Welcome to our dedicated page for Assembly Bioscie news (Ticker: ASMB), a resource for investors and traders seeking the latest updates and insights on Assembly Bioscie stock.
Assembly Biosciences, Inc. (ASMB) news on Stock Titan centers on the company’s progress in developing small-molecule therapeutics for serious viral diseases. Assembly Bio describes itself as a biotechnology company focused on herpesvirus, hepatitis B virus (HBV) and hepatitis delta virus (HDV) infections, and its news flow reflects clinical, scientific and corporate developments across these areas.
Investors following ASMB news can expect regular updates on clinical trial milestones. Recent press releases detail interim Phase 1b results for long-acting HSV helicase-primase inhibitor candidates ABI-5366 and ABI-1179 in participants with recurrent genital herpes, including reported reductions in HSV-2 shedding rates, high viral load shedding and genital lesion rates in certain dosing cohorts. News items also cover Phase 1b data for ABI-4334, a next-generation capsid assembly modulator candidate in chronic HBV infection, and Phase 1a interim data for ABI-6250, an oral HDV entry inhibitor candidate evaluated in healthy participants.
Another key theme in Assembly Bio’s news is its collaboration with Gilead Sciences. Company announcements describe Gilead’s rights to opt in to exclusive licenses for specific programs and report that Gilead has exercised its combined option to license the HSV helicase-primase inhibitor programs ABI-5366 and ABI-1179 for recurrent genital herpes. These items provide context on how the collaboration may influence development responsibilities, potential milestones and royalty structures.
Financial and corporate updates also feature prominently in ASMB news. Quarterly results outline collaboration revenue from Gilead, research and development spending on HSV, HBV and HDV programs, and general and administrative expenses. Additional releases describe equity financings, including an underwritten offering of common stock and warrants and a private placement with Gilead, along with the intended use of proceeds for general corporate purposes.
For investors and observers, the ASMB news feed offers a consolidated view of Assembly Biosciences’ clinical data disclosures, collaboration developments, financing activities and participation in scientific and investor conferences. Bookmarking this page can help track how the company’s antiviral pipeline and partnership with Gilead evolve over time.
Assembly Biosciences (Nasdaq: ASMB) has reported promising interim Phase 1a data for ABI-6250, their oral hepatitis delta virus (HDV) entry inhibitor candidate. The study demonstrated a four-day half-life, supporting once-daily oral dosing, and showed dose-dependent elevations in total serum bile acids, indicating effective target engagement.
Key findings include successful completion of two single-dose cohorts (5mg and 25mg) and three multiple-dose cohorts (0.05mg, 0.2mg, and 1mg). Safety data showed mostly Grade 1 adverse events, with one Grade 2 ALT elevation in the highest dose cohort. All ALT elevations were self-limited without signs of liver injury.
The company plans to conduct additional pharmacological assessment while preparing for Phase 2 studies, positioning ABI-6250 as potentially the first oral therapy for chronic HDV infection.
Assembly Biosciences (NASDAQ:ASMB) presented Phase 1a clinical data for two novel herpes simplex virus (HSV) treatments, ABI-5366 and ABI-1179, at the STI & HIV 2025 World Congress and International Herpesvirus Workshop. The drug candidates, designed as helicase-primase inhibitors, demonstrated promising safety and pharmacokinetic profiles in healthy participants.
Key highlights include the potential for once-weekly dosing for both treatments, and once-monthly dosing for ABI-5366, representing a significant improvement over current daily dosing requirements. Both candidates showed no clinically significant food effects and are now advancing to Phase 1b trials, with interim proof-of-concept data expected in fall 2025.
Assembly Biosciences (Nasdaq: ASMB) has initiated the Phase 1b portion of its Phase 1a/b clinical trial for ABI-1179, a long-acting herpes simplex virus (HSV) helicase-primase inhibitor. The study will evaluate weekly oral doses over 29 days in participants with recurrent genital herpes, focusing on safety and antiviral activity.
The company reported that ABI-1179 demonstrated promising Phase 1a results, showing a pharmacokinetic profile supporting once-weekly oral dosing and low nanomolar potency against both HSV-1 and HSV-2 in vitro. Assembly Bio has received IND clearance to expand the study to U.S. sites.
Notably, Assembly Bio is conducting concurrent Phase 1b studies for both ABI-1179 and ABI-5366, with interim data expected in fall 2025. Under a collaboration agreement, Gilead Sciences maintains the right to opt in for an exclusive license for further development and commercialization of both candidates following review of the Phase 1b data package.
Assembly Biosciences (NASDAQ:ASMB) announced positive topline results from its Phase 1b clinical trial of ABI-4334, a next-generation capsid assembly modulator (CAM) for chronic hepatitis B virus treatment. The trial evaluated two dosage cohorts: 150mg and 400mg daily over 28 days.
Key findings include mean HBV DNA reductions of 2.9 and 3.2 log10 IU/mL in the 150mg and 400mg cohorts respectively. The drug demonstrated favorable safety and tolerability profiles, with pharmacokinetics supporting once-daily oral dosing. The 150mg dose achieved saturated inhibition of viral replication, while the 400mg dose reached exposure levels targeting inhibition of cccDNA formation.
The trial completion triggers Gilead Sciences' opt-in opportunity for an exclusive license to further develop and commercialize ABI-4334.
Assembly Biosciences (NASDAQ: ASMB), a biotechnology company focused on developing therapeutics for viral diseases, has announced its participation in the upcoming Jefferies 2025 Global Healthcare Conference. CEO and President Jason Okazaki, along with Chief Medical Officer Dr. Anuj Gaggar, will engage in a fireside chat on June 4, 2025, at 8:45 a.m. ET. The presentation will be accessible via live webcast on the company's website, with a replay available afterward through their investor relations portal.
Syndeio Biosciences has launched with over $90 million in funding to develop synapse-targeted neurotherapeutics. The company's lead candidate, zelquistinel, is currently in Phase 2 trials for major depressive disorder and will soon begin trials for Alzheimer's disease. The company is backed by prominent investors including Catalio Capital Management, Innoviva, with AbbVie and Lilly as strategic shareholders.
The company's leadership includes experienced neurotherapeutics entrepreneurs and Nobel Laureate Thomas C. Südhof. Their proprietary Boost™ Synapse Pharmacology Platform integrates various models to predict treatment outcomes for synaptogenic agents. Additionally, Syndeio is advancing apimostinel, another investigational therapy for acute MDD treatment, in a Phase 2a study with the University of Pittsburgh.
The company aims to address significant unmet needs in viral hepatitis treatment, with HDV being the most serious form affecting liver health, and HBV affecting 254 million people globally with 1.1 million deaths in 2022.
Assembly Biosciences (NASDAQ: ASMB) presented new data for its herpes simplex virus (HSV) program at the 2025 ESCMID Congress, featuring clinical and preclinical results for ABI-5366, a novel long-acting helicase-primase inhibitor candidate.
Key findings from the Phase 1a study showed ABI-5366 was well-tolerated up to 350mg with no serious adverse events. The drug demonstrated an approximate 20-day half-life, supporting potential once-weekly or monthly oral administration. Preclinical studies revealed broad activity against both HSV-1 and HSV-2.
A retrospective analysis of U.S. healthcare data identified 262,457 total genital herpes cases and 148,067 recurrent cases in 2023. When extrapolated to the U.S. population, approximately 1.35 million individuals experience recurrent genital herpes, with over 800,000 receiving chronic or intermittent suppressive therapy.
The company expects to report interim Phase 1b data for both ABI-5366 and ABI-1179 in fall 2025.
Assembly Biosciences (ASMB) reported its financial results for 2024, highlighting progress across its antiviral pipeline. The company ended 2024 with $112.1 million in cash, projecting operations funding into mid-2026. Revenues increased to $28.5 million from $7.2 million in 2023, while net loss decreased to $40.2 million ($6.69 per share) from $61.2 million in 2023.
Key clinical developments include positive Phase 1a interim data for ABI-1179 for recurrent genital herpes, supporting once-weekly oral dosing. The company's ABI-4334 for chronic HBV infection showed promising results with a 2.9 log10 IU/mL mean decline in HBV DNA. ASMB initiated Phase 1a study for ABI-6250 for hepatitis delta virus and advanced ABI-7423 into IND/CTA-enabling studies.
The company received a $20.1 million equity investment and $10 million in accelerated funding from Gilead Sciences to advance clinical development programs.