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Genmab — Investor Relations & Filings

Ticker · GMAB ISIN · DK0010272202 LEI · 529900MTJPDPE4MHJ122 CO Manufacturing
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Filings indexed 2,823 across all filing types
Latest filing 2016-07-26 Regulatory Filings
Country DK Denmark
Listing CO GMAB

About Genmab

https://www.genmab.com/

Genmab is an international biotechnology company that specializes in the creation, development, and commercialization of differentiated antibody therapeutics. The company focuses on transforming the treatment of cancer and other serious diseases. By utilizing proprietary antibody technology platforms and scientific expertise, Genmab develops a pipeline of innovative medicines. Its activities span from discovery and research through clinical development to deliver novel therapies to patients.

Recent filings

Filing Released Lang Actions
Daratumumab tildeles Breakthrough Therapy-status af de amerikanske sundhedsmyndigheder (FDA) til tidligere behandlet myelomatose
Regulatory Filings Classification · 95% confidence The document is a corporate announcement (Selskabsmeddelelse nr. 31) from Genmab A/S regarding the FDA granting 'Breakthrough Therapy' status to their drug Daratumumab. It is a regulatory announcement concerning company operations and product development status, which falls under the 'Regulatory Filings' category as it does not fit into specific financial reporting or governance categories.
2016-07-26 English
Regulatory Filings 2016
Regulatory Filings Classification · 95% confidence The document is titled "Genmab Provides Update on Marketing Authorization Application for Arzerra® (ofatumumab) as Maintenance Therapy for Patients with Relapsed CLL" and is explicitly labeled as a "Company Announcement." It details the negative opinion issued by the CHMP (European Medicines Agency) regarding a Marketing Authorization Application (MAA) and provides clinical data updates. This type of announcement, which communicates a significant regulatory decision or clinical trial update outside of a standard periodic financial report (like 10-K or IR), fits best under the general category of regulatory or corporate news. Since it is not a full earnings release (ER), a formal financial report (IR/10-K), a management discussion (MDA), or a specific legal/insider filing, the most appropriate classification is the general Regulatory Filings category (RNS), as it is a broad announcement of a regulatory event.
2016-06-23 English
Regulatory Filings 2016
Regulatory Filings Classification · 100% confidence The document is titled "Company Announcement" and details a specific regulatory event: the Committee for Medicinal Products for Human Use (CHMP) issuing a negative opinion regarding the marketing authorization application (MAA) for the drug Arzerra. It includes clinical trial data summaries, management commentary, and standard corporate boilerplate, concluding with a company announcement number. This format is characteristic of a press release or official statement issued by a company to inform the market about a significant development, often related to product approval status or clinical trial results. Since it is not a full annual report (10-K), a quarterly report (IR), a transcript (CT), or a specific financial filing like a proxy statement (DEF 14A), it best fits the general category for official regulatory/corporate news that isn't covered by more specific codes. Given the context of a major regulatory decision announcement, it is most appropriately classified as a general Regulatory Filing (RNS), as it is a formal communication to the market about a regulatory outcome, or potentially an Earnings Release (ER) if this was part of a broader results announcement, but the focus here is purely regulatory/product news. RNS is the best fit as a broad regulatory announcement fallback.
2016-06-23 English
Genmab offentliggør en opdatering om markedsføringsansøgning for Arzerra® (ofatumumab) til vedligeholdelsesbehandling af patienter med recidiverende CLL
Regulatory Filings Classification · 95% confidence The document is a corporate announcement (Selskabsmeddelelse) from Genmab regarding a negative opinion from the CHMP (EMA) on a marketing application for their drug Arzerra. It details the clinical trial results (PROLONG study) and the regulatory outcome. This fits the definition of a regulatory announcement regarding company operations and product development, which falls under the RNS (Regulatory Filings) category as it is a specific corporate update that does not fit into financial reporting, M&A, or other specialized categories.
2016-06-23 English
Genmab offentliggør en opdatering om markedsføringsansøgning for Arzerra® (ofatumumab) til vedligeholdelsesbehandling af patienter med recidiverende CLL
Regulatory Filings Classification · 83% confidence The document is a corporate press release (“Selskabsmeddelelse”) announcing a negative CHMP opinion on Arzerra maintenance treatment, detailing clinical trial data and forward-looking statements. It does not contain financial statements, earnings highlights, management discussion of quarterly results, or notice of dividend. It is a regulatory announcement regarding product approval status rather than a formal financial report, so it falls under the general regulatory filings fallback category (RNS).
2016-06-23 Danish
Regulatory Filings 2016
Regulatory Filings
2016-06-09 Danish

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