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Genmab - GMAB STOCK NEWS

Welcome to our dedicated news page for Genmab (Ticker: GMAB), a resource for investors and traders seeking the latest updates and insights on Genmab.

Our selection of high-quality news articles is accompanied by an expert summary from Rhea-AI, detailing the impact and sentiment surrounding the news at the time of release, providing a deeper understanding of how each news could potentially affect Genmab's stock performance. The page also features a concise end-of-day stock performance summary, highlighting the actual market reaction to each news event. The list of tags makes it easy to classify and navigate through different types of news, whether you're interested in earnings reports, stock offerings, stock splits, clinical trials, fda approvals, dividends or buybacks.

Designed with both novice traders and seasoned investors in mind, our page aims to simplify the complex world of stock market news. By combining real-time updates, Rhea-AI's analytical insights, and historical stock performance data, we provide a holistic view of Genmab's position in the market.

News
Genmab to Broaden and Strengthen Oncology Portfolio with Acquisition of ProfoundBio
Rhea-AI Summary
Genmab to acquire ProfoundBio for USD 1.8 billion in cash, gaining rights to three clinical candidates and ADC technology platforms. The acquisition will expand Genmab's pipeline and enhance its cancer treatment capabilities, with Rina-S as a potential best-in-class ADC targeting ovarian cancer and solid tumors.
Rhea-AI Impact
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End-of-Day
-2.2%
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acquisition
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U.S. FDA Accepts for Priority Review the Supplemental Biologics License Application for Epcoritamab (EPKINLY®) for Difficult-to-Treat Relapsed or Refractory Follicular Lymphoma
Rhea-AI Summary
Genmab A/S (GMAB) and AbbVie (ABBV) receive FDA Priority Review for epcoritamab in R/R follicular lymphoma, with a target action date of June 28, 2024. The sBLA submission is based on positive Phase 1/2 EPCORE™ NHL-1 trial results, showing promising treatment responses. Epcoritamab aims to address the unmet needs of difficult-to-treat FL patients, with potential utility across B-cell malignancies.
Rhea-AI Impact
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End-of-Day
0.1%
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clinical trial
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Tisotumab Vedotin Marketing Authorization Application Validated by European Medicines Agency for Treatment of Recurrent or Metastatic Cervical Cancer
Rhea-AI Summary
Genmab A/S and Pfizer, Inc. announced that the European Medicines Agency has validated the marketing authorization application of tisotumab vedotin for the treatment of recurrent or metastatic cervical cancer. The application is based on data from the Phase 3 innovaTV 301 trial, demonstrating superior overall survival, progression-free survival, and objective response rate compared to chemotherapy. The safety profile was consistent with previous data. If approved, tisotumab vedotin would be the first ADC granted EU marketing authorization for cervical cancer.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-1.31%
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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
Rhea-AI Summary
Genmab A/S (GMAB) and Pfizer, Inc. (PFE) announced that the FDA has accepted the sBLA for TIVDAK, with a PDUFA action date of May 9, 2024. This is based on positive results from the global phase 3 innovaTV 301 trial, demonstrating an overall survival benefit of tisotumab vedotin-tftv over chemotherapy for the treatment of patients with recurrent or metastatic cervical cancer.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-1.16%
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News
TIVDAK® Supplemental Biologics License Application Accepted for Priority Review by FDA for Patients with Recurrent or Metastatic Cervical Cancer
Rhea-AI Summary
Pfizer Inc. (PFE) and Genmab A/S (GMAB) announced the FDA's acceptance of the supplemental Biologics License Application (sBLA) seeking to convert the accelerated approval of TIVDAK to full approval for the treatment of patients with recurrent or metastatic cervical cancer with disease progression. The Phase 3 innovaTV 301 trial demonstrated a favorable benefit/risk profile, including improvement in overall survival, progression-free survival, and confirmed objective response rate in patients with previously treated recurrent or metastatic cervical cancer compared to chemotherapy.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-1.16%
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News
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)
Rhea-AI Summary
Genmab A/S (GMAB) and AbbVie (ABBV) reported new data from the phase 1/2 EPCORE™ NHL-1 clinical trial for epcoritamab, showing an 82% overall response rate, 63% complete response rate, and 67% minimal residual disease negativity in patients with relapsed/refractory follicular lymphoma. The study presented at the 65th ASH Annual Meeting and Exposition also highlighted an optimized dosing schedule for FL patients, reducing the risk and severity of cytokine release syndrome.
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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)
Rhea-AI Summary
AbbVie (NYSE: ABBV) and Genmab A/S (Nasdaq: GMAB) announced that adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) treated with epcoritamab experienced 82% overall response rates (ORR) including 63% complete response (CR) rates. The median duration of response was not reached. The FDA granted Breakthrough Therapy Designation to epcoritamab for the treatment of adult patients with R/R FL after two or more therapies.
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Genmab Announces Positive Regulatory Updates for Epcoritamab (EPKINLY®/TEPKINLY®) for the Treatment of Relapsed/Refractory Follicular Lymphoma
Rhea-AI Summary
Genmab A/S (GMAB) receives Breakthrough Therapy Designation from the FDA and regulatory application validation from the EMA for epcoritamab-bysp to treat relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. The FDA designation may expedite the development and review of the drug for serious or life-threatening diseases. The EMA's validation confirms that the application is complete and begins the scientific review process. The regulatory actions were supported by data from the EPCORE NHL-1 trial.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-2.91%
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Genmab Announces Multiple Abstracts to be Presented at the 65th Annual Meeting and Exposition of the American Society of Hematology (ASH)
Rhea-AI Summary
Genmab A/S announced that multiple abstracts evaluating epcoritamab and GEN3014 have been accepted for presentation at the 65th Annual Meeting and Exposition of the American Society of Hematology. The abstracts highlight data from clinical trials evaluating the safety and efficacy of epcoritamab in various lymphoma subtypes and GEN3014 in patients with multiple myeloma. Genmab will also host a virtual R&D Update and ASH Data Review on December 12.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-3.49%
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none
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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
Rhea-AI Summary
Seagen Inc. and Genmab A/S announced positive results from the Phase 3 innovaTV 301 trial, showing that TIVDAK demonstrated a 30% reduction in the risk of death in recurrent or metastatic cervical cancer patients compared to chemotherapy. TIVDAK also showed significant improvements in overall survival, progression-free survival, and objective response rate.
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Genmab

Nasdaq:GMAB

GMAB Rankings

#543 Ranked by Market Cap
#3670 Ranked by Stock Gains
N/A Ranked by Dividends

GMAB Stock Data

19.33B
64.64M
0.01%
7.22%
0.37%
Pharmaceutical Preparation Manufacturing
Manufacturing
Link
Denmark
Kalvebod Brygge 43

About GMAB

Genmab A/S is a Danish biotechnology company, founded in February 1999 by Florian Schönharting, at the time managing director of BankInvest Biomedical venture fund.