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EPKINLY Trial Results Prompt Price Target Cut for Genmab (GMAB)
Yahoo Finance· 2026-01-30 07:07
Genmab A/S (NASDAQ:GMAB) ranks among the best high growth European stocks to buy. On January 20, H.C. Wainwright cut its price target for Genmab A/S (NASDAQ:GMAB) to $39 from $41, retaining a Buy rating on the company’s shares. The change comes after Genmab and partner AbbVie announced that their Phase 3 EPCORE DLBCL-1 trial found no meaningful improvement in the overall survival for EPKINLY (epcoritamab) monotherapy when compared to standard treatments in second-line diffuse large B-cell lymphoma (DLBCL) ...
Genmab Lymphoma Study Misses Key Target, Analyst Still Sees Upside
Benzinga· 2026-01-20 18:36
Core Insights - Genmab A/S released topline results from the Phase 3 EPCORE DLBCL-1 trial of epcoritamab for diffuse large B-cell lymphoma (DLBCL), comparing it to standard chemotherapy options [1][2]. Study Details - The global study enrolled 483 patients with at least one prior line of therapy who were ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT) [2]. - The trial began in January 2021 and is still ongoing [2]. Data Findings - The study showed an overall survival (OS) hazard ratio of 0.96, which did not reach statistical significance [3]. - Epcoritamab monotherapy demonstrated improvements in progression-free survival (PFS), complete response rate, duration of response, and time to next treatment [3]. Safety Profile - Adverse events observed in the study were consistent with the known safety profile of epcoritamab [4]. - Ongoing analysis will consider various factors, including the impact of the COVID-19 pandemic and the availability of new anti-lymphoma therapies [4]. Future Steps - Full trial results will be presented at a future medical meeting, and Genmab will engage with global regulatory authorities for next steps [5]. - Data from two additional Phase 3 trials evaluating fixed-duration epcoritamab for DLBCL is anticipated in 2026 [5]. - Epcoritamab is already approved as Epkinly in the U.S. and Japan, and as Tepkinly in the European Union [5]. Analyst Commentary - Analysts expressed concerns about the EPCORE DLBCL-1 trial's failure to achieve significant OS results, raising questions about the current r/r DLBCL indication's accelerated approval status [6]. - Confidence remains in the upcoming EPCORE DLBCL-2 trial results in 2026, supported by strong Phase 2 results with Epkinly plus R-CHOP [6]. - Analysts believe it is unlikely that Epkinly will lose its accelerated approval status, citing precedents with other drugs [7]. Market Reaction - Genmab shares were down 2.36% at $31.49 at the time of publication [8].
[Ad hoc announcement pursuant to Art. 53 LR] Roche continues strong momentum with 7% growth (CER) in the first half of 2025
GlobeNewswire News Room· 2025-07-24 05:00
Core Insights - Roche expects mid single-digit growth in Group sales and high single-digit growth in core earnings per share for 2025, along with an increase in dividends [1][4]. Financial Performance - Group sales for the first half of 2025 reached CHF 30.9 billion, a 7% increase at constant exchange rates (CER) and a 4% increase in CHF compared to 2024 [2][5]. - The Pharmaceuticals Division reported sales of CHF 24.0 billion, reflecting a 10% increase at CER and a 6% increase in CHF [6][16]. - The Diagnostics Division's sales remained stable at CHF 7.0 billion, showing a 3% decline in CHF [12][31]. - Core operating profit increased by 11% (6% in CHF) to CHF 12.0 billion, driven by higher sales and effective cost management [5][6]. - Core earnings per share rose by 12% (8% in CHF), while IFRS net income increased by 23% (17% in CHF) to CHF 7.8 billion [6][31]. Key Growth Drivers - The top five growth drivers in the Pharmaceuticals Division included Phesgo, Xolair, Hemlibra, Vabysmo, and Ocrevus, which collectively generated CHF 10.6 billion in sales, an increase of CHF 1.7 billion at CER compared to the first half of 2024 [7][9]. - Sales in the United States grew by 10%, driven by the continued growth of Xolair and the uptake of Hemlibra, Ocrevus, Vabysmo, and Phesgo [9][10]. - The International region saw a 14% increase in sales, led by Phesgo, Hemlibra, and Vabysmo, with China reporting a 9% increase [12][13]. Regulatory Approvals and Pipeline Developments - Roche received several important regulatory approvals, including US approval for Susvimo for diabetic retinopathy and EU approval for Itovebi for advanced breast cancer [3][15]. - Four potentially practice-changing therapies advanced into the final phase of clinical development, including NXT007 for haemophilia A and prasinezumab for early-stage Parkinson's disease [3][4]. - The introduction of the Elecsys PRO-C3 test aims to improve precision in evaluating liver fibrosis severity [22][19]. Strategic Collaborations - Roche announced a collaboration with Broad Clinical Labs to accelerate the adoption of SBX sequencing technology, focusing on genetic disorders in critically ill newborns [20][18].