分组1 - Assembly Biosciences reported quarterly earnings of $2.48 per share, significantly beating the Zacks Consensus Estimate of a loss of $0.51 per share, representing an earnings surprise of +586.28% [1] - The company posted revenues of $42.47 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 300.65%, compared to revenues of $7.36 million a year ago [2] - Over the last four quarters, Assembly Biosciences has surpassed consensus EPS estimates two times and topped consensus revenue estimates three times [2] 分组2 - The stock has underperformed the market, losing about 19.1% since the beginning of the year, while the S&P 500 has declined by 3.2% [3] - The current consensus EPS estimate for the coming quarter is -$0.50 on revenues of $10.6 million, and for the current fiscal year, it is -$4.10 on revenues of $32.2 million [7] - The Zacks Industry Rank for Medical - Generic Drugs is currently in the bottom 23% of over 250 Zacks industries, indicating potential challenges for stocks in this sector [8]

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UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from __________ to __________ Commission File Number: 001-35005 ASSEMBLY BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Inc ...

– 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 – Exhibit 99.1 Assembly Biosciences Reports Year-End 2025 Financial Results and Recent Highlights – 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, ...

– 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 devel ...

Core Insights - Gilead Sciences has exercised its option to exclusively license Assembly Biosciences' herpes simplex virus helicase-primase inhibitor programs, marking the first advancement under their collaboration [1][2] Licensing Agreement - Gilead entered a 12-year partnership with Assembly Biosciences in 2023 to develop novel antiviral therapies, with Assembly Bio receiving a $35 million payment upon Gilead's exercise of its option [2] - Gilead will obtain exclusive rights to ABI-5366 and ABI-1179, taking full responsibility for their clinical development and commercialization [2] Financial Milestones - Assembly Biosciences is eligible for up to $330 million in regulatory and commercial milestones, along with tiered royalties on net sales [3][7] Product Development - ABI-1179 and ABI-5366 are long-acting helicase-primase inhibitors showing strong antiviral activity and significant reduction in virus-positive lesions in interim data from early-stage studies [8][9] - Over four million people in the U.S. and some European countries suffer from recurrent genital herpes, indicating a substantial market opportunity for these new therapies [9][10] Market Context - No new HSV therapies have been approved in the U.S. or Europe in over 25 years, highlighting the potential impact of ABI-5366 and ABI-1179 if successfully developed [9][10] Gilead's HIV Portfolio - Gilead has a leading HIV franchise, with products like Biktarvy and Descovy driving top-line growth [11] - The recent FDA approval of lenacapavir for HIV prevention enhances Gilead's portfolio, especially as Truvada faces generic competition [12]

Core Insights - Biotechnology stocks experienced significant movements in after-hours trading, with several companies reporting strong gains driven by positive trial results and strategic announcements [1] Company Performances - Exicure, Inc. (XCUR) saw a substantial increase of 72.61% to $9.20 after announcing positive Phase 2 trial results for burixafor, achieving a primary endpoint success rate of approximately 90% in multiple myeloma patients [2] - Artiva Biotherapeutics, Inc. (ARTV) rose 10.39% to $3.40 despite a regular session decline, with no new updates reported [3] - iBio, Inc. (IBIO) advanced 8.38% to $1.81, following a significant 39.17% increase during regular trading [3] - Cartesian Therapeutics, Inc. (RNAC) increased by 6.55% to $7.16, recovering from a prior decline [4] - Metagenomi, Inc. (MGX) gained 7.18% to $1.94, with plans to present preclinical data at an upcoming conference [5] - BioAtla, Inc. (BCAB) rose 4.81% to $0.85, despite no new updates [6] - ProMIS Neurosciences, Inc. (PMN) climbed 3.02% to $7.85, following a publication related to Alzheimer's disease biomarkers [7] - DiaMedica Therapeutics Inc. (DMAC) increased by 4.77% to $9.18, with no new announcements [8] - Wave Life Sciences Ltd. (WVE) shares surged 4.97% to $19.44 after a significant 147.26% increase during regular trading, linked to a $250 million public offering [9] - Assembly Biosciences, Inc. (ASMB) gained 5.96% to $37.49, reporting positive interim results from Phase 1b studies of HSV inhibitors [10]

Core Insights - The company has reported impressive results from Phase Ib clinical studies of its long-acting helicase-primase inhibitor candidates, ABI-1179 and ABI-5366, for treating recurrent genital herpes [3]. Group 1: Clinical Study Results - Both ABI-1179 and ABI-5366 met or exceeded all key objectives of the study, indicating a significant advancement in treatment options for individuals with recurrent genital herpes [3]. - The data suggests a potential path to a best-in-class therapy, particularly in terms of dosing interval and improved efficacy compared to currently approved agents [3].

Summary of Assembly Biosciences Conference Call - December 08, 2025 Company Overview - **Company**: Assembly Biosciences (NasdaqGS: ASMB) - **Focus**: Development of long-acting helicase-primase inhibitors for the treatment of recurrent genital herpes Key Points Clinical Study Results - **Phase 1b Clinical Studies**: Results from two long-acting helicase-primase inhibitor candidates, ABI-1179 and ABI-5366, were presented, showing significant efficacy in reducing HSV-2 shedding and lesions in participants with recurrent genital herpes [2][3][4] - **ABI-5366 Results**: - 94% reduction in HSV-2 shedding and 97% reduction in virologically confirmed lesions in cohort B2 [3] - Monthly dosing cohort B3 showed potent antiviral activity but indicated the need for further optimization to maintain suppression levels [4][5] - **ABI-1179 Results**: - 98% reduction in HSV shedding and 92% reduction in lesions in cohort B1 [4][10] - Overall, ABI-1179 met or exceeded established goals with significant reductions in viral shedding and lesions compared to placebo [13] Safety and Tolerability - **Safety Profile**: Both ABI-1179 and ABI-5366 were well tolerated with no serious adverse events reported. Most treatment-emergent adverse events were Grade one or two [9][17] - **Adverse Events**: A single Grade three adverse event (migraine) was reported in ABI-1179, with no treatment discontinuations due to adverse events [9][17] Efficacy Metrics - **Efficacy Goals**: The target for the studies was an 80%-85% reduction in HSV-2 shedding, which was exceeded by both candidates [10][18] - **High Viral Load Shedding**: Near complete elimination of high viral load shedding was observed, with a greater than 99% reduction for the 50 mg dose of ABI-1179 [11][20] - **Virologically Confirmed Lesions**: For ABI-1179, a 91% reduction in lesions was noted for the 50 mg dose compared to placebo [12][21] Future Development Plans - **Next Steps**: Plans to initiate a phase 2 clinical study for ABI-5366 in mid-2026, with ongoing preparations for ABI-1179 [24][25] - **Collaboration with Gilead Sciences**: Gilead has the option to opt into an exclusive license for the HSV program, with ongoing discussions regarding the phase 1b datasets [25] Financial Position - **Cash Runway**: The company has a strong financial foundation, expecting to fund operations into late 2027, excluding potential future payments from collaborations [26] Market Potential - **Therapeutic Paradigm Shift**: Both ABI-5366 and ABI-1179 are believed to have the potential to change the treatment landscape for recurrent genital herpes, offering improved efficacy and convenience over current standard treatments [24][23] Additional Insights - **Formulation Optimization**: The company is exploring formulation tweaks to enhance exposure levels for ABI-5366, with a focus on long-term life cycle management [30][33] - **Regulatory Considerations**: Discussions with regulators will be necessary to incorporate high viral load shedding as a surrogate for transmission reduction in future studies [55][56] This summary encapsulates the critical findings and future directions for Assembly Biosciences as discussed in the conference call.

Interim Results from Phase 1b Clinical Studies of Long-Acting Helicase-Primase Inhibitor Candidates ABI-1179 and ABI-5366 in Recurrent Genital Herpes December 8, 2025 Nasdaq: ASMB ©2025 ASSEMBLY BIOSCIENCES, INC. Cautionary Note Regarding Forward-Looking Statements The information in this presentation contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to materially differ. These risks and uncertainties include: Assembly Bio's ability to re ...