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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 2014-06-25 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
Sobi ansöker om EU-godkännande för Xiapex vid Peyronies sjukdom
Regulatory Filings Classification · 95% confidence The document is a press release dated June 25, 2014, announcing that Sobi has applied to the EMA for an expanded indication for Xiapex to cover Peyronie's disease. This is a specific corporate announcement regarding regulatory action (an application submission) and product development, not a full financial report (like 10-K or IR), a transcript (CT), or a general regulatory filing (RNS). It is a specific type of corporate news release. Since there is no specific category for 'Regulatory Application Announcement' or 'Product Update Announcement', and it is not a formal financial filing, it falls best under the general 'Regulatory Filings' (RNS) as a catch-all for significant, non-financial, non-management-change corporate news, or potentially 'LTR' if viewed as a regulatory matter, but RNS is the standard fallback for press releases that don't fit elsewhere. Given the context of a press release announcing a regulatory step, RNS is the most appropriate general classification.
2014-06-25 Swedish
Sobi to review preclinical data to potentially add future haemophilia A candidate to collaboration agreement with Biogen Idec
M&A Activity Classification · 99% confidence The document is a press release dated June 16, 2014, announcing Sobi's review of preclinical data from Biogen Idec regarding a Haemophilia A program and the potential exercise of an option under their collaboration agreement. It discusses ongoing collaboration terms, disease background, and company information. This type of announcement, detailing strategic business developments, partnership updates, or clinical/preclinical milestones outside of standard mandatory financial reports (like 10-K or ER), typically falls under general corporate news or regulatory filings. Since it is a specific announcement about a potential transaction/option exercise related to a collaboration, it is best classified as a general Regulatory Filing (RNS) as it doesn't fit the specific categories like M&A (TAR), Financing (CAP), or Earnings Release (ER). Given the content is a specific corporate update released to the public, RNS is the most appropriate fallback.
2014-06-16 English
Sobi granskar preklinisk data gällande en framtida läkemedelskandidat för hemofili A för att eventuellt utöka samarbetsavtalet med Biogen Idec
Regulatory Filings Classification · 95% confidence The document is titled "PRESSMEDDELANDE" (Press Release) and announces that Sobi is reviewing preclinical data for a hemophilia A drug candidate to potentially expand a collaboration agreement with Biogen Idec. It details the timeline for exercising an option based on this review. This type of announcement, which communicates a specific business development, partnership update, or material event to the public and investors, fits best under the general category of regulatory announcements or news releases that are not formal financial reports (like 10-K or IR) or specific transaction reports (like DIRS or DIV). Since it is a specific business update that doesn't fit the other specialized categories (like M&A, Capital Change, or Earnings Release), the most appropriate general classification is Regulatory Filings (RNS), which serves as a catch-all for significant, non-standardized corporate news releases.
2014-06-16 Swedish
Amerikanska läkemedelsmyndigheten (FDA) godkänner Eloctate(TM)
Regulatory Filings Classification · 95% confidence The document is titled "PRESSMEDDELANDE" (Press Release) and announces a significant event: the US FDA approval of a drug (Eloctate) by Sobi's partner, Biogen Idec. It details the implications of the approval, clinical trial data references, and future regulatory plans (EMA application). This format—a formal announcement of a key business/regulatory event, often released to the public and media—is characteristic of an Earnings Release (ER) or a general Regulatory Filing (RNS). Since it is not a full financial report (10-K, IR) or a transcript (CT), and it specifically announces a major regulatory milestone, it fits best as an Earnings Release (ER) if it were tied to a reporting period, or more generally, a Regulatory Filing (RNS) as it is a non-financial, material event announcement. Given the context of financial reporting databases, press releases announcing major drug approvals are often categorized as general regulatory announcements or material event disclosures. Since 'ER' usually implies financial results (quarterly/annual), and this is a specific regulatory/product update, 'RNS' (Regulatory Filings/General Announcement) is the most appropriate fallback for a material, non-financial press release. However, looking closely at the definitions, this is a material announcement that impacts the company's outlook and operations, similar to what might be included in an ER summary, but it is fundamentally a regulatory/product news announcement. Since it is not a formal financial report, and it is a specific, material announcement, RNS is the safest classification, although ER is plausible if the database groups all major news releases here. Given the focus on FDA approval, it is a regulatory event announcement. I will classify it as RNS as it is a general regulatory announcement that doesn't fit the specific financial report codes.
2014-06-09 Swedish
The US Food and Drug Administration (FDA) approves Eloctate(TM)
Regulatory Filings Classification · 94% confidence The document announces a significant regulatory event: the US Food and Drug Administration (FDA) approval of a drug (Eloctate™) for haemophilia A. It details the drug's mechanism, clinical trial data (A-LONG, Kids A-LONG), and future regulatory plans (Europe filing). This content is characteristic of a press release or an initial announcement of a major business/regulatory development, rather than a comprehensive annual report (10-K), a quarterly report (IR), or a formal legal filing. Since it is an announcement of a key event (drug approval) and includes management commentary and product details, it aligns best with an Earnings Release (ER) if it were tied to financial results, but given the specific nature of a regulatory approval announcement that isn't explicitly a financial earnings report, it falls under the general category of important corporate news. However, looking at the definitions, 'ER' is for periodical financial results. This document is a specific regulatory/product milestone announcement. In the absence of a specific 'Regulatory Approval Announcement' code, and given that it is a substantial announcement of a major event, it is closest to an Earnings Release (ER) in function (announcing a major positive event) or potentially a Regulatory Filing (RNS) as a general announcement. Since it is a detailed press release announcing a major milestone, and not a short notice, it is more substantial than a simple RNS. Given the options, and recognizing that major product approvals often accompany or are treated similarly to earnings announcements in terms of market impact, ER is a possibility, but the core subject is regulatory/product news. If we must choose from the list, and it's not a formal financial report, it functions as a significant corporate update. Since it is not a short notice (length is 6189 chars) and is the primary source of the information (not just announcing another document), it is not RPA or RNS by the 'Menu vs Meal' rule. It is a detailed announcement. Given the lack of a specific 'Product Approval' code, and its nature as a detailed corporate update, it is most likely intended to be classified as a general Regulatory Filing (RNS) if it doesn't fit the financial report categories, or potentially an Investor Presentation (IP) if it were structured as slides, which it is not. Based on the content being a press release detailing a regulatory event, RNS (Regulatory Filings - general regulatory announcements and fallback) is the most appropriate general category when specific codes like 'Product Approval' are missing.
2014-06-09 English
Sobi Establishes North American Office in Massachusetts
Regulatory Filings Classification · 95% confidence The document is a press release announcing that Sobi is establishing its North American office in Massachusetts. It details the location, timing, and quotes from the CEO and the Governor/Life Sciences Center. This type of announcement, which concerns operational changes, expansion, or strategic location decisions, does not fit neatly into the specific financial reporting categories (like 10-K, ER, IR, DIV, etc.). It is a general corporate announcement. Since it is not a formal regulatory filing like a Director's Dealing (DIRS) or Major Shareholding (MRQ), and it is not a transcript (CT) or a presentation (IP), the most appropriate fallback category is Regulatory Filings (RNS), which serves as a general category for miscellaneous corporate announcements that are released publicly.
2014-06-05 English

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