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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 2013-12-05 Earnings Release
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
Förebyggande injektioner av Alprolix(TM) motverkar effektivt blödningar hos patienter med hemofili B visar ny data som publiceras i den vetenskapliga tidsskriften New England Journal of Medicine
Earnings Release Classification · 95% confidence The document is a press release dated December 5, 2013, announcing the publication of detailed results from the Phase 3 B-LONG study of the drug candidate Alprolix (rFIXFc) in the New England Journal of Medicine (NEJM). It details clinical trial outcomes, safety profiles, and the significance of the findings for Hemophilia B treatment. This type of announcement, which releases key financial/clinical results and often precedes a formal filing or is a standalone release of results, fits best under the Earnings Release (ER) category, as it communicates period-specific performance/results, even though it is clinical data rather than quarterly revenue. However, given the specific focus on clinical trial results being published in a scientific journal, it is a form of results announcement. Since 'ER' is defined as 'Initial announcement of quarterly/periodical financial results (key highlights only)', and this is a major clinical result announcement, it is closer to an ER than other categories. If the document were the full scientific paper or a detailed regulatory submission, other codes might apply, but as a press release announcing the publication of results, ER is the most appropriate fit among the options provided for communicating key performance/result highlights. It is not a full Annual Report (10-K), an Audit Report (AR), or a Management Discussion (MDA) of financial statements. It is a results announcement. FY 2013
2013-12-05 Swedish
The New England Journal of Medicine publishes pivotal data demonstrating prophylactic infusions of Alprolix(TM) effectively controlled bleeding in haemophilia B patients
Earnings Release Classification · 95% confidence The document is a press release dated December 5, 2013, announcing the publication of pivotal Phase 3 study results (B-LONG) for the investigational therapy ALPROLIX in *The New England Journal of Medicine*. It details efficacy, safety, and dosing regimens, and discusses regulatory applications. This format—a formal announcement of key results and study details, often issued before or concurrently with a major regulatory filing or publication—is characteristic of an Earnings Release (ER) or a general announcement. Since it is not a full financial report (10-K or IR), a transcript (CT), or a specific regulatory filing form, and its primary purpose is to disseminate key performance/trial results to the market, it best fits the 'Earnings Release' category, which often covers significant operational or clinical milestones that impact financial outlook. Given the context of clinical trial results being published, it functions as a major operational update, similar to how an ER reports financial results. It is not a Report Publication Announcement (RPA) because it contains the substantive data summary, not just a notice that a report is available. FY 2013
2013-12-05 English
Sobis partner Biogen Idec avser att presentera fas-3 data om förlängd halveringstid av hemofiliproduktkandidater i barn vid det årliga ASH-mötet
Regulatory Filings Classification · 95% confidence The document is titled with a headline indicating an upcoming presentation of Phase 3 data at the annual ASH meeting (American Society of Hematology). It details specific presentation abstracts, dates, and times for posters and oral presentations related to their hemophilia drug candidates (rFVIIIFc and rFIXFc). The document is explicitly labeled as a 'PRESSMEDDELANDE' (Press Release) dated December 3, 2013, and includes standard sections like 'Om Sobi' and 'Om Biogen Idec'. This structure—announcing participation and presentation of clinical data at a major conference—is characteristic of an Earnings Release (ER) or a general announcement related to investor/research activities. Since it is a press release announcing future data presentation rather than the full financial results themselves (which would be an ER or IR), and it is not a transcript (CT) or a formal regulatory filing like 10-K, the most fitting category is Earnings Release (ER) as it serves to disseminate key operational/clinical updates to the market, or potentially Regulatory Filing (RNS) if it were purely informational. Given the focus on clinical data presentation at a major medical conference, which is often timed around financial reporting cycles or used to generate investor interest, ER is a strong candidate, but since it's primarily an announcement about *future* presentations, it functions as a general corporate update. However, looking at the definitions, it is not a formal 'Interim Report' (IR) or 'Annual Report' (10-K). It is a press release announcing clinical data to be presented. This type of announcement, detailing operational/research milestones, often falls under the general umbrella of investor communication. Given the options, and recognizing it's a formal announcement of corporate news, 'ER' (Earnings Release, often used broadly for key results announcements) or 'RNS' (Regulatory Filings/General Announcement) are possibilities. Since it's a press release detailing specific clinical milestones and future presentations, it aligns best with the function of an Earnings Release (ER) which communicates key operational highlights, even if not strictly quarterly financials. If it were purely a notice about a report being available, RPA would apply, but this contains substantive information about the data itself. I will classify it as an Earnings Release (ER) as it is a press release disseminating key operational/clinical progress information to the market.
2013-12-03 Swedish
Sobi's partner Biogen Idec to present phase 3 data on prolonged half-life of Haemophilia candidates in young children at annual ASH meeting
Regulatory Filings Classification · 99% confidence The document is explicitly titled with "PRESS RELEASE" multiple times and contains an announcement about data presentation at an upcoming scientific meeting (ASH). It details scientific findings, study names (Kids A-LONG, B-LONG), and provides contact information for media and investor relations. This structure is characteristic of an Earnings Release (ER) or a general press announcement regarding corporate/product updates, rather than a comprehensive regulatory filing (like 10-K or IR) or a specific shareholder communication (like DEF 14A or AGM-R). Since it announces key data and is structured as a press release, the most appropriate classification is Earnings Release (ER), which often covers significant operational or clinical milestones, even if it's not strictly quarterly financial results.
2013-12-03 English
Sobi's partner Biogen Idec receives notification from FDA of PDUFA date extension for ALPROLIX(TM)
Regulatory Filings Classification · 95% confidence The document is explicitly titled "PRESS RELEASE" and announces a specific corporate event: the extension of a PDUFA date by the FDA for a partner's drug application (ALPROLIX). It contains key details about the regulatory process, the reason for the extension (submission of additional information), and background information on the drug and the companies involved (Sobi and Biogen Idec). This format—a brief, timely announcement of a specific operational or regulatory event, often released to the public via press wire—is characteristic of an Earnings Release (ER) or a general Regulatory Filing (RNS). Since it is not a comprehensive financial report (like 10-K or IR), nor a transcript (CT), nor a presentation (IP), and it details a specific regulatory/operational update, it fits best as an Earnings Release (ER) if it were tied to a reporting period, or RNS if it's purely operational/regulatory news. Given the context of financial reporting databases, press releases announcing key operational milestones or regulatory updates that are not full financial reports often fall under ER or RNS. Since this is a specific, non-financial-result-focused regulatory update, RNS (Regulatory Filings/General Announcement) is the most appropriate fallback, although ER is sometimes used for non-quarterly operational news. However, RNS is the designated category for general regulatory announcements that don't fit elsewhere. The document length (5014 chars) is substantial for a simple RPA, suggesting it contains substantive information rather than just linking to a report.
2013-12-02 English
Sobis partner Biogen Idec har fått besked av FDA om förskjuten tidslinje för ALPROLIX(TM) i USA
Regulatory Filings Classification · 95% confidence The document is titled "PRESSMEDDELANDE" (Press Release) and announces a specific event: the FDA delaying the PDUFA review date for a drug application (ALPROLIX) in partnership with Biogen Idec. This is a time-sensitive, material update concerning regulatory progress and product development, but it is not a comprehensive financial report (like 10-K or IR), a transcript (CT), or a formal dividend/share change notice. It functions as a general corporate announcement regarding regulatory affairs. Since it is a specific announcement that doesn't fit the highly specialized categories like DIRS, DIV, or CAP, the most appropriate general category for significant, non-financial regulatory updates that are not formal SEC filings is Regulatory Filings (RNS), which serves as a fallback for miscellaneous announcements.
2013-12-02 Swedish

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