ASMB

SOUTH SAN FRANCISCO, Calif. (AP) — SOUTH SAN FRANCISCO, Calif. (AP) — Assembly Biosciences Inc. (ASMB) on Thursday reported a loss of $9.1 million in its first quarter. On a per-share basis, the South San Francisco, California-based company said it had a loss of 54 cents. The biotech drug developer posted revenue of $8.2 million in the period. Assembly Biosciences shares have decreased slightly more than 8% since the beginning of the year. In the final minutes of trading on Thursday, shares hit $31.19, more than doubling in the last 12 months. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on ASMB at https://www.zacks.com/ap/ASMB

– Completed Phase 1b studies for ABI-5366 and ABI-1179, helicase-primase inhibitors for recurrent genital herpes – – Completed chronic toxicology studies for ABI-6250, an oral small-molecule entry inhibitor candidate for chronic hepatitis delta virus; Phase 2 initiation anticipated Q4 2026 – SOUTH SAN FRANCISCO, Calif., May 07, 2026 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today reported financial results for the first quarter ended March 31, 2026, and recent highlights. “The first quarter reflected steady progress across our portfolio as we continue advancing our discovery and development programs,” said Jason Okazaki, chief executive officer and president of Assembly Bio. “As we look ahead, we anticipate receiving Gilead’s development plan and budget for the herpesvirus program and will evaluate our cost and profit share opt-in decision by mid-2026 while continuing to advance ABI-6250 toward Phase 2 in hepatitis delta virus by year-end.” First Quarter 2026 and Recent Highlights Completed follow-up period for all participants in the Phase 1b portion of the studies for ABI-5366 and ABI-1179, reinforcing continued confidence in the safety and efficacy findings previously disclosed for both candidates Completed chronic toxicology studies for ABI-6250, establishing support for anticipated phase 2 doses Presented an oral presentation and three posters, including one late-breaker, highlighting interim Phase 1b data for ABI-5366 and ABI-1179 at the 2026 Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in Munich, Germany Anticipated Milestones and Events By mid-2026, upon receipt of Gilead Sciences, Inc. (Gilead)’s development plan and budget for the helicase-primase inhibitor (HPI) program (ABI-5366 and ABI-1179) for recurrent genital herpes, Assembly Bio to determine whether to opt in to a 40% U.S. cost-profit share, in lieu of receiving U.S. milestones and royalties Initiation of a Phase 2 clinical study for ABI-6250 in participants with chronic hepatitis delta virus (HDV) infection expected in the fourth quarter of 2026 Upcoming Conferences European Association for the Study of the Liver (EASL) Congress: May 27-30, 2026 – Barcelona, Spain ABI-5366, ABI-1179 and ABI-6250 are investigational product candidate...

Assembly Biosciences (ASMB) came out with quarterly earnings of $2.48 per share, beating the Zacks Consensus Estimate of a loss of $0.51 per share. This compares to a loss of $1.57 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +586.28%. A quarter ago, it was expected that this biotech drug developer would post a loss of $0.5 per share when it actually produced a loss of $0.72, delivering a surprise of -44%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Assembly Biosciences, which belongs to the Zacks Medical - Generic Drugs industry, posted revenues of $42.47 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 300.65%. This compares to year-ago revenues of $7.36 million. The company has topped consensus revenue estimates three times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Assembly Biosciences shares have lost about 19.1% since the beginning of the year versus the S&P 500's decline of 3.2%. While Assembly Biosciences has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Assembly Biosciences was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near futur...

– Successfully licensed helicase-primase inhibitor program for recurrent genital herpes to Gilead, including candidates ABI-5366 and ABI-1179, following positive Phase 1b interim data; development plan anticipated by mid-2026 – – Phase 2 initiation for ABI-6250, an oral small-molecule entry inhibitor candidate for chronic hepatitis delta virus, anticipated by end of 2026 – SOUTH SAN FRANCISCO, Calif., March 19, 2026 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today reported financial results for the year ended December 31, 2025, and recent highlights. “2025 was a pivotal year for the Company, and we anticipate another strong year ahead,” said Jason Okazaki, chief executive officer and president of Assembly Bio. “Compelling Phase 1b data across ABI-5366 and ABI-1179 led to an early decision by Gilead to license the HPI program, validating the strength of our science and execution, as well as the potential for our long-acting, oral antivirals to meaningfully improve patient care. As we enter 2026, we are well positioned – both scientifically and financially – to build on this momentum as we continue advancing our broader pipeline.” Fourth Quarter 2025 and Recent Highlights Recurrent genital herpes Released positive interim Phase 1b data from two weekly dose cohorts of ABI-1179 and additional interim data from the ABI-5366 Phase 1b study, including unblinded safety data from two weekly cohorts released in August 2025 and a monthly oral proof-of-concept cohort Licensed helicase-primase inhibitor (HPI) program, including ABI-5366 and ABI-1179, to Gilead Sciences, Inc. (Gilead), receiving a net $35 million option fee under the ongoing collaboration agreement Completed dosing and follow-up for all participants in Phase 1a/b studies for ABI-5366 and ABI-1179 Viral hepatitis Gilead declined to exercise or defer its option on ABI-4334, a highly potent capsid assembly modulator candidate for chronic hepatitis B virus (HBV) infection Initiated a structured process to find a partner for ABI-4334 after regaining sole rights to the program Scientific conference presentations highlighted Presented interim Phase 1b data for ABI-5366 in a late-breaking oral presentation at the 38th Congress of the International Union Against Sexually Transmitted Infections (IUSTI)-E...

SOUTH SAN FRANCISCO, Calif. (AP) — SOUTH SAN FRANCISCO, Calif. (AP) — Assembly Biosciences Inc. (ASMB) on Thursday reported fourth-quarter net income of $22.1 million, after reporting a loss in the same period a year earlier. On a per-share basis, the South San Francisco, California-based company said it had profit of $2.48. The biotech drug developer posted revenue of $42.5 million in the period. For the year, the company reported that its loss narrowed to $6.1 million, or 55 cents per share. Revenue was reported as $72.3 million. Assembly Biosciences shares have dropped 19% since the beginning of the year. In the final minutes of trading on Thursday, shares hit $27.51, more than doubling in the last 12 months. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on ASMB at https://www.zacks.com/ap/ASMB

Supernus Pharmaceuticals (SUPN) came out with quarterly earnings of $0.92 per share, beating the Zacks Consensus Estimate of $0.28 per share. This compares to earnings of $0.75 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +228.57%. A quarter ago, it was expected that this drugmaker would post earnings of $0.82 per share when it actually produced earnings of $1.01, delivering a surprise of +23.17%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Supernus, which belongs to the Zacks Medical - Generic Drugs industry, posted revenues of $211.57 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 7.57%. This compares to year-ago revenues of $174.16 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Supernus shares have added about 2% since the beginning of the year versus the S&P 500's decline of 0.1%. While Supernus has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Supernus was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #5 (Strong Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Ra...

– 98% reduction in HSV-2 shedding rate, >99% reduction in high viral load shedding rate and 91% reduction in virologically confirmed genital lesion rate observed in 50 mg weekly oral dose of ABI-1179, exceeding expectations for the study – – 76% reduction in HSV-2 shedding rate, 81% reduction in high viral load shedding rate and 88% reduction in virologically confirmed genital lesion rate observed in proof-of-concept test of monthly oral dose of ABI-5366 – – Company to hold conference call today at 6 p.m. ET – SOUTH SAN FRANCISCO, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today announced positive interim results from two Phase 1b studies of its investigational long-acting herpes simplex virus (HSV) helicase-primase inhibitors in participants seropositive for HSV type 2 (HSV-2) with recurrent genital herpes. These interim results include the first reported Phase 1b data for ABI-1179, evaluating weekly oral dosing. For ABI-5366, the reported data is for a monthly oral dosing regimen, following the positive interim results for weekly oral dosing reported earlier this year. “As we saw with ABI-5366, weekly oral dosing of ABI-1179 outperformed our expectations for antiviral efficacy and improvement in clinical outcomes, and we are thrilled with these Phase 1b findings for both highly promising candidates,” said Anuj Gaggar, MD, PhD, chief medical officer of Assembly Bio. “The ABI-5366 monthly oral dosing results are also encouraging and show significant reductions in viral shedding and virologically confirmed genital lesion rate, supporting the continued optimization of exposure to evaluate its potential for monthly oral dosing. We expect to pursue such optimization efforts in parallel with moving once-weekly ABI-5366 regimens into longer-duration Phase 2 clinical studies, which we plan to initiate in mid-2026. In parallel, we are evaluating the potential to also advance ABI-1179 into Phase 2 clinical evaluation and are progressing Phase 2 enabling activities for this candidate.” In the ABI-1179 study, highly potent antiviral activity was observed with a 98% reduction in HSV-2 shedding rate compared to placebo (p<0.01) over the 29-day evaluation period in the 50 mg weekly dose cohort. This reduction exceeds Assembly Bio’s target...

SOUTH SAN FRANCISCO, Calif. (AP) — SOUTH SAN FRANCISCO, Calif. (AP) — Assembly Biosciences Inc. (ASMB) on Monday reported a loss of $9.2 million in its third quarter. On a per-share basis, the South San Francisco, California-based company said it had a loss of 72 cents. The biotech drug developer posted revenue of $10.8 million in the period. Assembly Biosciences shares have more than doubled since the beginning of the year. In the final minutes of trading on Monday, shares hit $32.02, a rise of 91% in the last 12 months. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on ASMB at https://www.zacks.com/ap/ASMB

– Released positive Phase 1b interim results for long-acting helicase-primase inhibitor candidate ABI-5366 showing significant reductions in viral shedding rate and genital lesion rate in recurrent genital herpes – – Announced Phase 1a interim results for orally bioavailable HDV entry inhibitor candidate ABI-6250 supporting progression into Phase 2 evaluation – – Additional interim Phase 1b data readouts from HSV program anticipated to include monthly oral dosing for ABI-5366 and two cohorts of weekly oral dosing for ABI-1179, with data now expected by end of year – – Raised $175 million gross proceeds from equity financings – SOUTH SAN FRANCISCO, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today reported financial results and recent updates for the third quarter ended September 30, 2025. “Our third quarter was marked by significant progress across our pipeline and important data releases, particularly the impressive interim antiviral activity and clinical outcomes data from our Phase 1b study for ABI-5366 in participants with recurrent genital herpes,” said Jason Okazaki, chief executive officer and president of Assembly Bio. “The $175 million equity investment we completed in August enables us to advance both our HSV and HDV programs into Phase 2 while continuing our efforts to discover and develop new programs. With enrollment in our Phase 1b study for ABI-5366 and two cohorts in our Phase 1b study for ABI-1179 now complete, we look forward to sharing additional data updates from our HSV program later this year.” Third Quarter 2025 and Recent Highlights Herpes Simplex Virus (HSV) Released positive interim results from a Phase 1b study of ABI-5366, a long-acting helicase-primase inhibitor development candidate, demonstrating significant reductions in HSV type 2 (HSV-2) shedding rate, high viral load shedding and genital lesion rates in participants with recurrent genital herpes Completed enrollment in the ongoing Phase 1b study of ABI-5366 in participants with recurrent genital herpes Completed enrollment in two cohorts of the ongoing Phase 1b study in participants with recurrent genital herpes for ABI-1179, a second long-acting helicase-primase inhibitor development candidate Presented interim Phase 1b data for ABI-5366 in...

– 94% reduction in HSV-2 shedding rate and 98% reduction in high viral load shedding rate, both statistically significant, observed in cohort evaluating 350 mg weekly oral dose compared to placebo over 29-day evaluation period – – 94% reduction in genital lesion rate, also statistically significant, observed with 350 mg weekly oral dose compared to placebo over same period – – Favorable safety and tolerability profile observed in the first two cohorts evaluating weekly oral doses of ABI-5366 – SOUTH SAN FRANCISCO, Calif., Aug. 08, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today announced positive interim antiviral activity, clinical outcomes, safety and pharmacokinetic (PK) results from a Phase 1b study evaluating ABI-5366, an investigational long-acting herpes simplex virus (HSV) helicase-primase inhibitor, in participants seropositive for HSV type 2 (HSV-2) with recurrent genital herpes. For the powered antiviral endpoint, HSV-2 shedding rate, highly potent antiviral activity was observed with a 94% reduction compared to placebo (p<0.01) over the 29-day evaluation period in the cohort evaluating a 350 mg weekly dose. This reduction exceeds Assembly Bio’s target for the study of an 80%-85% reduction in the rate of HSV-2 shedding. For a secondary clinical endpoint of genital lesion rate, a 94% reduction compared to placebo (p<0.01) was observed with the 350 mg weekly dose. The rate of samples with high viral load (i.e., >104 copies/mL HSV DNA), a potential surrogate for HSV-2 transmission and a secondary endpoint, was reduced by 98% compared to placebo (p<0.05) in this cohort. ABI-5366 was observed to be well-tolerated at oral doses up to 350 mg weekly in participants seropositive for HSV-2 with recurrent genital herpes. The observed PK profile continues to support once-weekly dosing and the potential for once-monthly oral dosing regimens. With these data, Assembly Bio expects to move directly into Phase 2 clinical study preparation in parallel with completion of this Phase 1b study, which includes an ongoing cohort evaluating a monthly oral dosing regimen. The in-life portions of chronic toxicology studies of ABI-5366 are now complete and these studies are expected to support longer-term dosing in Phase 2. “We are thrilled to see these inte...

– On track for proof-of-concept Phase 1b data no later than this fall in participants with recurrent genital herpes for long-acting herpes simplex virus (HSV) helicase-primase inhibitor candidates, ABI-5366 and ABI-1179 – – Positive topline data reported for Phase 1b study of ABI-4334, a next-generation highly potent capsid assembly modulator candidate, in participants with chronic hepatitis B virus (HBV) – – Interim data, including a biomarker for target engagement, reported from Phase 1a study in healthy volunteers of ABI-6250, an orally bioavailable, small molecule viral entry inhibitor candidate in development for chronic hepatitis delta virus (HDV) – SOUTH SAN FRANCISCO, Calif., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today reported financial results and recent updates for the second quarter ended June 30, 2025. “We are advancing toward our goal of generating impactful clinical datasets for four development candidates in 2025,” said Jason Okazaki, chief executive officer and president of Assembly Bio. “We have delivered two important datasets already this year from our hepatitis programs, including positive topline data from our Phase 1b study of our most potent capsid assembly modulator, ABI-4334, in participants with chronic HBV, as well as interim data from a Phase 1a study of ABI-6250, including biomarker data supporting target engagement. Looking ahead, we remain on track to report key proof-of-concept Phase 1b data, including antiviral activity, no later than fall for ABI-5366 and ABI-1179 in participants with recurrent genital herpes, a chronic viral infection that significantly impacts the lives of millions of individuals.” Second Quarter 2025 and Recent Highlights Initiated dosing in the Phase 1b portion of the ongoing Phase 1a/b trial for ABI-1179 and received clearance for an Investigational New Drug application to support expansion of this study to sites in the United States Released positive topline Phase 1b results for ABI-4334 that met Assembly Bio’s target clinical profile for the study, including strong antiviral activity in participants with chronic HBV infection Shared interim data from a Phase 1a study of ABI-6250 in healthy volunteers, including pharmacokinetics (PK) supportive of a once-daily oral dosing...

SOUTH SAN FRANCISCO, Calif. (AP) — SOUTH SAN FRANCISCO, Calif. (AP) — Assembly Biosciences Inc. (ASMB) on Wednesday reported a loss of $10.2 million in its second quarter. On a per-share basis, the South San Francisco, California-based company said it had a loss of $1.33. The biotech drug developer posted revenue of $9.6 million in the period. Assembly Biosciences shares have climbed 23% since the beginning of the year. In the final minutes of trading on Wednesday, shares hit $19.43, a rise of 45% in the last 12 months. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on ASMB at https://www.zacks.com/ap/ASMB