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Genmab Prunes Pipeline, Sharpens Focus On Late-Stage Cancer Assets
Benzinga· 2025-12-29 17:32
Core Viewpoint - Genmab A/S has decided to discontinue the clinical development of acasunlimab to focus on more promising late-stage opportunities in its portfolio [1][2]. Group 1: Clinical Development Decision - The decision to halt acasunlimab's development follows a thorough assessment of the competitive landscape and aims to concentrate resources on programs with the highest potential impact [1][2]. - Acasunlimab was involved in four cancer trials, including a Phase 3 study in non-small cell lung cancer and two Phase 2 trials in melanoma and non-small cell lung cancer [4]. Group 2: Financial Implications - The discontinuation of acasunlimab does not affect Genmab's full-year 2025 financial guidance [3]. - Analyst estimates previously modeled peak sales of approximately $300 million for acasunlimab, which was considered a minimal contribution to the company's overall revenue potential [5]. Group 3: Focus on Other Programs - Genmab will redirect its focus to other late-stage programs, including Epkinly (epcoritamab), petosemtamab, and rinatabart sesutecan (Rina-S), which are advancing in development [2]. - The combined peak sales potential for these three lead assets is estimated at $8 billion, indicating significant upside for Genmab [5]. Group 4: Market Reaction - Following the announcement, Genmab shares experienced a decline of 2.05%, trading at $32.73 [6].
Genmab Portfolio Prioritization Update
Globenewswire· 2025-12-29 13:10
Core Viewpoint - Genmab A/S has decided to discontinue the clinical development of acasunlimab to focus on higher-value opportunities in its late-stage pipeline, despite encouraging clinical data observed to date [1][2][7]. Group 1: Decision and Strategic Focus - The decision to halt the acasunlimab program is part of Genmab's strategic focus on maximizing value in its late-stage portfolio [1][7]. - Genmab will redirect resources towards programs with higher potential impact, specifically EPKINLY (epcoritamab), petosemtamab, and rinatabart sesutecan (Rina-S), which are currently in late-stage development [1][2]. Group 2: Financial Guidance - This decision will not affect Genmab's full-year 2025 financial guidance, indicating stability in the company's financial outlook despite the program discontinuation [3][7]. Group 3: Company Background - Genmab is an international biotechnology company focused on developing innovative antibody medicines for cancer and other serious diseases, with over 25 years of experience in advancing various antibody-based therapeutic formats [4][5]. - The company has a strong late-stage clinical pipeline and aims to deliver transformative medicines to patients [4].
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]
Merus and Halozyme Enter Global Collaboration and License Agreement to Develop Subcutaneous Formulation of Petosemtamab
Prnewswire· 2025-11-17 12:00
Core Insights - Merus N.V. and Halozyme Therapeutics, Inc. have entered into a global non-exclusive collaboration and license agreement to develop and potentially commercialize the subcutaneous administration of petosemtamab, an EGFR x LGR5 bispecific antibody [1][2][3] Company Overview - Halozyme is a biopharmaceutical company known for its ENHANZE drug delivery technology, which facilitates subcutaneous delivery of injected drugs, aiming to improve patient experience and treatment efficiency [4][5] - Merus specializes in developing innovative full-length multispecific antibodies and antibody drug conjugates, referred to as Multiclonics, which have shown promising results in clinical studies [7][8] Collaboration Details - Under the agreement, Merus will make an upfront payment to Halozyme, along with potential future milestone payments based on commercial and sales achievements, if approved [3] - Halozyme is entitled to receive low to mid-single digit royalties on net sales of petosemtamab formulated with the ENHANZE technology during the royalty term [3] Clinical Potential - Petosemtamab has shown encouraging results in clinical studies across various solid tumor cancers and is positioned to potentially become a first and best-in-class treatment for head and neck cancer and other indications [2][3]
Genmab Announces Financial Results for the Nine Months of 2025
Globenewswire· 2025-11-06 16:02
Core Insights - Genmab has made significant advancements in its late-stage portfolio, with Epcoritamab nearing availability for earlier treatment lines in follicular lymphoma and Rina-S receiving Breakthrough Therapy Designation for advanced endometrial cancer [2][6] - The proposed acquisition of Merus is expected to enhance Genmab's late-stage pipeline by adding petosemtamab, which has two Breakthrough Therapy Designations, and is anticipated to drive sustained growth into the next decade [2][8] Financial Performance - Genmab's revenue for the first nine months of 2025 reached $2,662 million, a 21% increase from $2,198 million in the same period of 2024, primarily driven by higher royalties from DARZALEX and Kesimpta, as well as increased net product sales of EPKINLY [6][7] - Royalty revenue increased to $2,219 million in the first nine months of 2025, up from $1,802 million in the same period of 2024, marking a 23% rise [7] - Operating profit for the first nine months of 2025 was $1,007 million, compared to $662 million in the same period of 2024 [7] Strategic Outlook - Genmab is maintaining its financial guidance for 2025 as published on August 7, 2025 [4] - The company has transitioned its functional and presentation currency from DKK to USD effective January 1, 2025, with retrospective adjustments made to prior periods [5] Acquisition Details - Genmab intends to acquire Merus for $97.00 per share in an all-cash transaction valued at approximately $8.0 billion, funded through cash on hand and $5.5 billion of non-convertible debt financing [8] - The acquisition is expected to close by early Q1 2026, subject to customary closing conditions [8]
Merus' Interim Data on Petosemtamab in Metastatic Colorectal Cancer Demonstrates Monotherapy Activity and Robust Response Rate in Combination with FOLFOX/FOLFIRI with Well Tolerated Safety
Globenewswire· 2025-10-24 14:00
Core Insights - Merus N.V. announced interim clinical data for petosemtamab, a bispecific antibody, showing promising response rates in metastatic colorectal cancer (mCRC) patients [1][2][3] Group 1: Clinical Data Summary - In the ongoing phase 2 trial, petosemtamab demonstrated a 100% response rate in first-line (1L) left-sided mCRC patients (n=8) and a 62% response rate in second-line (2L) mCRC patients (n=13) [1][3] - The trial included 54 patients with left- and/or right-sided, KRAS, NRAS, and BRAF wildtype microsatellite stable mCRC, treated with petosemtamab in combination with FOLFOX/FOLFIRI or as monotherapy [3] - In the 1L treatment group, 10 patients were efficacy evaluable, with 8 left-sided patients showing an 80% response rate, including 1 confirmed complete response and 7 partial responses [3][7] Group 2: Mechanism of Action and Potential Impact - Petosemtamab targets both EGFR and LGR5, which may provide a new treatment option for patients with EGFR inhibitor-naïve mCRC [2] - The early results suggest that petosemtamab could become a transformational treatment and a new standard of care for various solid tumors [2] Group 3: Safety Profile - The safety profile of petosemtamab in mCRC appears consistent with its established profile in recurrent/metastatic head and neck squamous cell carcinoma, with no significant overlapping toxicities identified [7] - Infusion-related reactions were managed effectively, with no discontinuations due to these reactions [7]
Merus Announces Publication of an Abstract on Petosemtamab in Metastatic Colorectal Cancer at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
Globenewswire· 2025-10-14 11:30
Core Insights - The article discusses the promising interim clinical data for petosemtamab, a bispecific antibody, in combination with standard chemotherapy regimens FOLFOX/FOLFIRI for metastatic colorectal cancer (mCRC) and as a monotherapy for later lines of treatment [1][2] Clinical Trial Data - As of April 28, 2025, 36 patients with microsatellite stable mCRC received petosemtamab 1500 mg Q2W, either in combination with FOLFOX/FOLFIRI or as monotherapy [2] - In the 1L treatment group, 7 patients were treated, with 3 being efficacy evaluable, showing 1 unconfirmed complete response and 2 partial responses [2] - In the 2L treatment group, 10 patients were treated, with 8 being efficacy evaluable, resulting in 4 partial responses and 3 stable diseases [2] - In the 3L+ monotherapy group, 19 patients were treated, with 14 being efficacy evaluable, showing 1 unconfirmed partial response and 6 stable diseases [2] Safety Profile - No fatal treatment-related adverse events (TEAEs) were observed across all cohorts [2] - Common TEAEs for petosemtamab plus FOLFOX included dermatitis acneiform (71%), constipation (43%), fatigue (43%), and peripheral neuropathy (43%) [2] - Common TEAEs for petosemtamab plus FOLFIRI included diarrhea (70%), mucosal inflammation (50%), and fatigue (40%) [2] - For petosemtamab monotherapy, frequent TEAEs included rash (58%) and nausea (26%) [7] Upcoming Presentations - The updated clinical data will be presented in a plenary session on October 24, 2025, at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics [3]
GMAB Stock Soars 21.9% in a Month Following MRUS Acquisition Deal
ZACKS· 2025-10-06 14:51
Core Insights - Genmab A/S (GMAB) shares have increased by 21.9% over the past month following the announcement of its acquisition of Merus N.V. (MRUS) for $97 per share, totaling approximately $8 billion [1][6] - The acquisition price represents a 41% premium over Merus' closing price of $68.89 on September 26, 2025, with the deal expected to close in early Q1 2026, pending customary conditions [2][3] Company Strategy - The acquisition of Merus signifies Genmab's strategic transition from a licensing-based model to a fully owned business framework, aimed at diversifying its revenue streams [3] - The addition of petosemtamab, Merus' lead late-stage oncology candidate, enhances Genmab's proprietary pipeline and aligns with its expertise in antibody therapy development [4][6] Growth Potential - Genmab anticipates multiple new drug launches by 2027 across various oncology indications, bolstering its long-term growth prospects [4] - Petosemtamab is projected to contribute at least $1 billion in annual sales by 2029, with potential for multi-billion-dollar revenue growth in subsequent years [10] Clinical Development - Petosemtamab is currently being evaluated in two phase III studies for head and neck cancer, with interim results expected in 2026 [9] - The candidate has received two Breakthrough Therapy designations from the FDA, indicating its potential as a first-in-class therapy for head and neck cancer [8]
Why Genmab Stock Popped on Friday
The Motley Fool· 2025-10-03 21:29
Core Viewpoint - Analysts have raised their price targets for Genmab following the company's acquisition of Merus for $8 billion, leading to a significant increase in the stock price [1][2]. Group 1: Analyst Upgrades - Two analysts increased their price targets for Genmab, contributing to a more than 4% rise in the company's shares [1]. - H.C. Wainwright's Raghuram Selvaraju raised his price target from $36 to $40 per share while maintaining a buy recommendation [2]. - Truist Securities' Asthika Goonewardene raised his price target from $46 to $49 per share, citing similar reasons for the upgrade [4]. Group 2: Acquisition Details - Genmab announced the acquisition of Dutch peer Merus, valued at $8 billion, which is a key factor in the analysts' positive outlook [2]. - The acquisition includes petosemtamab, an investigational cancer drug that has shown solid performance in clinical trials and is in the later stages of development [3]. Group 3: Future Expectations - Analysts expect results from petosemtamab's clinical trials to be available soon, with potential readouts as early as next year [4].
Why Genmab Stock Was Marching Higher Today
Yahoo Finance· 2025-09-30 19:43
Core Insights - Genmab, a Denmark-based biotech company, announced a significant acquisition of Merus for $8 billion, paying $97 per share in cash, which has been positively received by analysts and the market [2][3] Group 1: Acquisition Details - The acquisition of Merus is expected to close in the first calendar quarter of 2026 and is seen as a strategic move to accelerate Genmab's transition to a wholly owned model, diversifying revenue and driving growth [2][3] - Analysts view the acquisition as beneficial, particularly highlighting the attractive price for Merus's late-stage cancer drug, petosemtamab [3] Group 2: Analyst Reactions - Truist Securities analyst Asthika Goonewardene reiterated a buy recommendation for Genmab with a price target of $46 per share [3] - TD Cowen's Yaron Werber raised his price target for Genmab from $24 to $32 per share, maintaining a hold recommendation, indicating a more cautious outlook [4] Group 3: Market Performance - Following the acquisition announcement, Genmab's stock rose nearly 5%, significantly outperforming the S&P 500, which only saw a marginal increase of 0.1% [1]