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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.

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.
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-2.2%
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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.
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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.
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-1.31%
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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.
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-1.16%
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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
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-1.16%
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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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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 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.
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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.
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-3.49%
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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

GMAB Stock Data

19.62B
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.