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ASSEMBLY BIOSCIENCES (ASMB)

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Earnings summaries and quarterly performance for ASSEMBLY BIOSCIENCES.

Research analysts covering ASSEMBLY BIOSCIENCES.

Recent press releases and 8-K filings for ASMB.

Assembly Bio Announces Positive Phase 1b Results for Genital Herpes Candidates ABI-1179 and ABI-5366
ASMB
New Projects/Investments
Product Launch
  • Assembly Bio (ASMB) announced positive Phase 1b clinical study results for its recurrent genital herpes candidates, ABI-1179 and ABI-5366, with both meeting or exceeding key objectives.
  • ABI-1179 (50 mg weekly oral) achieved a 98% reduction in HSV-2 shedding and a 91% reduction in virologically confirmed genital lesions compared to placebo.
  • ABI-5366 (350 mg weekly regimen) demonstrated a 94% reduction in HSV-2 shedding, a 98% reduction in high viral load shedding, and a 97% reduction in virologically confirmed genital lesions compared to placebo.
  • The company plans to initiate a Phase 2 clinical study for ABI-5366 in mid-2026 and has begun Phase 2 enabling activities for ABI-1179, with a cash runway extending into late 2027.
Dec 8, 2025, 11:00 PM
Assembly Bio Announces Positive Interim Phase 1b Results for Genital Herpes Candidates ABI-1179 and ABI-5366
ASMB
Product Launch
New Projects/Investments
  • Assembly Bio (ASMB) announced positive interim Phase 1b clinical study results for its long-acting helicase-primase inhibitor candidates, ABI-1179 and ABI-5366, for recurrent genital herpes on December 8, 2025.
  • ABI-1179 demonstrated a 98% reduction in HSV-2 shedding (p<0.01) and a 91% reduction in virologically confirmed genital lesions (p<0.01) in the 50mg weekly cohort B1.
  • ABI-5366 showed a 94% reduction in HSV-2 shedding (p<0.01) and a 97% reduction in virologically confirmed lesion rate (p<0.05) in the 350mg weekly cohort B2.
  • Both candidates exhibited a clean safety profile with no serious adverse events or discontinuations due to treatment-emergent adverse events.
  • Phase 2 enabling activities are underway for ABI-1179, and Phase 2 planning for ABI-5366 is underway with study initiation expected mid-2026.
Dec 8, 2025, 11:00 PM
Assembly Bio Announces Positive Phase 1b Results for Genital Herpes Candidates
ASMB
New Projects/Investments
  • Assembly Bio announced impressive results from its Phase 1b clinical studies for long-acting helicase-primase inhibitor candidates, ABI-1179 and ABI-5366, in participants with recurrent genital herpes, with both candidates meeting or exceeding all key study objectives.
  • For ABI-1179, the 50 mg weekly regimen demonstrated a 98% reduction in HSV-2 shedding and a 91% reduction in virologically confirmed genital lesions compared to placebo.
  • For ABI-5366, the 350 mg weekly regimen showed a 94% reduction in HSV-2 shedding and a 97% reduction in virologically confirmed genital lesions compared to placebo.
  • A monthly dosing cohort for ABI-5366 showed potent antiviral activity but suggested additional work is needed to maintain the high level of suppression seen with weekly dosing.
  • The company expects to initiate a Phase 2 clinical study for ABI-5366 in mid-2026 and has begun Phase 2 enabling activities for ABI-1179. Assembly Bio's cash runway is projected to fund operations into late 2027, with potential extension beyond 2028.
Dec 8, 2025, 11:00 PM
Assembly Bio Announces Positive Phase I-B Results for Genital Herpes Candidates
ASMB
New Projects/Investments
Product Launch
  • Assembly Bio announced positive Phase I-B clinical study results for its long-acting helicase-primase inhibitor candidates, ABI-1179 and ABI-5366, in participants with recurrent genital herpes.
  • ABI-1179 (50 mg weekly) demonstrated a 98% reduction in HSV-2 shedding and a 91% reduction in virologically confirmed lesions compared to placebo.
  • ABI-5366 (350 mg weekly) showed a 94% reduction in HSV-2 shedding and a 97% reduction in virologically confirmed lesions compared to placebo.
  • While the monthly dosing cohort for ABI-5366 showed a 76% reduction in HSV-2 viral shedding, the company plans further optimization to maintain higher suppression levels.
  • Assembly Bio expects to initiate a Phase II clinical study of ABI-5366 in mid-2026 and has begun Phase II enabling activities for ABI-1179, with a cash runway funding the company into late 2027.
Dec 8, 2025, 11:00 PM
Assembly Biosciences Reports Positive Interim Phase 1b Results for HSV Candidates ABI-1179 and ABI-5366
ASMB
New Projects/Investments
Guidance Update
  • Assembly Biosciences, Inc. announced positive interim results from Phase 1b clinical studies of its investigational long-acting herpes simplex virus (HSV) helicase-primase inhibitor candidates, ABI-1179 and ABI-5366, for recurrent genital herpes.
  • The 50 mg weekly oral dose of ABI-1179 demonstrated a 98% reduction in HSV-2 shedding rate and a 91% reduction in virologically confirmed genital lesion rate compared to placebo.
  • The monthly oral dose of ABI-5366 showed a 76% reduction in HSV-2 shedding rate and an 88% reduction in virologically confirmed genital lesion rate compared to placebo.
  • The company plans to initiate Phase 2 clinical studies for once-weekly ABI-5366 regimens in mid-2026 and is evaluating advancing ABI-1179 into Phase 2 clinical evaluation.
Dec 8, 2025, 9:17 PM
Assembly Biosciences Reports Positive Interim Phase 1b Results for HSV Inhibitors
ASMB
New Projects/Investments
  • Assembly Biosciences announced positive interim results from two Phase 1b studies for its investigational long-acting herpes simplex virus (HSV) helicase-primase inhibitors, ABI-1179 and ABI-5366, on December 8, 2025.
  • The 50 mg weekly oral dose of ABI-1179 demonstrated a 98% reduction in HSV-2 shedding rate and a 91% reduction in virologically confirmed genital lesion rate.
  • The monthly oral dose of ABI-5366 showed a 76% reduction in HSV-2 shedding rate and an 88% reduction in virologically confirmed genital lesion rate.
  • Both ABI-1179 and ABI-5366 were observed to be well-tolerated in their respective studies. Assembly Bio plans to initiate longer-duration Phase 2 clinical studies for once-weekly ABI-5366 regimens in mid-2026 and is evaluating ABI-1179 for Phase 2 clinical evaluation.
  • Gilead Sciences, Inc. has the right to opt in for an exclusive license for further development and commercialization of the helicase-primase inhibitor program.
Dec 8, 2025, 9:05 PM
Assembly Biosciences Provides Update on Herpes Virus Pipeline and Financial Outlook
ASMB
New Projects/Investments
Guidance Update
  • Assembly Biosciences (ASMB) is now primarily focused on herpes virus treatments, with lead assets 5366 and 1179 for high recurrent genital herpes, both currently in phase 1b trials.
  • The company reported very positive interim data for 5366 in August, demonstrating over 90% reduction in shedding rate and greater than 90% reduction in lesions with once-a-week treatment, and the molecule has shown to be very well tolerated.
  • Upcoming data in December will include unblinded safety data for 5366, data for a monthly regimen of 5366, and initial data for 1179 from its phase 1b study.
  • The U.S. market for recurrent genital herpes is estimated at 1.3-1.4 million patients, with over 800,000 on chronic suppressive therapy, indicating a multi-billion dollar opportunity.
  • ASMB's cash position is just north of $230 million, providing a runway to the end of 2027, potentially beyond 2028 with Gilead contributions and opt-in decisions for HBV and HSV-2 programs.
Nov 12, 2025, 4:00 PM
Assembly Biosciences Reports Q3 2025 Financial Results and Positive Clinical Trial Updates
ASMB
Earnings
Guidance Update
New Projects/Investments
  • Assembly Biosciences reported a net loss of $9.2 million, or $0.72 per basic and diluted share, for the third quarter ended September 30, 2025, with revenue from collaborative research increasing to $10.8 million compared to $6.8 million in the same period of 2024.
  • The company's cash, cash equivalents, and marketable securities totaled $232.6 million as of September 30, 2025, an increase from $75.0 million as of June 30, 2025, largely due to $175 million in gross proceeds from equity financings. This cash position is projected to fund operations into late 2027.
  • Assembly Biosciences released positive interim Phase 1b results for ABI-5366 in recurrent genital herpes and interim Phase 1a results for ABI-6250 for HDV, supporting progression to Phase 2 clinical evaluation. Additional HSV program data readouts are anticipated by the end of the year.
Nov 10, 2025, 9:10 PM
Assembly Biosciences Presents Positive Phase 1b Data for ABI-4334
ASMB
New Projects/Investments
  • Assembly Biosciences announced positive Phase 1b clinical data for its next-generation investigational capsid assembly modulator ABI-4334 at The Liver Meeting® on November 7, 2025.
  • The study showed that ABI-4334 was well tolerated at both 150 mg and 400 mg oral doses given once-daily over 28 days in patients with chronic hepatitis B infection.
  • Treatment with ABI-4334 resulted in multi-log declines in hepatitis B virus (HBV) DNA and pregenomic RNA (pgRNA), indicating potent suppression of viral replication.
  • Gilead Sciences, Inc. has the right to opt in to an exclusive license for further development and commercialization of ABI-4334 after reviewing an option data package following completion of this Phase 1b study.
Nov 7, 2025, 1:00 PM
Assembly Biosciences Presents Positive Interim Phase 1b Data for ABI-5366
ASMB
New Projects/Investments
  • Assembly Biosciences announced on October 10, 2025, that interim Phase 1b clinical data for its long-acting herpes simplex virus (HSV) helicase-primase inhibitor candidate ABI-5366 were presented at the 38th Congress of the International Union Against Sexually Transmitted Infections (IUSTI)- Europe.
  • In the 350 mg weekly dosing cohort, ABI-5366 demonstrated statistically significant reductions compared to placebo, including a 94% decrease in HSV type 2 (HSV-2) shedding rate, a 98% decrease in high viral load shedding rate, and a 94% decrease in genital lesion rate.
  • ABI-5366 was observed to be well tolerated at both evaluated doses, and its pharmacokinetic profile supports weekly and potentially monthly dosing.
  • Assembly Bio expects to share further interim data for a monthly dosing regimen of ABI-5366 and for ABI-1179 (another HSV helicase-primase inhibitor candidate) later this fall, with Phase 2 clinical studies of ABI-5366 anticipated to begin in mid-2026.
  • Under a collaboration agreement, Gilead Sciences, Inc. has the right to opt in to an exclusive license for the helicase-primase inhibitor program after reviewing the option data package following completion of the Phase 1b studies.
Oct 10, 2025, 12:00 PM