Assembly Unveils Encouraging Initial Trial Findings for ABI-1179 and ABI-5366 in Recurrent Genital Herpes
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 09 2025
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Source: NASDAQ.COM
Positive Interim Results: Assembly Biosciences reported promising interim results from Phase 1b trials of its oral drugs ABI-1179 and ABI-5366 for recurrent genital herpes, showing significant reductions in HSV-2 shedding and genital lesions compared to placebo.
ABI-1179 Findings: The 50 mg weekly dose of ABI-1179 demonstrated a 98% reduction in HSV-2 shedding and a 91% reduction in genital lesions, with the drug being well-tolerated and supporting once-weekly dosing.
ABI-5366 Findings: The monthly dosing of ABI-5366 showed a 76% reduction in HSV-2 shedding and an 88% reduction in genital lesions, with positive results from earlier weekly dosing cohorts as well.
Future Plans: Assembly Biosciences plans to initiate Phase 2 clinical trials for ABI-5366, focusing on a once-weekly regimen, around mid-2026.
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Analyst Views on ASMB
Wall Street analysts forecast ASMB stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for ASMB is 43.00 USD with a low forecast of 39.00 USD and a high forecast of 50.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
3 Analyst Rating
3 Buy
0 Hold
0 Sell
Strong Buy
Current: 25.710
Low
39.00
Averages
43.00
High
50.00
Current: 25.710
Low
39.00
Averages
43.00
High
50.00
About ASMB
Assembly Biosciences, Inc. is a biotechnology company, which is engaged in the development of small-molecule therapeutics designed to change the path of serious viral diseases and improve the lives of patients worldwide. Its pipeline includes multiple clinical-stage investigational therapies, including two helicase-primase inhibitors (HPI) targeting recurrent genital herpes; an orally bioavailable hepatitis delta virus (HDV) entry inhibitor, and a potent next-generation capsid assembly modulator (CAM) designed to disrupt the replication cycle of hepatitis B virus (HBV) at several key points. Its pipeline also includes a novel, oral broad-spectrum non-nucleoside polymerase inhibitor (NNPI) targeting transplant-related herpesviruses, which is undergoing studies to enable a regulatory filing, and it also has additional research programs against multiple antiviral targets. It is advancing two investigational long-acting HPI candidates, ABI-5366 (5366) and (2) ABI-1179 (1179).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Gilead Licenses Assembly Bio's HSV Programs, Secures $35 Million Investment
- Exclusive Licensing Agreement: Gilead Sciences has exercised its option to exclusively license Assembly Bio's HSV inhibitor programs, including ABI-1179 and ABI-5366, marking the first advancement under their R&D collaboration and potentially benefiting over four million patients.
- Positive Clinical Data: Interim Phase 1b data for ABI-5366 and ABI-1179 demonstrated antiviral activity with a significant reduction in virus-positive lesions, indicating promising clinical prospects for treating recurrent genital herpes.
- Clear Financial Terms: Under the 2023 collaboration agreement, Assembly Bio will receive a $35 million upfront payment and is eligible for up to $330 million in regulatory and commercial milestone payments, reflecting Gilead's commitment to the project's future potential.
- Significant Market Opportunity: Given that no new therapies have been approved for HSV in over 25 years, Gilead's initiative not only fills a market gap but also enhances its competitive position in the antiviral drug market by improving patient quality of life.
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Gilead Secures Exclusive License for Assembly Bio's HSV Programs, Receives $35M Payment
- Exclusive Licensing Agreement: Gilead Sciences has exercised its option to exclusively license Assembly Biosciences' HSV programs, gaining rights to clinical development and commercialization of ABI-1179 and ABI-5366, marking a strategic expansion in the antiviral sector.
- Financial Injection: Assembly Bio will receive a $35 million payment from Gilead's exercise of the license, which not only strengthens its financial position but also provides funding for future research and development efforts.
- Potential Earnings: Assembly Bio remains eligible for up to $330 million in regulatory and commercial milestone payments, along with tiered royalties on net sales, significantly enhancing its future revenue potential.
- Market Impact: Gilead's acquisition bolsters its market position in reproductive health, with expectations to accelerate the clinical development of related products, thereby securing a more advantageous stance in the competitive antiviral drug market.
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