Welcome to our dedicated page for Genmab A/S news (Ticker: GMAB), a resource for investors and traders seeking the latest updates and insights on Genmab A/S stock.
Genmab A/S (NASDAQ: GMAB) is a pioneering biotechnology company founded in February 1999 and headquartered in Copenhagen, Denmark. Established by Florian Schönharting, the company focuses on the development and commercialization of innovative antibody therapeutics for the treatment of cancer and other serious diseases.
Genmab's proprietary antibody technologies include DuoBody, HexaBody, DuoHexaBody, and HexElect. These cutting-edge platforms have enabled the creation of multiple high-impact drugs in partnership with leading pharmaceutical companies:
- Darzalex: Developed with Johnson & Johnson, this drug is a standard treatment for multiple myeloma.
- Tepezza: Partnered with Horizon, this medication targets thyroid eye disease.
- Kesimpta: Developed with Novartis, it treats relapsing multiple sclerosis.
- Rybrevant: Another collaboration with Johnson & Johnson, this drug addresses non-small cell lung cancer (NSCLC).
- Tivdak: In partnership with Seagen, Tivdak is used for the treatment of cervical cancer.
- Epkinly: Partnered with AbbVie, Epkinly targets diffuse large B-cell lymphoma.
In addition to these marketed products, Genmab has a robust pipeline of candidates targeting various oncologic indications. The company's focus on antibody therapeutics places it at the forefront of biotechnological innovation, continually seeking better outcomes for patients worldwide.
Genmab's financial health is bolstered by its successful alliances and product sales, positioning it strongly for future growth and development. Investors and stakeholders can stay informed about the latest updates and relevant information regarding Genmab's performance, events, and developments through regular news releases.
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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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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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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.
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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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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 and Seagen announce additional results from the Phase 3 innovaTV 301 trial, showing that TIVDAK demonstrated a statistically significant reduction in the risk of death in cervical cancer patients compared to chemotherapy. The results were presented at the ESMO Congress 2023.
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FAQ
What does Genmab A/S specialize in?
Genmab A/S specializes in developing antibody therapeutics for the treatment of cancer and other serious diseases.
What are Genmab's proprietary antibody technologies?
Genmab's proprietary technologies include DuoBody, HexaBody, DuoHexaBody, and HexElect.
Which companies has Genmab partnered with?
Genmab has partnered with companies like Johnson & Johnson, Horizon, Novartis, Seagen, and AbbVie.
What is Darzalex?
Darzalex, developed in partnership with Johnson & Johnson, is a standard treatment for multiple myeloma.
What other products are in Genmab's portfolio?
Other products include Tepezza, Kesimpta, Rybrevant, Tivdak, and Epkinly.
What is Tepezza used for?
Tepezza, in partnership with Horizon, is used to treat thyroid eye disease.
Where is Genmab headquartered?
Genmab is headquartered in Copenhagen, Denmark.
How does Genmab's financial condition look?
Genmab's financial condition is strong, bolstered by successful alliances and product sales.
When was Genmab founded?
Genmab was founded in February 1999.
What is the focus of Genmab's pipeline candidates?
Genmab's pipeline candidates focus on various oncologic indications.
Genmab A/S
Nasdaq:GMAB
GMAB Rankings
GMAB Stock Data
18.00B
66.14M
0.01%
7.53%
0.39%
Pharmaceutical Preparation Manufacturing
Manufacturing
United States of America
Kalvebod Brygge 43