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Swedish Orphan Biovitrum — Investor Relations & Filings

Ticker · SOBI ISIN · SE0000872095 LEI · 549300124Y3MQI87PT35 ST Manufacturing
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Filings indexed 892 across all filing types
Latest filing 2022-02-25 Regulatory Filings
Country SE Sweden
Listing ST SOBI

About Swedish Orphan Biovitrum

https://www.sobi.com/en

Swedish Orphan Biovitrum (Sobi) is a specialized biopharmaceutical company dedicated to developing and delivering innovative treatments for rare and debilitating diseases. The company's primary focus is on the therapeutic areas of haematology and immunology, with a significant legacy and continued leadership in haemophilia care. Sobi addresses the high unmet medical needs of patients by advancing a pipeline of innovative medicines and working to expand patient access globally. The company's mission is to transform the lives of people affected by rare conditions through dedicated research, development, and global collaboration.

Recent filings

Filing Released Lang Actions
Gamifant (emapalumab) rekommenderas godkännande i Kina för behandling av primär hemofagocyterande lymfohistiocytos (HLH)
Regulatory Filings Classification · 95% confidence The document is titled "PRESSMEDDELANDE" (Press Release) and announces a regulatory recommendation from the Center for Drug Evaluation (CDE) in China regarding the drug Gamifant for a rare disease (HLH). It includes details about the drug, the disease, and concludes with standard corporate information and contact details, explicitly stating the information is being made public under EU market abuse regulations. This format is characteristic of an initial announcement of a significant corporate or regulatory event, rather than a comprehensive periodic report (like 10-K or IR) or a transcript. Since it is a specific regulatory/corporate announcement that doesn't fit perfectly into categories like DIV, DIRS, or MANG, and it is not a formal financial report, it falls best under the general category for regulatory announcements, which is RNS (Regulatory Filings), as per the fallback rule, although it strongly resembles an Earnings Release (ER) in structure, but the content is purely regulatory/drug approval news, not financial results highlights. Given the options, RNS is the most appropriate catch-all for this type of specific, non-financial-period-focused regulatory news release.
2022-02-25 Swedish
Gamifant (emapalumab) recommended for approval in China for treatment of primary haemophagocytic lymphohistiocytosis (HLH)
Regulatory Filings Classification · 95% confidence The document is a press release announcing a regulatory recommendation (CDE recommendation to NMPA) regarding a drug (Gamifant) approval in China. It contains company updates, product information, and concludes with a statement that the information is 'obliged to make public pursuant to the EU Market Abuse Regulation' and specifies the publication time and contact persons. This structure is typical of a general regulatory announcement or press release that doesn't fit the specific financial report categories (like 10-K, IR, ER). Since it is a general announcement of a regulatory/business event and not a specific financial report, the most appropriate fallback category is Regulatory Filings (RNS). The document length is relatively short (4395 chars), but it is the primary announcement itself, not an announcement *about* a report, so RPA is less suitable than RNS for this type of news release.
2022-02-25 English
Earnings Release 2021
Earnings Release Classification · 98% confidence The document text provides key financial highlights for two periods: 'Oktober – december 2021' (Q4) and 'Januari – december 2021' (Full Year), along with 'Utsikter 2022' (Outlook 2022). It details revenue, EBITA, EPS, and cash flow figures, comparing current periods to prior years. This structure—presenting summarized quarterly and annual financial performance data immediately following the period end—is characteristic of an Earnings Release (ER). It is not a full Annual Report (10-K) or a comprehensive Interim Report (IR) as it focuses on highlights and is likely the initial announcement before the full statutory filing. Since it contains the core results announcement, ER is the most appropriate classification. Q4 2021
2022-02-10 Swedish
Earnings Release 2021
Earnings Release Classification · 99% confidence The document text provides detailed financial results for two periods: 'October – December 2021' (Q4) and 'January – December 2021' (Full Year), along with a '2022 outlook'. It includes key metrics like Total revenue, EBITA, EPS, and segment performance (Haematology, Immunology). This structure is characteristic of a periodic financial report summarizing performance for a specific quarter and year-to-date. Since it covers a period shorter than a full year (Q4 is presented, and the full year is summarized), and it is comprehensive rather than just a brief highlight announcement, it aligns best with the definition of an Interim / Quarterly Report (IR). It is not a 10-K (Annual Report) because it focuses on quarterly/interim periods, nor is it a brief Earnings Release (ER) given the depth of the data presented. Q4 2021
2022-02-10 English
Kineret® (anakinra) erhåller positivt utlåtande från CHMP för behandling av patienter med covid-19-orsakad lunginflammation
Regulatory Filings Classification · 100% confidence The document is a press release dated December 16, 2021, from Swedish Orphan Biovitrum AB (Sobi) announcing that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Kineret (anakinra) for treating COVID-19-induced pneumonia in adults requiring oxygen. This is an announcement regarding a regulatory decision (positive opinion from CHMP leading to EMA recommendation) concerning a drug's indication. It is not a full Annual Report (10-K), an Interim Report (IR), or a Call Transcript (CT). It is a specific regulatory/clinical update. Since it announces a regulatory development (CHMP opinion) rather than being a general regulatory filing fallback (RNS) or a specific financial report, it best fits the category of a general announcement related to the company's operations and regulatory progress. Given the options, this type of announcement, which details clinical trial results (SAVE-MORE) leading to a regulatory recommendation, is often classified as a Regulatory Filing (RNS) if it doesn't fit a more specific category like Earnings Release (ER) or Capital Update (CAP). However, since it is a specific announcement about a regulatory milestone (CHMP opinion), and not a general regulatory filing, it is closest to a general announcement. In the context of these specific codes, RNS serves as the best general regulatory announcement fallback. It is not a Director's Dealing (DIRS), Dividend Notice (DIV), or Management Discussion (MDA). It is a formal announcement of a significant regulatory event.
2021-12-16 Swedish
Kineret® (anakinra) receives positive opinion from the CHMP for treatment of patients with COVID-19 pneumonia
Regulatory Filings Classification · 100% confidence The document is a press release from Swedish Orphan Biovitrum AB (Sobi) announcing that the CHMP of the EMA adopted a positive opinion for Kineret® for treating COVID-19 pneumonia. It details clinical trial results (SAVE-MORE phase 3) and provides background information on the drug and the involved research institute. The concluding paragraph states: "This information is information that Swedish Orphan Biovitrum AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out below, at 15:00 CET on 16 December 2021." This structure strongly indicates a formal regulatory announcement intended for immediate public disclosure, rather than a comprehensive financial report (like 10-K or IR) or a specific financial event filing. Since it is a general regulatory announcement concerning a significant event (positive opinion for a new indication) and fits the description of a general regulatory filing that doesn't fit other specific categories (like ER, DIV, CAP), the most appropriate classification is Regulatory Filings (RNS). It is not an Earnings Release (ER) as it focuses on regulatory/clinical news, nor is it a Call Transcript (CT) or Investor Presentation (IP).
2021-12-16 English

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