SOUTH SAN FRANCISCO – Assembly Biosciences, Inc. revealed… (NASDAQ:), a biotechnology company focused on serious viral diseases, reported promising interim results from a Phase 1b study of its drug candidate ABI-4334, which aims to treat chronic hepatitis B virus (HBV). ) infection. The study noted favorable safety and pharmacokinetic properties, in addition to significant antiviral activity in patients. The company, currently worth $93.56 million, has shown strong performance in the market with a 49.58% year-to-date return, according to InvestingPro Data.
The first study group, which received a daily oral dose of 150 mg of ABI-4334 for 28 days, showed a median reduction of 2.9 log 10 IU/mL in hepatitis B virus DNA levels. In addition, a median reduction was observed of 2.5 log10 U/mL in HBV RNA among participants with detectable HBV RNA at baseline. These results are consistent with the high efficacy of ABI-4334 seen in preclinical studies.
Safety data for participants in both the initial and continuation cohorts indicated that ABI-4334 was well tolerated with no serious adverse events or discontinuations due to adverse events reported. The treatment demonstrated a half-life that supported once-daily dosing and achieved plasma concentrations expected to be effective against the virus and inhibit cccDNA formation.
Enrollment in the final 400 mg cohort is currently underway, with results expected in the first half of 2025. If the study concludes successfully, Assembly Biosciences and its partner Gilead Sciences, Inc. will guide the study. (NASDAQ:) in deciding to further develop and market the drug. InvestingPro The analysis indicates that the company maintains a strong financial health score of 3.14 (Great), with analysts setting price targets between $35-36, indicating significant upside potential. Get 8 additional exclusive InvestingPro tips and comprehensive financial analysis to make informed investment decisions.
ABI-4334 is still under investigation and has not received approval for use. Interim results of the Phase 1b study are based on a press release and have not been independently verified. It is expected that full data from the experiment will be presented at future scientific meetings. Additional details about the study can be found at clinicaltrials.gov with identifier NCT06384131.
Assembly Biosciences is focused on developing treatments for herpes virus, hepatitis C virus, and hepatitis delta virus (HDV) infections. The company's collaboration with Gilead Sciences involves financial aspects and equity investments, with Gilead retaining the option to further develop and commercialize ABI-4334 following the trial. according to InvestingPro According to the data, the company holds more cash than debt on its balance sheet and maintains strong liquidity with a current ratio of 2.36, making it well-positioned to continue R&D activities.
In other recent news, Assembly Biosciences has entered into a revised collaboration agreement with Gilead Sciences. The revised terms include an immediate $10 million payment from Gilead and a restructured subscription fee for its drug candidate ABI-6250. At the same time, Assembly Biosciences launched a market equity program with Jefferies LLC, providing a flexible mechanism to raise capital.
Additionally, Gilead exercised its option to purchase additional shares in Assembly Biosciences, acquiring 940,499 shares. Assembly Biosciences also announced positive interim results from a Phase 1a study of its recurrent genital herpes drug candidate, ABI-5366, indicating a favorable safety profile and potential for once-weekly or once-monthly dosing schedules.
In response to these developments, several analysis firms have provided their views. HC Wainwright maintained a neutral stance towards the Society for Biological Sciences, Mizuho (NYSE:) Securities reiterated an Outperform rating, and Jefferies upgraded its rating from Hold to Buy. These are the latest developments that investors are expected to be watching closely.
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