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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 2020-10-09 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 announces topline phase 3 data of avatrombopag for the treatment of Chemotherapy-Induced Thrombocytopenia
Regulatory Filings Classification · 95% confidence The document is explicitly titled "PRESS RELEASE" and announces "topline phase 3 data" regarding a clinical trial result (avatrombopag for CIT). This type of announcement, detailing key results, often before a full regulatory filing or comprehensive report, aligns best with an Earnings Release (ER) or a general Regulatory Filing (RNS). Since it is a specific announcement of clinical trial results and financial/operational updates (though not quarterly earnings figures), and it is not a transcript (CT), a formal annual report (10-K), or a presentation (IP), it functions as a material event disclosure. Given the options, 'ER' (Earnings Release) is often used broadly for material operational/clinical updates that impact investor perception, or 'RNS' (Regulatory Filings) as a catch-all. Because it is a press release announcing a significant operational/clinical milestone (even if the result was negative), it is most closely aligned with the function of an Earnings Release (ER) which disseminates key performance/operational news to the market, or RNS. Given the context of a clinical trial result announcement, ER is a strong candidate if the company uses this format for all material news, but RNS is the safest fallback for non-standard material disclosures. However, many companies issue press releases for clinical trial updates which function similarly to earnings announcements in terms of market impact. Since it is a direct announcement of results and not just a notice that a report is coming (RPA), I will classify it as an Earnings Release (ER) as it conveys the core operational news, or RNS. Given the specific nature of clinical trial results, RNS is often the most appropriate category for non-standard material disclosures not covered by ER/10-K/IR. I will select RNS as the most appropriate general regulatory disclosure category for this specific clinical trial update press release.
2020-10-09 English
Sobi presenterar topline-resultat från fas-3 studien med avatrombopag för behandling av cytostatikainducerad trombocytopeni
Regulatory Filings Classification · 99% confidence The document is titled "PRESSMEDDELANDE" (Press Release) and is dated October 9, 2020. It announces the topline results from a Phase 3 clinical study for the drug avatrombopag concerning chemotherapy-induced thrombocytopenia (CIT). This type of announcement, detailing key financial or operational results (in this case, clinical trial outcomes impacting future revenue/strategy) released via a press release, typically falls under an Earnings Release (ER) if it were quarterly results, or a general Regulatory Filing (RNS) if it's a specific operational update not covered by other categories. Since it is a specific announcement of clinical trial results and management commentary, and not a full financial report (10-K, IR) or a transcript (CT), it is best classified as an Earnings Release (ER) as it serves the function of releasing period-specific performance information, even if clinical rather than purely financial. Given the context of a bio-pharma company announcing trial results, ER is the closest fit for a material operational update. Alternatively, since it is a specific, non-standard announcement, RNS (Regulatory Filings) is also a strong candidate, but ER is often used for material operational updates that impact investor outlook, similar to earnings. Considering the content is a major operational update (clinical trial results) released via a press release, ER is chosen over the general RNS fallback.
2020-10-09 Swedish
Sobi och Selecta Biosciences presenterar topline-data från fas 2-studien med SEL-212 COMPARE som stödjer potentialen att nå viktig klinisk förbättring hos patienter med kronisk gikt
Earnings Release Classification · 99% confidence The document is titled "PRESSMEDDELANDE" (Press Release) and is dated September 30, 2020. It announces "topline-data" from a Phase 2 clinical study (COMPARE) for a drug candidate (SEL-212) and discusses future plans, including initiating a Phase 3 program (DISSOLVE) and filing a BLA in Q1 2023. This content structure—announcing key clinical trial results and future regulatory/development milestones in a press release format—is characteristic of an Earnings Release (ER) or a general announcement. Since it is specifically announcing the results of clinical trials and development progress, it is best classified as an Earnings Release (ER) as it provides the key financial/operational performance highlights (clinical trial success/failure) for the period, even though it's not a standard quarterly financial report. It is not a full Annual Report (10-K), an Interim Report (IR), or a specific regulatory filing like DIRS or DIV. It is a direct announcement of operational results, fitting the ER definition best among the choices. FY 2020
2020-09-30 Swedish
Sobi and Selecta Biosciences announce topline data of SEL-212 from the phase 2 COMPARE study supporting the potential for important clinical improvement in patients with Chronic Refractory Gout
Earnings Release Classification · 95% confidence The document is explicitly titled "PRESS RELEASE" and announces "topline data" from a Phase 2 clinical study (COMPARE study) comparing two treatments for Chronic Refractory Gout. It details key efficacy and safety results, quotes executives and investigators, and mentions future plans (Phase 3 DISSOLVE program, BLA filing timeline). This structure—a summary of recent results intended for immediate public dissemination—is characteristic of an Earnings Release (ER) or a general press release announcing significant operational/clinical milestones. Since the document focuses entirely on the *results* of a clinical trial and not a comprehensive annual financial review (10-K) or a formal quarterly report (IR), the most appropriate classification among the provided options is Earnings Release (ER), as clinical trial results often accompany or substitute for traditional earnings announcements in biotech/pharma, or it could be classified as a Regulatory Filing (RNS) if no other category fits. Given the focus on announcing key performance indicators (efficacy data) and future guidance, ER is a strong fit, although it is not strictly an 'earnings' report. However, since it is a major announcement of operational/clinical performance, and not a formal regulatory filing like a 10-K or IR, and it is not a short announcement pointing to an attached report (RPA), ER is the best fit for a major performance update. If this were purely a regulatory filing announcement without performance data, RNS would be considered. Since it contains substantial performance data, ER is chosen. FY 2020
2020-09-30 English
Ändring av antalet aktier och röster i Swedish Orphan Biovitrum AB (publ)
Share Issue/Capital Change Classification · 100% confidence The document is a press release from Swedish Orphan Biovitrum AB (Sobi) announcing a change in the total number of shares and votes due to a new share issue (emission of C-shares). This type of announcement, which details changes in share capital or share counts, falls under the category of share issues and capital changes.
2020-09-30 Swedish
New number of shares and votes in Swedish Orphan Biovitrum AB (publ)
Share Issue/Capital Change Classification · 100% confidence The document is a press release announcing a change in the total number of shares and votes in Swedish Orphan Biovitrum AB due to an issue of class C shares for incentive programs. This falls under the category of share capital changes or share issues, which is explicitly defined as 'SHA'.
2020-09-30 English

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