Genmab - ADR

Genmab A/S operates as an international biotechnology company. The firm develops human antibody therapeutics for the treatment of cancer and other diseases. Its product pipeline include daratumumab, marketed as DARZALEX for the treatment of certain indications of multiple myeloma; teprotumumab-trbw marketed as TEPEZZA for the treatment of thyroid eye disease; and ofatumumab, marketed as Arzerra for the treatment of certain indications of chronic lymphocytic leukemia. The company was founded by Donald Lee Drakeman, Florian Schonharting, and Jan G. J. van de Winkel on June 11, 1998 and is headquartered in Copenhagen, Denmark.

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Genmab A/S is an international biotechnology company, which engages in the development of human antibody therapeutics for the treatment of cancer and other diseases. Its product pipeline includes daratumumab, marketed as DARZALEX for the treatment of certain indications of multiple myeloma; teprotumumab-trbw marketed as TEPEZZA for the treatment of thyroid eye disease; and ofatumumab, marketed as Arzerra for the treatment of certain indications of chronic lymphocytic leukemia. The company was founded by Donald Lee Drakeman, Florian Schonharting, and Jan G. J. van de Winkel on June 11, 1998, and is headquartered in Copenhagen, Denmark.

COPENHAGEN, Denmark--(BUSINESS WIRE)--Genmab A/S (Nasdaq: GMAB) and Pfizer, Inc. (NYSE PFE) today announced that the European Medicines Agency (EMA) has validated for review the marketing authorization application (MAA) of tisotumab vedotin, an antibody-drug conjugate (ADC), developed for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy. If approved, tisotumab vedotin would be the first ADC granted European Union.

Tisotumab Vedotin Marketing Authorization Application Validated by European Medicines Agency for Treatment of Recurrent or Metastatic Cervical Cancer

Genmab's appeal against Johnson & Johnson in an arbitration case has been denied, eliminating the potential upside for the company. Despite this setback, Genmab remains well positioned to create shareholder value through continued revenue growth and pipeline progression and expansion. The launch of Epkinly/Tepkinly and the growth of other products are expected to reduce Genmab's reliance on Darzalex royalties.

Genmab's Arbitration Loss: Best To Forgive And Forget (Rating Upgrade)

Company Announcement Net sales of DARZALEX® in 2023 totaled USD 9,744 million Genmab receives royalties on worldwide net sales from Janssen Biotech, Inc. (Janssen) COPENHAGEN, Denmark; January 23, 2024 – Genmab A/S (Nasdaq: GMAB) announced today that worldwide net trade 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.), as reported by Johnson & Johnson were USD 9,744 million in 2023. Net trade sales were USD 5,277 million in the U.S. and USD 4,467 million in the rest of the world.

Genmab Announces Net Sales of DARZALEX® (daratumumab) for 2023

Company Announcement COPENHAGEN, Denmark; January 23, 2024 – Genmab A/S (Nasdaq: GMAB) announced today that the appeal arbitrator in its second arbitration arising under its license agreement with Janssen Biotech, Inc. (Janssen) for daratumumab has denied Genmab's appeal. As a result, the dismissal of Genmab's claims in the second arbitration is now concluded.

Genmab Announces Decision in Arbitration Appeal under License Agreement with Janssen

After losing some value lately, a hammer chart pattern has been formed for Genmab A/S Sponsored ADR (GMAB), indicating that the stock has found support. This, combined with an upward trend in earnings estimate revisions, could lead to a trend reversal for the stock in the near term.

Genmab A/S Sponsored ADR (GMAB) May Find a Bottom Soon, Here's Why You Should Buy the Stock Now

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Genmab is a leading contender in the biotech industry with innovative technology, a robust pipeline, and strategic collaborations. Epcoritamab's growth is a positive trend to monitor, as it has shown impressive financial performance and secured regulatory approvals in multiple regions. DARZALEX, Genmab's flagship product, continues to be a substantial revenue driver, and investors should monitor its clinical programs for potential growth.

Genmab: 3 Trends To Track For A Strong 2024 And Beyond

Pfizer

NEW YORK & COPENHAGEN, Denmark--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) seeking to convert the accelerated approval of TIVDAK® (tisotumab vedotin-tftv) to full approval, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy. The application has been granted P.

TIVDAK® Supplemental Biologics License Application Accepted for Priority Review by FDA for Patients with Recurrent or Metastatic Cervical Cancer

COPENHAGEN, Denmark--(BUSINESS WIRE)--Genmab A/S (Nasdaq: GMAB) and Pfizer, Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) seeking to convert the accelerated approval of TIVDAK® (tisotumab vedotin-tftv) to full approval, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy. The application has been granted Priority Re.

TIVDAK® (tisotumab vedotin-tftv) Supplemental Biologics License Application Accepted for Priority Review by U.S. Food and Drug Administration for Patients with Recurrent or Metastatic Cervical Cancer

Media Release COPENHAGEN, Denmark; January 2, 2024 Genmab A/S (Nasdaq: GMAB) announced today that its CEO, Jan van de Winkel, Ph.D., will present a company update at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco at 11:15 AM PST / 2:15 PM EST / 8:15 PM CET on January 10, 2024. The live and archived webcast of the presentation will be available on Genmab's website at  https://ir.genmab.com/events-and-presentations#content .

Genmab to Present at the 42nd Annual J.P. Morgan Healthcare Conference

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Media Release Event to be held virtually via live webcast and archived on www.genmab.com Copenhagen, Denmark; December 12, 2023 – Genmab A/S (Nasdaq: GMAB) will hold its 2023 R&D Update and ASH Data Review Meeting today, December 12, 2023 at 11:00 AM Eastern Time (5:00 PM CET / 4:00 PM GMT).  The event will take place virtually in English and can be attended via live webcast.

Genmab to Hold 2023 R&D Update and ASH Data Review Meeting

AbbVie

-  Data from Phase 1/2 EPCORE™ NHL-1 study show patients treated with epcoritamab experienced 82% overall response rates (ORR) including 63% complete response (CR) rates as presented at the 65th American Society of Hematology (ASH) congress -  Follicular lymphoma is the second most common form of non-Hodgkin's lymphoma NORTH CHICAGO, Ill. , Dec. 9, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Genmab A/S (Nasdaq: GMAB) announced today that adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) previously treated with two or more prior therapies experienced strong and durable responses with high overall response (ORR) and complete response (CR) rates when treated with epcoritamab (DuoBody® CD3xCD20), an investigational, subcutaneously administered T-cell engaging bispecific antibody.

New Data for Bispecific Antibody Epcoritamab (DuoBody® CD3xCD20) Shows Strong, Durable Treatment Response for Patients with Difficult-To-Treat Relapsed/Refractory (R/R) Follicular Lymphoma (FL)

COPENHAGEN, Denmark--(BUSINESS WIRE)--Genmab A/S (Nasdaq: GMAB) and AbbVie (NYSE: ABBV) today announced new data from the ongoing phase 1/2 EPCORE™ NHL-1 clinical trial investigating epcoritamab (DuoBody® CD3xCD20), a T-cell engaging bispecific antibody administered subcutaneously, demonstrated an overall response rate (ORR) of 82 percent, a complete response (CR) rate of 63 percent and minimal residual disease (MRD) negativity rate of 67 percent in patients with relapsed/refractory (R/R) folli.

New Pivotal Data for Bispecific Antibody Epcoritamab (DuoBody® CD3xCD20) Demonstrates High Overall and Complete Responses in Patients with Hard-To-Treat Relapsed/Refractory Follicular Lymphoma (FL)

Harmony Biosciences Holdings

Investors interested in stocks from the Medical - Biomedical and Genetics sector have probably already heard of Harmony Biosciences Holdings, Inc. (HRMY) and Genmab A/S Sponsored ADR (GMAB). But which of these two stocks presents investors with the better value opportunity right now?

HRMY or GMAB: Which Is the Better Value Stock Right Now?

Media Release COPENHAGEN, Denmark; November 27, 2023 U.S. Food and Drug Administration (FDA) grants Breakthrough Therapy Designation (BTD) for epcoritamab-bysp for the treatment of relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy European Medicines Agency (EMA) validates regulatory application for epcoritamab for the same indication The regulatory actions are supported by data from the phase 1/2 EPCORE™ NHL-1 trial Genmab A/S (Nasdaq: GMAB ) today announced regulatory updates from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for epcoritamab, an investigational T-cell engaging bispecific antibody administered subcutaneously. The U.S. FDA has granted Breakthrough Therapy Designation (BTD) to epcoritamab-bysp for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.

Genmab Announces Positive Regulatory Updates for Epcoritamab (EPKINLY®/TEPKINLY®) for the Treatment of Relapsed/Refractory Follicular Lymphoma

Company Announcement COPENHAGEN, Denmark; November 21, 2023 – Genmab A/S (Nasdaq: GMAB) announced today that the Board decided to grant 10,541 restricted stock units to members of the Board of Directors and employees of the Company as well as the Company's subsidiaries and 7,651 warrants to employees of the Company and the Company's subsidiaries.  Each restricted stock unit is awarded cost-free and provides the owner with a right and obligation to receive one share in Genmab A/S of nominally DKK 1.

Grant of Restricted Stock Units to Board Members and Employees and Grant of Warrants to Employees in Genmab

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November 7, 2023 Copenhagen, Denmark; Interim Report for the First Nine Months Ended September 30, 2023 Highlights Epcoritamab (TEPKINLY ® ) was granted conditional marketing authorization by the European Commission (EC) to treat adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy Epcoritamab (EPKINLY ™ ) was approved by the Japan Ministry of Health, Labour and Welfare to treat adults with certain types of relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy Genmab and Seagen Inc. (Seagen) announced that the Phase 3 innovaTV 301 confirmatory trial of tisotumab vedotin for the treatment of recurrent or metastatic cervical cancer met its primary endpoint of improved overall survival (OS) at a predetermined, independent interim analysis Genmab revenue increased 26% compared to the first nine months of 2022, to DKK 11,796 million Genmab 2023 financial guidance updated “With regulatory approvals in Japan and Europe, EPKINLY/TEPKINLY is the first Genmab-owned medicine to become available to patients outside of the United States. In addition to being an important milestone for Genmab, these approvals mark an important milestone for patients in these territories who are in need of alternative therapeutic options,” said Jan van de Winkel, Ph.D.

Genmab Announces Financial Results for the First Nine Months of 2023

COPENHAGEN, Denmark--(BUSINESS WIRE)--Genmab A/S (Nasdaq: GMAB) announced today that multiple abstracts evaluating epcoritamab (DuoBody®-CD3xCD20), a T-cell engaging bispecific antibody administered subcutaneously, across a variety of treatment settings and hematologic malignancies have been accepted for presentation and publication at the 65th Annual Meeting and Exposition of the American Society of Hematology (ASH), being held in San Diego, California, and virtually, December 9-12. The presen.

Genmab Announces Multiple Abstracts to be Presented at the 65th Annual Meeting and Exposition of the American Society of Hematology (ASH)

BOTHELL, Wash., & COPENHAGEN, Denmark--(BUSINESS WIRE)--Seagen Inc. (Nasdaq: SGEN) and Genmab A/S (Nasdaq: GMAB) announced results today from the Phase 3 innovaTV 301 randomized global trial, which showed treatment with TIVDAK demonstrated a statistically significant and clinically meaningful 30% reduction in the risk of death in recurrent or metastatic cervical cancer patients with disease progression on or after first-line therapy, compared with chemotherapy (HR: 0.70, 95% CI: 0.54-0.89, p=0.

TIVDAK® (tisotumab vedotin-tftv) Significantly Prolonged Overall Survival in Patients with Recurrent or Metastatic Cervical Cancer Compared with Chemotherapy in Global Phase 3 innovaTV 301 Trial

Company Announcement Net sales of DARZALEX ® in the third quarter of 2023 totaled USD 2,499 million Genmab receives royalties on worldwide net sales from Janssen Biotech, Inc. (Janssen) COPENHAGEN, Denmark; October 17, 2023 – Genmab A/S (Nasdaq: GMAB) announced today that worldwide net trade 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. ) , as reported by Johnson & Johnson were USD 2,499 million in the third quarter of 2023. Net trade sales were USD 1,369 million in the U.S. and USD 1,130 million in the rest of the world.

Genmab Announces Net Sales of DARZALEX® (daratumumab) for Third Quarter of 2023

Company Announcement TEPKINLY ® (epcoritamab) is the first and only subcutaneous bispecific antibody approved as a monotherapy for adult patients with  relapsed or refractory ( R/R ) d iffuse large B-cell lymphoma ( DLBCL ) after two or more lines of systemic therapy Conditional marketing authorization approval from the European Commission is supported by data from the pivotal phase 1/2 EPCORE™ NHL-1 clinical trial , which demonstrated  62 percent overall response rate,  39  percent complete response, and 15. 5 -month median duration of response in challenging-to-treat   R/R DLBCL patients Epcoritamab represents the eight h approved medicine incorporating Genmab innovation and  fourth  created via Genmab's DuoBody ® technology platform COPENHAGEN, Denmark; September 25 , 2023 – Genmab A/S (Nasdaq: GMAB ) announced today that the European Commission (EC) has granted conditional marketing authorization for TEPKINLY® (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Genmab Announces European Commission Approval of TEPKINLY® (epcoritamab) for Adults with Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)

COPENHAGEN, Denmark--(BUSINESS WIRE)--Genmab A/S (Nasdaq: GMAB) announced today that the Japan Ministry of Health, Labour and Welfare has approved EPKINLY™ (epcoritamab) as the first and only T-cell engaging bispecific antibody treatment in Japan of adult patients with certain types of relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma.

EPKINLY™ (epcoritamab) Approved by Japan Ministry of Health, Labour and Welfare as the First Bispecific Antibody to Treat Adults Patients with Certain Types of Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL)

News for Genmab - ADR Stock (GMAB)