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Genmab Announces Completion of Tender Offer for Outstanding Common Shares of Merus N.V. and Commencement of Subsequent Offering Period
Globenewswire· 2025-12-12 06:35
Core Insights - Genmab A/S has successfully completed the tender offer to acquire all outstanding common shares of Merus N.V. for $97 per share, marking a significant step in its strategy to transition to a wholly owned model and enhance revenue diversification [1][4] - The acquisition is expected to bolster Genmab's position as a global biotechnology leader, particularly through the integration of Merus' lead asset, petosemtamab, which is anticipated to have a substantial impact on head and neck cancer treatment [2][3] - Genmab projects that petosemtamab will contribute to EBITDA with an annual sales potential of at least $1 billion by 2029, with expectations for multi-billion-dollar revenue potential thereafter [3][8] Transaction Details - As of the expiration time on December 11, 2025, 71,463,077 shares of Merus, representing 94.2% of its outstanding shares, were validly tendered [4] - A subsequent offering period of ten business days has been initiated, allowing additional shares to be purchased at the same price of $97 per share [5] - Following the completion of the subsequent offering period, Genmab plans to finalize the acquisition of 100% of Merus through additional transactions [6] Strategic Fit - The addition of petosemtamab aligns with Genmab's expertise in antibody therapy development and commercialization in oncology, enhancing its late-stage pipeline [3][8] - Genmab aims to launch petosemtamab in 2027, contingent on clinical results and regulatory approvals, with plans for further development in other therapeutic areas [3]
Genmab A/S (GMAB) Discusses 2025 R&D Progress, ASH Data Review, and Strategic Pipeline Additions - Slideshow (NASDAQ:GMAB) 2025-12-11
Seeking Alpha· 2025-12-12 04:31
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Genmab A/S (GMAB) Discusses 2025 R&D Progress, ASH Data Review, and Strategic Pipeline Additions Transcript
Seeking Alpha· 2025-12-11 21:22
PresentationOperator Hello, and welcome to Genmab's ASH 2025 update. As a reminder, this webcast is being recorded. During this webcast, you may be presented with forward-looking statements that include words such as believes, anticipates, plans or expects. Actual results may differ materially, for example, as a result of delayed or unsuccessful development projects. Genmab is not under any obligation to update statements regarding the future nor to confirm such statements in relation to actual results, unl ...
Genmab (NasdaqGS:GMAB) 2025 R&D Day Transcript
2025-12-11 17:02
Summary of Genmab's ASH 2025 Update Company Overview - **Company**: Genmab - **Event**: ASH 2025 update and R&D review Key Highlights 1. **Strategic Acquisitions and Growth** - Genmab proposed the acquisition of Mirus and added Pathosentomab to its portfolio, positioning for sustained growth and long-term value creation [3][4] - The integration of Mirus is a key priority for 2026, with expectations for the transaction to close in Q1 2026 [4] 2. **Pipeline Developments** - Significant progress in the development of RINA-S, with three phase three trials and two phase two potentially registrational trials ongoing [5] - Epcoritamab has shown promising results in various lymphoma settings, with 31 abstracts accepted at ASH, including seven oral presentations [9][10] 3. **Epcoritamab Data** - In the EPCORE FL-1 study, the addition of epcoritamab to R squared resulted in a 79% risk reduction in progression or death, with a hazard ratio of 0.21 [17] - Overall response rate was 95% for the combination versus 79% for R squared alone, with a complete response rate of 83% compared to 50% [18] - The study demonstrated a significant improvement in duration of response, with a hazard ratio of 0.19 [19] 4. **Regulatory Approvals** - Epcoritamab received FDA approval for the treatment of follicular lymphoma after at least one line of therapy [25] - Ongoing global regulatory submissions are expected to be positively received [25] 5. **Future Expectations** - 2026 is anticipated to be a year of important catalysts, including multiple potential registrational data sets for EPCORE, RINA-S, and beta centromere [34] - Genmab aims to advance its evolution into a global biotech leader with a diversified, fully integrated model [35] Industry Context - **Oncology Market** - The oncology community is seeing a shift towards bispecific antibodies like epcoritamab, which offer off-the-shelf solutions and are easier to administer compared to CAR-T therapies [46] - Epcoritamab's subcutaneous administration and manageable safety profile are key differentiators for adoption in community settings [37] Additional Insights - **Safety and Tolerability** - Epcoritamab's safety profile showed manageable adverse events, with no severe cytokine release syndrome reported [21][22] - Proactive management of infections is emphasized, particularly in outpatient settings [23][40] - **Comparative Efficacy** - The discussion around sequencing CAR-T and bispecific therapies indicates that bispecifics may serve as effective bridging therapies before CAR-T cell collection [44] - The potential for improved overall survival with epcoritamab in comparison to existing therapies is a focal point for future studies [51] This summary encapsulates the key points from Genmab's ASH 2025 update, highlighting the company's strategic direction, pipeline advancements, and the evolving landscape of oncology treatments.
Genmab (NasdaqGS:GMAB) 2025 Earnings Call Presentation
2025-12-11 16:00
2025 R&D Update and ASH Data Review December 11, 2025 © Genmab 2025 This presentation contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. All statements other than statements of historical facts included in this presentation, including, without limitation, those regarding our financial position, business strategy, plans and objectives of management for future operations (including development plans ...
Genmab to Hold 2025 R&D Update and ASH Data Review Meeting
Globenewswire· 2025-12-11 07:00
Core Insights - Genmab A/S will hold its 2025 R&D Update and ASH Data Review Meeting virtually on December 11, 2025, at 11:00 AM Eastern Time, which can be accessed via live webcast [1] - The meeting is not part of the official ASH Annual Meeting program [2] Company Overview - Genmab is an international biotechnology company focused on improving patient lives through innovative antibody therapeutics, with over 25 years of experience in developing next-generation antibody technology platforms [3] - The company aims to transform the lives of individuals with cancer and other serious diseases by 2030 through its proprietary pipeline, which includes bispecific T-cell engagers and antibody-drug conjugates [3] - Established in 1999 and headquartered in Copenhagen, Denmark, Genmab has a global presence across North America, Europe, and Asia Pacific [4]
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Investors· 2025-12-09 19:57
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Genmab Announces New Data from Phase 1b/2 EPCORE® CLL-1 Highlighting Potential of Epcoritamab as Monotherapy and in Combination for Patients with Richter Transformation (RT)
Globenewswire· 2025-12-08 21:30
Media ReleaseCOPENHAGEN, Denmark; December 8, 2025 Two-year epcoritamab monotherapy data demonstrate high complete response and encouraging survival rates in patients with Richter transformation (RT), highlighting its potential as a treatment option for those unsuitable for chemotherapy Additional early data show promising efficacy of epcoritamab combination regimens in patients with RT Results underscore the potential of epcoritamab as a versatile therapy for a broad range of B-cell malignancies Genmab A/S ...
Genmab Presents Pivotal Phase 3 Data from EPCORE® FL-1 Trial Demonstrating Clinical Benefit of EPKINLY® (epcoritamab-bysp) in Combination with Rituximab and Lenalidomide (R2) in Patients with Relapsed or Refractory Follicular Lymphoma
Globenewswire· 2025-12-07 12:50
Core Insights - Genmab A/S announced positive results from the Phase 3 EPCORE® FL-1 study, demonstrating that the combination of EPKINLY® (epcoritamab) with rituximab and lenalidomide significantly reduces the risk of disease progression or death by 79% compared to standard care [2][3] - The overall response rate (ORR) for patients treated with EPKINLY + R2 was 95%, compared to 79% for those receiving R2 alone, indicating a substantial improvement in treatment efficacy [2][3] - The U.S. FDA has approved the EPKINLY + R2 combination for patients with relapsed or refractory follicular lymphoma after one or more lines of systemic therapy, marking a significant advancement in treatment options [4][5] Study Results - The EPCORE FL-1 study included patients with relapsed or refractory follicular lymphoma, showing that 83% of patients achieved a complete response (CR) with EPKINLY + R2, compared to 50% with R2 alone [3][5] - The duration of response (DOR) at 12 months was 89% for EPKINLY + R2 versus 49% for R2, highlighting the long-term benefits of the new treatment [3][5] - The safety profile of EPKINLY + R2 was consistent with known safety profiles, with 90.1% of patients experiencing Grade 3 or 4 treatment-emergent adverse events (TEAEs) [3][4] Industry Context - Follicular lymphoma is a common form of non-Hodgkin lymphoma, accounting for 20-30% of all NHL cases, with approximately 15,000 new diagnoses in the U.S. annually [7] - Current standard treatments are often ineffective over time, leading to relapses and shorter remission periods, which underscores the need for innovative therapies like EPKINLY [7] - Epcoritamab, developed using Genmab's DuoBody technology, is designed to target both T cells and B cells, enhancing the immune response against cancer cells [8][9] Future Developments - Genmab and AbbVie are continuing to explore the use of epcoritamab in various hematologic malignancies, with multiple ongoing Phase 3 trials assessing its efficacy as a monotherapy and in combination with other treatments [9] - The companies aim to expand regulatory approvals for epcoritamab in additional indications, including relapsed/refractory diffuse large B-cell lymphoma (DLBCL) [8][9] - Genmab's vision is to transform cancer treatment through innovative antibody medicines, with a focus on improving patient outcomes [10]
Genmab Announces Data From Multiple Clinical Trials Showing Treatment with Fixed-Duration Epcoritamab Led to Remissions in First-Line Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL)
Globenewswire· 2025-12-06 14:30
Core Insights - Genmab A/S announced updated results from two clinical trials evaluating epcoritamab-bysp for treating diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL), showing high overall response rates (ORR) and promising survival outcomes [2][8][11]. Trial Results Summary - In the EPCORE NHL-2 trial, Arm 8 demonstrated an ORR of 93% and a complete response (CR) rate of 86% in elderly patients with newly diagnosed DLBCL, with 79% of responders maintaining their response at two years [4][6]. - Arm 1 of the same trial showed an ORR of 98% and an 85% CR rate in patients with newly diagnosed DLBCL, with 74% of CRs ongoing after a median follow-up of 44.2 months [7][9]. - The EPCORE DLBCL-3 trial reported a 73% ORR and 62% CR rate in elderly patients unable to receive standard chemotherapy, with 54% progression-free and 65% alive at one year [3][14]. Safety Profile - Treatment-emergent adverse events (TEAEs) were consistent with previous studies, with Grade ≥3 infections occurring in 32% of patients, primarily in the first six cycles [5][10]. - Serious TEAEs included Grade 5 events, but no new serious infections were reported post-treatment [10][15]. Epcoritamab Overview - Epcoritamab is a bispecific antibody designed to engage T-cells and target B-cells, showing potential as a core therapy for various B-cell malignancies [23][24]. - The drug has received regulatory approval in certain lymphoma indications and is co-developed by Genmab and AbbVie [24][25]. Industry Context - DLBCL is the most common type of non-Hodgkin lymphoma, accounting for 25-30% of cases, with approximately 25,000 new cases diagnosed annually in the U.S. [17]. - Follicular lymphoma, accounting for 20-30% of NHL cases, is considered incurable with current therapies, highlighting the need for effective treatment options [18].