Latest news with #Epcoritamab
Yahoo
07-08-2025
- Business
- Yahoo
Genmab Announces Phase 3 EPCORE® FL-1 Clinical Trial Met Dual Primary Endpoints in Patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL)
Epcoritamab in combination with rituximab and lenalidomide (R2) demonstrated statistically significant improvement in Overall Response Rate (ORR; 95.7%, p < 0.0001) and Progression-Free Survival (HR 0.21, p-value <0.0001) versus R2 alone in patients with relapsed/refractory (R/R) Follicular Lymphoma (FL) Results from EPCORE FL-1 form the basis of global regulatory submissions U.S. FDA has accepted for priority review new supplemental Biologics License Application (sBLA) for epcoritamab plus R2, with action date of November 30, 2025 If approved, epcoritamab plus R2 would be the first bispecific antibody combination regimen available as a second-line treatment option for patients with R/R FL COPENHAGEN, Denmark, August 07, 2025--(BUSINESS WIRE)--Genmab A/S (Nasdaq: GMAB) today announced positive results of the Phase 3 EPCORE® FL-1 trial evaluating subcutaneous epcoritamab, a bispecific antibody, in combination with rituximab and lenalidomide (R2) versus R2 alone for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The study met its dual primary endpoints of overall response rate (ORR, p-value < 0.0001) and progression-free survival (PFS, HR 0.21, p-value <0.0001), demonstrating statistically significant and clinically meaningful differences in both endpoints, reducing the risk of disease progression or death by 79%. The results, derived from a pre-planned interim analysis, will be submitted for presentation at the 67th Annual Meeting and Exposition of the American Society of Hematology (ASH) and will serve as the basis for global regulatory submissions. Separately, on July 24, the U.S. Food and Drug Administration (FDA) accepted for priority review the supplemental Biologics License Application (sBLA) for epcoritamab plus R2 following at least one prior systemic therapy. The sBLA submission was based on data from a first interim analysis that demonstrated statistically significant improvements in ORR (95.7%, p-value < 0.0001) and PFS (HR 0.21, p-value <0.0001, based on the intent-to-treat population). Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of November 30, 2025. If approved, epcoritamab plus R2 would be the first bispecific antibody combination regimen available in the U.S. as a second-line treatment option for patients with R/R FL. "While therapeutic options exist for patients with relapsed or refractory follicular lymphoma, response rates tend to decline and durability diminishes with each subsequent line of treatment, which can increase the risk of the disease transforming into aggressive large-cell lymphoma," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "The results from this trial, and the decision from the FDA to accept the sBLA for priority review, demonstrate the potential of this epcoritamab combination therapy to reshape the treatment landscape and reinforces our shared commitment with AbbVie to advance epcoritamab as a potential core therapy across B-cell malignancies." The safety profile of epcoritamab in combination with R2 in adult patients with R/R FL was consistent with the known safety profiles of the individual regimens (epcoritamab and R2) and as presented in the U.S. prescribing information for epcoritamab. No new safety signals were observed. The U.S. FDA has granted accelerated approval of single agent epcoritamab for the treatment of adults with R/R FL after two or more lines of systemic therapy. The U.S. FDA also granted Breakthrough Therapy Designation (BTD) to epcoritamab in combination with R2 for the treatment of adult patients with R/R FL who have received at least one prior line of therapy. The safety and efficacy of epcoritamab in combination with R2 in R/R FL is currently being evaluated in clinical trials and is not approved or established in the U.S., EU or in any other territory. About Follicular Lymphoma (FL) FL is typically an indolent (or slow-growing) form of non-Hodgkin's lymphoma (NHL) that arises from B-lymphocytes and is the second most common form of NHL accounting for 20-30 percent of all cases.i About 15,000 people develop FL each year in the and it is considered incurable with current standard of care Patients often relapse and, with each relapse the remission and time to next treatment is Over time, transformation to diffuse large B-cell lymphoma (DLBCL), an aggressive form of NHL associated with poor survival outcomes, can occur in more than 25 percent of FL patients.v About the EPCORE FL-1 Trial EPCORE FL-1 (NCT05409066) is a Phase 3 open-label interventional trial to evaluate the safety and efficacy of epcoritamab plus rituximab and lenalidomide (R2) versus R2 alone in patients with relapsed/refractory (R/R) follicular lymphoma (FL). The dual primary endpoints are ORR and PFS assessed by independent review committee (IRC) per Lugano criteria. About Epcoritamab Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody® technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ Epcoritamab (approved under the brand name EPKINLY® in the U.S. and Japan, and TEPKINLY® in the EU) has received regulatory approval in certain lymphoma indications in several territories. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication. Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes five ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (NCT04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with R/R FL (NCT05409066), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744), and a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit for more information. EPKINLY® (epcoritamab-bysp) U.S. INDICATIONS & IMPORTANT SAFETY INFORMATION What is EPKINLY? EPKINLY is a prescription medicine used to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, or follicular lymphoma (FL) that has come back or that did not respond to previous treatment after receiving 2 or more treatments. EPKINLY is approved based on patient response data. Studies are ongoing to confirm the clinical benefit of EPKINLY. It is not known if EPKINLY is safe and effective in children. IMPORTANT SAFETY INFORMATION Important Warnings—EPKINLY can cause serious side effects, including: Cytokine release syndrome (CRS), which is common during treatment with EPKINLY and can be serious or life-threatening. To help reduce your risk of CRS, you will receive EPKINLY on a step-up dosing schedule (when you receive 2 or 3 smaller step-up doses of EPKINLY before your first full dose during your first cycle of treatment), and you may also receive other medicines before and for 3 days after receiving EPKINLY. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule. Neurologic problems that can be serious, and can be life-threatening and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY. People with DLBCL or high-grade B-cell lymphoma should be hospitalized for 24 hours after receiving their first full dose of EPKINLY on day 15 of cycle 1 due to the risk of CRS and neurologic problems. Tell your healthcare provider or get medical help right away if you develop a fever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble breathing; chills; fast heartbeat; feeling anxious; headache; confusion; shaking (tremors); problems with balance and movement, such as trouble walking; trouble speaking or writing; confusion and disorientation; drowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory loss. These may be symptoms of CRS or neurologic problems. If you have any symptoms that impair consciousness, do not drive or use heavy machinery or do other dangerous activities until your symptoms go away. EPKINLY can cause other serious side effects, including: Infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment and treat you as needed if you develop an infection. You should receive medicines from your healthcare provider before you start treatment to help prevent infection. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, or feeling weak or generally unwell. Low blood cell counts, which can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cells (neutropenia), which can increase your risk for infection; low red blood cells (anemia), which can cause tiredness and shortness of breath; and low platelets (thrombocytopenia), which can cause bruising or bleeding problems. Your healthcare provider will monitor you for symptoms of CRS, neurologic problems, infections, and low blood cell counts during treatment with EPKINLY. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects. Before you receive EPKINLY, tell your healthcare provider about all your medical conditions, including if you have an infection, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. If you receive EPKINLY while pregnant, it may harm your unborn baby. If you are a female who can become pregnant, your healthcare provider should do a pregnancy test before you start treatment with EPKINLY and you should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY. In DLBCL or high-grade B-cell lymphoma, the most common side effects of EPKINLY include CRS, tiredness, muscle and bone pain, injection site reactions, fever, stomach-area (abdominal) pain, nausea, and diarrhea. The most common severe abnormal laboratory test results include decreased white blood cells, decreased red blood cells, and decreased platelets. In follicular lymphoma the most common side effects of EPKINLY include injection site reactions, CRS, COVID-19, tiredness, upper respiratory tract infections, muscle and bone pain, rash, diarrhea, fever, cough, and headache. The most common severe abnormal laboratory test results include decreased white blood cells and decreased red blood cells. These are not all of the possible side effects of EPKINLY. Call your doctor for medical advice about side effects. You are encouraged to report side effects to the FDA at (800) FDA-1088 or or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622). Please see Full Prescribing Information and Medication Guide, including Important Warnings. Globally, prescribing information varies; refer to the individual country product label for complete information. About Genmab Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO®) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit and follow us on LinkedIn and X. This Company Announcement contains forward looking statements. The words "believe," "expect," "anticipate," "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab's most recent financial reports, which are available on and the risk factors included in Genmab's most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®, HexElect® and KYSO™. EPCORE®, EPKINLY®, TEPKINLY® and their designs are trademarks of AbbVie Biotechnology Ltd. _____________________________________________i Lymphoma Research Foundation official website. Accessed November Leukemia & Lymphoma Society. Accessed November Ghione P, Palomba ML, Ghesquieres H, et al. Treatment patterns and outcomes in relapsed/refractory follicular lymphoma: results from the international SCHOLAR-5 study. Haematologica. 2023;108(3):822-832. doi: 10.3324/ Rivas-Delgado A, Magnano L, Moreno-Velázquez M, et al. Response duration and survival shorten after each relapse in patients with follicular lymphoma treated in the rituximab era. Br J Haematol. 2018;184(5):753-759. doi:10.1111/bjh.15708.v Al-Tourah AJ, Gill KK, Chhanabhai M, et al. Population-based analysis of incidence and outcome of transformed non-Hodgkin's lymphoma. J Clin Oncol. 2008 Nov 10;26(32):5165-9. doi: 10.1200/JCO.2008.16.0283. Epub 2008 Oct 6. PMID: Engelberts PJ, et al. DuoBody-CD3xCD20 Induces Potent T-Cell-Mediated Killing of Malignant B Cells in Preclinical Models and Provides Opportunities for Subcutaneous Dosing. EBioMedicine. 2020;52:102625. doi: 10.1016/ View source version on Contacts Marisol Peron, Senior Vice President, Global Communications & Corporate AffairsT: +1 609 955 2392; E: mape@ Andrew Carlsen, Vice President, Head of Investor RelationsT: +45 3377 9558; E: acn@
Yahoo
07-08-2025
- Business
- Yahoo
Genmab Announces Financial Results for the First Half of 2025
August 7, 2025 Copenhagen, Denmark; Interim Report for the First Half Ended June 30, 2025 Highlights Epcoritamab advancing to earlier lines of therapy with the submission of a sBLA to the FDA for epcoritamab plus R2 in patients with relapsed or refractory FL Rinatabart sesutecan (Rina-S®) continues to progress, demonstrating encouraging antitumor activity in endometrial cancer in data presented at the 2025 ASCO Annual Meeting Data from over 40 abstracts highlighting the depth, breadth and strength of Genmab's comprehensive epcoritamab development program presented at multiple medical conferences Genmab revenue increased 19% compared to the first six months of 2024, to $1,640 million 'In the first half of the year we continued to make progress towards our strategic priorities as we strive towards our goal of bringing our innovative therapies to additional patients in need. We further maximized the potential of our commercialized medicines with an additional sBLA submission for EPKINLY® (epcoritamab-bysp) and the launch of Tivdak® (tisotumab vedotin) in Japan. We also accelerated the development of our late-stage pipeline through both encouraging data presentations and, for Rina-S, the announcement of additional planned Phase 3 clinical trials,' said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. Financial Performance First Half of 2025 Revenue was $1,640 million for the first six months of 2025 compared to $1,382 million for the first six months of 2024. The increase of $258 million, or 19%, was primarily driven by higher DARZALEX® and Kesimpta® royalties achieved under our collaborations with Johnson & Johnson (J&J) and Novartis Pharma AG (Novartis), respectively, and higher EPKINLY net product sales. Royalty revenue was $1,378 million in the first six months of 2025 compared to $1,111 million in the first six months of 2024, an increase of $267 million, or 24%. The increase in royalties was driven by higher net sales of DARZALEX and Kesimpta. Net sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO® in the U.S.) by J&J were $6,776 million in the first six months of 2025 compared to $5,570 million in the first six months of 2024, an increase of $1,206 million or 22%. Total costs and operating expenses were $1,092 million in the first six months of 2025 compared to $1,030 million in the first six months of 2024. The increase of $62 million, or 6%, was driven by the expansion of our product pipeline, including advancement of Rina-S, the continued development of Genmab's broader organizational capabilities as well as profit-sharing amounts payable to AbbVie Inc. (AbbVie) related to EPKINLY sales. Operating profit was $548 million in the first six months of 2025 compared to $352 million in the first six months of 2024. Net financial items resulted in income of $119 million for the first six months of 2025 compared to $204 million in the first six months of 2024. The decrease was primarily due to a decrease in foreign exchange impacts driven by the change in functional currency of Genmab A/S on January 1, 2025, as well as a decrease in interest income for the first six months of 2025 compared to the first six months of 2024 related to average lower cash balances. OutlookGenmab is updating its revenue and operating profit guidance for 2025. The improved guidance is driven by higher total royalty revenues from DARZALEX. 2025 FULL YEAR OUTLOOK (USD million) Revised Guidance Revised Mid-Point Previous Guidance Guidance Mid-Point Revenue 3,500 - 3,700 3,600 3,340 - 3,660 3,500 Royalties 2,945 - 3,090 3,017 2,785 - 3,015 2,900 Net product sales/Collaboration revenue* 425 - 465 445 415 - 460 438 Milestones/Reimbursement revenue 130 - 145 138 140 - 185 162 Gross profit** 3,280 - 3,460 3,370 3,120 - 3,420 3,270 Operating expenses** (2,055) - (2,225) (2,140) (2,055) - (2,225) (2,140) Operating profit 1,055 - 1,405 1,230 895 - 1,365 1,130 Net Product Sales and Collaboration Revenue consists of EPKINLY Net Product Sales in the U.S. and Japan and Tivdak (Genmab's share of net profits) in the U.S. and Net Product Sales in Japan Operating Expenses Range excludes Cost of Product Sales Range, which is included in Gross Profit Range Other MattersBoth the functional currency of the Genmab A/S legal entity and the presentation currency of the condensed consolidated financials statements have been changed from DKK to USD effective January 1, 2025. The change in functional currency has been implemented with prospective effect. The change in presentation currency has been implemented with retrospective effect. Comparative figures for prior periods have been restated accordingly. Conference CallGenmab will hold a conference call to discuss the results for the first half of 2025 today, Thursday, August 7, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call please use the below registration link. Registered participants will receive an email with a link to access dial-in information as well as a unique personal PIN: A live and archived webcast of the call and relevant slides will be available at ContactMarisol Peron, Senior Vice President, Global Communications & Corporate AffairsT: +1 609 524 0065; E: mmp@ Andrew Carlsen, Vice President, Head of Investor RelationsT: +45 3377 9558; E: acn@ *sBLA = supplemental Biologics License Application, FDA = U.S. Food and Drug Administration, R2 = rituximab and lenalidomide, FL = follicular lymphoma, ASCO = American Society of Clinical Oncology The Interim Report contains forward looking statements. The words 'believe,' 'expect,' 'anticipate,' 'intend' and 'plan' and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab's most recent financial reports, which are available on and the risk factors included in Genmab's most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at Genmab does not undertake any obligation to update or revise forward looking statements in the Interim Report nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®; HexElect® and KYSO®; ProfoundBio™ and Rina-S® are trademarks of ProfoundBio, US, Co. and ProfoundBio (Suzhou) Co., Ltd. Tivdak® is a trademark of Seagen Inc.; EPCORE®, EPKINLY®, TEPKINLY® and their designs are trademarks of AbbVie Biotechnology Ltd.; Kesimpta® and Sensoready® are trademarks of Novartis AG or its affiliates; DARZALEX®, DARZALEX FASPRO®, RYBREVANT®, TECVAYLI® and TALVEY® are trademarks of Johnson & Johnson; TEPEZZA® is a trademark of Horizon Therapeutics Ireland DAC. Download the full Interim Report for the First Half of 2025 on attachment or at CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122 Genmab A/SCarl Jacobsens Vej 302500 Valby Denmark Attachment 070825_CA40_Genmab Interim Report H1 2025
Yahoo
07-08-2025
- Business
- Yahoo
Genmab Announces Financial Results for the First Half of 2025
August 7, 2025 Copenhagen, Denmark; Interim Report for the First Half Ended June 30, 2025 Highlights Epcoritamab advancing to earlier lines of therapy with the submission of a sBLA to the FDA for epcoritamab plus R2 in patients with relapsed or refractory FL Rinatabart sesutecan (Rina-S®) continues to progress, demonstrating encouraging antitumor activity in endometrial cancer in data presented at the 2025 ASCO Annual Meeting Data from over 40 abstracts highlighting the depth, breadth and strength of Genmab's comprehensive epcoritamab development program presented at multiple medical conferences Genmab revenue increased 19% compared to the first six months of 2024, to $1,640 million 'In the first half of the year we continued to make progress towards our strategic priorities as we strive towards our goal of bringing our innovative therapies to additional patients in need. We further maximized the potential of our commercialized medicines with an additional sBLA submission for EPKINLY® (epcoritamab-bysp) and the launch of Tivdak® (tisotumab vedotin) in Japan. We also accelerated the development of our late-stage pipeline through both encouraging data presentations and, for Rina-S, the announcement of additional planned Phase 3 clinical trials,' said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. Financial Performance First Half of 2025 Revenue was $1,640 million for the first six months of 2025 compared to $1,382 million for the first six months of 2024. The increase of $258 million, or 19%, was primarily driven by higher DARZALEX® and Kesimpta® royalties achieved under our collaborations with Johnson & Johnson (J&J) and Novartis Pharma AG (Novartis), respectively, and higher EPKINLY net product sales. Royalty revenue was $1,378 million in the first six months of 2025 compared to $1,111 million in the first six months of 2024, an increase of $267 million, or 24%. The increase in royalties was driven by higher net sales of DARZALEX and Kesimpta. Net sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO® in the U.S.) by J&J were $6,776 million in the first six months of 2025 compared to $5,570 million in the first six months of 2024, an increase of $1,206 million or 22%. Total costs and operating expenses were $1,092 million in the first six months of 2025 compared to $1,030 million in the first six months of 2024. The increase of $62 million, or 6%, was driven by the expansion of our product pipeline, including advancement of Rina-S, the continued development of Genmab's broader organizational capabilities as well as profit-sharing amounts payable to AbbVie Inc. (AbbVie) related to EPKINLY sales. Operating profit was $548 million in the first six months of 2025 compared to $352 million in the first six months of 2024. Net financial items resulted in income of $119 million for the first six months of 2025 compared to $204 million in the first six months of 2024. The decrease was primarily due to a decrease in foreign exchange impacts driven by the change in functional currency of Genmab A/S on January 1, 2025, as well as a decrease in interest income for the first six months of 2025 compared to the first six months of 2024 related to average lower cash balances. OutlookGenmab is updating its revenue and operating profit guidance for 2025. The improved guidance is driven by higher total royalty revenues from DARZALEX. 2025 FULL YEAR OUTLOOK (USD million) Revised Guidance Revised Mid-Point Previous Guidance Guidance Mid-Point Revenue 3,500 - 3,700 3,600 3,340 - 3,660 3,500 Royalties 2,945 - 3,090 3,017 2,785 - 3,015 2,900 Net product sales/Collaboration revenue* 425 - 465 445 415 - 460 438 Milestones/Reimbursement revenue 130 - 145 138 140 - 185 162 Gross profit** 3,280 - 3,460 3,370 3,120 - 3,420 3,270 Operating expenses** (2,055) - (2,225) (2,140) (2,055) - (2,225) (2,140) Operating profit 1,055 - 1,405 1,230 895 - 1,365 1,130 Net Product Sales and Collaboration Revenue consists of EPKINLY Net Product Sales in the U.S. and Japan and Tivdak (Genmab's share of net profits) in the U.S. and Net Product Sales in Japan Operating Expenses Range excludes Cost of Product Sales Range, which is included in Gross Profit Range Other MattersBoth the functional currency of the Genmab A/S legal entity and the presentation currency of the condensed consolidated financials statements have been changed from DKK to USD effective January 1, 2025. The change in functional currency has been implemented with prospective effect. The change in presentation currency has been implemented with retrospective effect. Comparative figures for prior periods have been restated accordingly. Conference CallGenmab will hold a conference call to discuss the results for the first half of 2025 today, Thursday, August 7, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call please use the below registration link. Registered participants will receive an email with a link to access dial-in information as well as a unique personal PIN: A live and archived webcast of the call and relevant slides will be available at ContactMarisol Peron, Senior Vice President, Global Communications & Corporate AffairsT: +1 609 524 0065; E: mmp@ Andrew Carlsen, Vice President, Head of Investor RelationsT: +45 3377 9558; E: acn@ *sBLA = supplemental Biologics License Application, FDA = U.S. Food and Drug Administration, R2 = rituximab and lenalidomide, FL = follicular lymphoma, ASCO = American Society of Clinical Oncology The Interim Report contains forward looking statements. The words 'believe,' 'expect,' 'anticipate,' 'intend' and 'plan' and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab's most recent financial reports, which are available on and the risk factors included in Genmab's most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at Genmab does not undertake any obligation to update or revise forward looking statements in the Interim Report nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®; HexElect® and KYSO®; ProfoundBio™ and Rina-S® are trademarks of ProfoundBio, US, Co. and ProfoundBio (Suzhou) Co., Ltd. Tivdak® is a trademark of Seagen Inc.; EPCORE®, EPKINLY®, TEPKINLY® and their designs are trademarks of AbbVie Biotechnology Ltd.; Kesimpta® and Sensoready® are trademarks of Novartis AG or its affiliates; DARZALEX®, DARZALEX FASPRO®, RYBREVANT®, TECVAYLI® and TALVEY® are trademarks of Johnson & Johnson; TEPEZZA® is a trademark of Horizon Therapeutics Ireland DAC. Download the full Interim Report for the First Half of 2025 on attachment or at CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122 Genmab A/SCarl Jacobsens Vej 302500 Valby Denmark Attachment 070825_CA40_Genmab Interim Report H1 2025Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Globe and Mail
12-06-2025
- Business
- Globe and Mail
Diffuse Large B-Cell Clinical Trial Analysis: Key Insights into Rich Pipeline Featuring 70+ Companies and 75+ Therapies
DelveInsight's, ' Diffuse Large B-Cell Lymphoma Pipeline Insight 2025 ' report provides comprehensive insights about 70+ companies and 75+ pipeline drugs in Diffuse Large B-Cell Lymphoma pipeline landscape. It covers the Diffuse Large B-Cell Lymphoma pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Diffuse Large B-Cell Lymphoma therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive Diffuse Large B-Cell Lymphoma pipeline products in this space. Stay ahead with the latest insights! Download DelveInsight's comprehensive Diffuse Large B-Cell Lymphoma Pipeline Report to explore emerging therapies, key Diffuse Large B-Cell Lymphoma Companies, and future Diffuse Large B-Cell Lymphoma treatment landscapes @ Diffuse Large B-Cell Lymphoma Pipeline Outlook Report Key Takeaways from the Diffuse Large B-Cell Lymphoma Pipeline Report In June 2025, Genmab announced a study will assess how safe and effective epcoritamab plus lenalidomide (E-Len) is compared to rituximab plus gemcitabine and oxaliplatin (R-GemOx) )in treating adult participants with relapsed or refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL). Adverse events and change in disease condition will be assessed. In June 2025, Mitsubishi Tanabe Pharma Corporation conducted a phase I/II Open-Label Study of MT-2111 in Patients With Relapsed/Refractory DLBCL. DelveInsight's Diffuse Large B-Cell Lymphoma pipeline report depicts a robust space with 70+ active players working to develop 75+ pipeline therapies for Diffuse Large B-Cell Lymphoma treatment. The leading Diffuse Large B-Cell Lymphoma Companies such as Miltenyi Biomedicine, Adicet Bio, VelosBio, Novartis Pharmaceuticals, Sanofi, Eisai Co, Schrodinger, Sana Biotechnology, Ranok Therapeutics, Monte Rosa Therapeutic, Otsuka Pharmaceutical, OncoNano Medicine, Regeneron Pharmaceuticals, Hoffmann-La Roche, Celgene, Nurix Therapeutics, NovalGen, Nektar Therapeutics, Genentech, CSPC ZhongQi Pharmaceutical Technology and others. Promising Diffuse Large B-Cell Lymphoma Therapies such as Ibrutinib, Bendamustine, Rituximab, R-miniCHOP, Selinexor, Tafasitamab, Lenalidomide, and others. Discover how the Diffuse Large B-Cell Lymphoma treatment paradigm is evolving. Access DelveInsight's in-depth Diffuse Large B-Cell Lymphoma Pipeline Analysis for a closer look at promising breakthroughs @ Diffuse Large B-Cell Lymphoma Clinical Trials and Studies Diffuse Large B-Cell Lymphoma Emerging Drugs Profile Brentuximab vedotin: Pfizer Brentuximab vedotin (Adcetris) is an anti-neoplastic agent. It is indicated for the treatment of patients with Classical Hodgkin lymphoma (HL) after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates. Adcetris is also indicated for the treatment of adult patients with CD30+ Hodgkin lymphoma at increased risk of relapse or progression following autologous stem cell transplant (ASCT), also indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma, for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy, for the treatment of adult patients with relapsed or refractory CD30+ cutaneous T- cell lymphoma (CTCL) after at least 1 prior systemic therapy. Adcetris is indicated for the first-line pediatric treatment for CD30-positive Hodgkin lymphoma. Currently, the drug is in Phase III stage of its clinical trial for the treatment of Diffuse Large B Cell Lymphoma. THOR-707: Sanofi THOR-707 is a precisely PEGylated version of IL-2, where the PEG chain is attached to a novel amino acid inserted at a location on IL-2 that prevents it from engaging the alpha-receptor and binding to immune receptors that cause drug toxicities (IL-2R-alpha, CD25). The engineered IL-2 retains near-native binding to the beta-gamma receptors that selectively expand tumor-killing T effector cells and Natural Killer (NK) cells without the alpha-mediated immunosuppressive effects of regulatory T cells or eosinophil-mediated vascular leak syndrome. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Diffuse Large B Cell Lymphoma. Abexinostat: Xynomic Pharmaceuticals Abexinostat (Xynomic Pharmaceuticals) is a broad histone deacetylase (HDAC) inhibitor. HDAC enzymes (also known as lysine deacetylase) cleave acetyl groups from N-acetyl lysine amino acids on a histone. HDAC inhibition leads to highly acetylated histones and chromatin reshaping. In addition to altering histone acetylation, HDAC inhibitors can also influence the degree of acetylation on non-histone proteins, increasing or repressing their activity. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Diffuse Large B-cell lymphoma. RNK05047: Ranok Therapeutics RNK05047 is a first-in-class, small-molecule, tumor- and BRD4-selective protein degrader that was discovered and developed using Ranok's proprietary approach to targeted protein degradation, CHAMPTM. The bromodomain transcription factor BRD4 is a key regulator of oncogenes such as MYC and BCL2 and is involved in diverse cancer types. CHAMP-1 is a Phase I/II trial of RNK05047 currently underway in the US that will assess its safety, tolerability, and pharmacokinetics, and also includes measures of anti-tumor activity and pharmacodynamics readouts as secondary endpoints. BMF-219: Biomea Fusion BMF-219 is an oral investigational covalent menin inhibitor. Data suggests that optimized covalent inhibitors can provide deeper inhibition while being better tolerated than some conventional reversible inhibitors. BMF-219 is being developed for genetically defined AML, ALL, DLBCL, MM and CLL patients. BMF-219 blocks the interaction of menin and MLL (AML, ALL), and limits the activity and/or expression of NPM1, MYC, HOX, and MEIS1, all known drivers of oncogenic proliferation and survival. Currently, the drug is in Phase I stage of its clinical trial for the treatment of Diffuse Large B Cell Lymphoma. ADI-001: Adicet Bio ADI-001 is an investigational allogeneic gamma delta CAR T cell therapy being developed as a potential treatment for relapsed or refractory B-cell NHL. ADI-001 targets malignant B-cells via an anti-CD20 CAR and via the gamma delta innate and T cell endogenous cytotoxicity receptors. Gamma delta T cells engineered with an anti-CD20 CAR have demonstrated potent anti-tumor activity in preclinical models, leading to long-term control of tumor growth. In April 2022, ADI-001 was granted Fast Track Designation by the FDA for the potential treatment of relapsed or refractory B-cell NHL. Currently, the drug is in Phase I stage of its clinical trial for the treatment of Diffuse Large B Cell Lymphoma. The Diffuse Large B-Cell Lymphoma pipeline report provides insights into The report provides detailed insights about companies that are developing therapies for the treatment of Diffuse Large B-Cell Lymphoma with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Diffuse Large B-Cell Lymphoma Treatment. Diffuse Large B-Cell Lymphoma Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Diffuse Large B-Cell Lymphoma Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Diffuse Large B-Cell Lymphoma market. Get a detailed analysis of the latest innovations in the Diffuse Large B-Cell Lymphoma pipeline. Explore DelveInsight's expert-driven report today! @ Diffuse Large B-Cell Lymphoma Unmet Needs Diffuse Large B-Cell Lymphoma Companies Miltenyi Biomedicine, Adicet Bio, VelosBio, Novartis Pharmaceuticals, Sanofi, Eisai Co, Schrodinger, Sana Biotechnology, Ranok Therapeutics, Monte Rosa Therapeutic, Otsuka Pharmaceutical, OncoNano Medicine, Regeneron Pharmaceuticals, Hoffmann-La Roche, Celgene, Nurix Therapeutics, NovalGen, Nektar Therapeutics, Genentech, CSPC ZhongQi Pharmaceutical Technology and others. Diffuse Large B-Cell Lymphoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Diffuse Large B-Cell Lymphoma Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Download DelveInsight's latest report to gain strategic insights into upcoming Diffuse Large B-Cell Lymphoma Therapies and key Diffuse Large B-Cell Lymphoma Developments @ Diffuse Large B-Cell Lymphoma Market Drivers and Barriers, and Future Perspectives Scope of the Diffuse Large B-Cell Lymphoma Pipeline Report Coverage- Global Diffuse Large B-Cell Lymphoma Companies- Miltenyi Biomedicine, Adicet Bio, VelosBio, Novartis Pharmaceuticals, Sanofi, Eisai Co, Schrodinger, Sana Biotechnology, Ranok Therapeutics, Monte Rosa Therapeutic, Otsuka Pharmaceutical, OncoNano Medicine, Regeneron Pharmaceuticals, Hoffmann-La Roche, Celgene, Nurix Therapeutics, NovalGen, Nektar Therapeutics, Genentech, CSPC ZhongQi Pharmaceutical Technology and others. Diffuse Large B-Cell Lymphoma Therapies - Ibrutinib, Bendamustine, Rituximab, R-miniCHOP, Selinexor, Tafasitamab, Lenalidomide, and others. Diffuse Large B-Cell Lymphoma Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Diffuse Large B-Cell Lymphoma Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Which companies are leading the race in Diffuse Large B-Cell Lymphoma drug development? Find out in DelveInsight's exclusive Diffuse Large B-Cell Lymphoma Pipeline Report—access it now! @ Diffuse Large B-Cell Lymphoma Emerging Drugs and Major Companies Table of Content Introduction Executive Summary Diffuse Large B-Cell Lymphoma: Overview Pipeline Therapeutics Therapeutic Assessment Diffuse Large B-Cell Lymphoma– DelveInsight's Analytical Perspective Late Stage Products (Phase III) Brentuximab vedotin: Pfizer Drug profiles in the detailed report….. Mid Stage Products (Phase II) THOR-707: Sanofi Drug profiles in the detailed report….. Early Stage Products (Phase I) ADI-001: Adicet Bio Drug profiles in the detailed report….. Preclinical and Discovery Stage Products Drug name: Company name Drug profiles in the detailed report….. Inactive Products Diffuse Large B-Cell Lymphoma Key Companies Diffuse Large B-Cell Lymphoma Key Products Diffuse Large B-Cell Lymphoma- Unmet Needs Diffuse Large B-Cell Lymphoma- Market Drivers and Barriers Diffuse Large B-Cell Lymphoma- Future Perspectives and Conclusion Diffuse Large B-Cell Lymphoma Analyst Views Diffuse Large B-Cell Lymphoma Key Companies Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Yash Bhardwaj Email: Send Email Phone: 09650213330 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: NV Country: United States Website:
North Wales Chronicle
20-05-2025
- Entertainment
- North Wales Chronicle
Mike Peters' funeral to draw fans worldwide to Dyserth
Mike Peters's funeral will be held on Thursday, May 29 at 3pm at the Parish Church of St Bridget and St Cwyfan in Dyserth. North Wales Police and Denbighshire County Council have agreed to close down Waterfall Road for the funeral. Fans from across the world as well as loved ones, friends and those from the music world are expected to attend. Mike's wife Jules posted on social media: "We are so touched by the outpouring of love from our local community and beyond, towards our local boy Michael Leslie Peters. "Born in Dyserth and laid to rest in Dyserth. You couldn't write the script. "So please make your plans to join us on Thursday, May 29 at 3pm to celebrate the incredible life of Mikey Peters… "I'll be releasing all the logistics over the next few days. "I'm so overwhelmed by all the people who are making the trip from overseas… "I always knew how MP was so loved, such was his humility and kindness with everyone he met… but the outpouring has been unprecedented." People are encouraged to arrive before 2pm at the Dyserth church. Jules revealed that Mike "never once thought he was losing this fight". The talented musician, who lived in Dyserth, died aged 66 on April 29. The father to Dylan and Evan, who supported U2 and Status Quo on tour and played with Bob Dylan and Bruce Springsteen, was first diagnosed with the blood cancer chronic lymphocytic leukaemia (CLL) more than 30 years ago, aged 36. In October 2024, Mike developed Richter's syndrome where his CLL changed into an aggressive fast-growing lymphoma. He underwent experimental treatment at The Christie NHS Foundation Trust in Manchester. Talking about organising Mike's funeral, Jules said: "When I realised that i was responsible for organising the funeral I set about it as if I was producing 'The Gathering', a Mike Peters event that I have produced for over 30 years… "Based on our very 'loose' funeral discussions (as you must remember that MLP never once thought he was losing this fight) Mike was confident right to the very end that he was going to receive the full dose of Epcoritamab and then continue to a new life of maintenance. "This is why the end came as a shock… "I'm so happy that this confidence permeated all of the last year for Mike. determination and resilience and at another time I would like to discuss this further. "My job recently has been to facilitate confidence with Mike, despite my growing inner fears. That has taken all of me if I'm honest as my whole intention this past year has been to protect Mike and support him in his wishes… "Mike didn't think he was going to die and so he never wanted the difficult conversation… he certainly wasn't particularly interested in discussing funerals… boring! "I'll share more over the next few days, weeks and months but the one thing I wanted was a special place to lay Mike to rest and a special person to lay Mike to rest." Reverend Gregor Lachlann-Waddell will take Mike's service.
