapeutics for diseases associated with the microbiome, using a targeted delivery system called GEMICEL®.

What recent achievements has Assembly Biosciences made?

Recent achievements include a partnership with Gilead Sciences, advancements in multiple antiviral candidates, and leadership enhancements such as the appointment of Dr. Anuj Gaggar as CMO.

What are the anticipated milestones for Assembly Biosciences in 2024?

Assembly Biosciences plans to have four clinical candidates in studies, including trials for ABI-5366 for herpes and ABI-6250 for chronic HDV.

How does Assembly Biosciences' GEMICEL® delivery system work?

GEMICEL® is a patent-pending system designed to deliver live biotherapeutics to specific regions of the gastrointestinal tract effectively.

What is the significance of the partnership with Gilead Sciences?

The partnership with Gilead Sciences provides Assembly Biosciences with financial and scientific resources to accelerate their antiviral pipeline and reach critical milestones.

Who is the CEO of Assembly Biosciences?

Jason Okazaki is the CEO and President of Assembly Biosciences.

Where can I find more information about Assembly Biosciences?

More information can be found on their official website at www.assemblybio.com.

Assembly Biosciences, Inc.

Nasdaq:ASMB

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