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    Norra Stationsgatan 93A, Sweden


    +46 8 697 20 00
  • Gerard Tobin

    Head of Investor Relations


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    New data for emapalumab in the treatment of macrophage activation syndrome to be presented at the ACR conference

    Sobi® (STO: SOBI) today announced that new research showing the effect of emapalumab in patients with macrophage activation syndrome (MAS) in Still’s disease, including systemic juvenile idiopathic arthritis (sJIA) and adult-onset still’s disease (AOSD) who had an inadequate response to high-dose glucocorticoids (GCs) will be presented at the American College of Rheumatology (ACR) Convergence in Washington D.C. The data were pooled from two open-label, single-arm interventional studies, the phase 3 NI-0501-14 study [EMERALD; NCT05001737 

    Pivotal VALIANT results presented at Kidney Week show pegcetacoplan treatment effect in patients with C3G / primary IC-MPGN

    · Statistically significant 68% (p<0.0001) proteinuria reduction compared to placebo, with reduction observed as early as Week 4 · All secondary endpoints favoured treatment with pegcetacoplan, including: · Stabilised eGFR, a key measure of kidney function · 71% of patients achieved zero C3c staining intensity, indicating clearance of C3c deposits · Results consistent across subgroups including C3G and primary IC-MPGN, adolescent and adult patients, and native and post-transplant kidneys Sobi® (STO: SOBI) and Apellis Pharmaceuticals, Inc. today announced that detailed

    Invitation: Sobi’s Aspaveli® and the Phase 3 VALIANT data in Nephrology call

    VALIANT Phase 3 results after presentation at ASNInvestors, analysts, and members of the media are invited to a conference call on Tuesday, October 29th, at 12:00 CET, 11:00 GMT, and 07:00 EDT. The call will include a presentation of results and insights from management and Professor Fadi Fakhouri following the American Society of Nephrology (ASN) and a Q&A session.   The presentation can be followed live here  or afterwards on sobi.com. The slides will be made available on sobi.com 

    Sobi Q3 2024 report: Strong growth and significant pipeline momentum

    Swedish Orphan Biovitrum AB (publ) (Sobi®) today announced its report for the third quarter 2024Third Quarter 2024 •         Total revenue increased 33 per cent, 39 per cent at constant exchange rates, (CER)1, to SEK 6,894 M (5,168) •         Haematology revenue increased 18 per cent at CER to SEK 4,000 M (3,484), mainly driven by strong sales of Doptelet[®] of SEK 1,039 M (650), sales of Aspaveli[®]/Empaveli[®] of SEK 270 M (169) and launch sales of Altuvoct[®] of SEK 129 M (—)  •         Immunology revenue increased 96 per cent at CER to SEK 2,583 M (1,400), driven by strong

    Invitation: Sobi’s Q3 2024 report

    Sobi plans to publish its report for the third quarter of 2024 on 24 October 2024 at 08:00 CEST.Investors, analysts, and the media are invited to a conference call on the same day at 14:00 CEST, 13:00 BST, and 08:00 EDT. The call will include a presentation of the results and a Q&A session.   The presentation can be followed live here  or afterwards on sobi.com. The slides will be made available on sobi.com  before the conference call.   To participate in the conference call, please

    New number of shares and votes in Sobi

    As per 30 September 2024, the total number of shares in Swedish Orphan Biovitrum AB (publ) (Sobi®) amounts to 356,000,049 shares. All shares are common shares. The total number of votes is 356,000,049. The increase in the number of shares and votes results from issues of 1,641,103 class C shares. The class C shares have been issued for the purpose of ensuring fulfilment of commitments under the long-term incentive programmes and have by virtue of the conversion clause in the articles of association been converted to common shares. As per 30 September 2024 the company holds 12,564,213 common

    Sobi® and Enable Injections announce agreement to develop and distribute Aspaveli® in combination with enFuse® in Sobi territories

    Sobi® (STO: SOBI) and Enable Injections, Inc. (Enable) today announced an international development and distribution agreement across Sobi territories for the enFuse® Injector, for the subcutaneous delivery of Aspaveli® (pegcetacoplan).     The enFuse Injector, to be produced by Enable and distributed by Sobi, is designed to streamline and improve patients’ self-administration experience with minimal disruption to their daily lives via the use of enFuse technology. This allows wearable, hidden needle drug delivery through a simple injection under the skin.   "We are dedicated to

    Sobi has completed issues of class C shares

    The Annual General Meeting of Swedish Orphan Biovitrum AB (publ) (Sobi®) on 14 May 2024 resolved on directed issues of redeemable and convertible class C shares and to authorise the Board of Directors to resolve on the repurchase of all issued class C shares through an acquisition offer directed to all owners of class C shares in Sobi. The Board of Directors of Sobi has, as previously communicated, on 15 July resolved to, conditional upon subscription and payment from Svenska Handelsbanken AB, repurchase all issued class C shares, to secure Sobi’s obligations under the outstanding incentive

    Sobi and Apellis announce positive topline results from phase 3 VALIANT study of pegcetacoplan in C3G and primary IC-MPGN

    · Met the primary endpoint, achieving statistically significant 68% (p<0.0001) reduction in proteinuria compared to placebo in a broad study population   · Positive results consistent across all subgroups, including C3G and IC-MPGN, adolescent and adult patients, and native and post-transplant kidneys   · Demonstrated favourable safety, consistent with established profile   · Companies plan to submit data for regulatory approval in the US and EU   Sobi® (STO: SOBI) and Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced positive topline results from

    NEJM publishes ALTUVOCT® phase 3 XTEND-Kids results highlighting treatment potential for children with severe haemophilia A

    · XTEND-Kids is the first assessment of once-weekly ALTUVOCT® prophylaxis in previously treated children · Results indicate highly effective bleed protection in children under 12 years of age with severe haemophilia A Sobi® today announced the publication of full results from the Phase 3 XTEND-Kids study in The New England Journal of Medicine (NEJM) confirming the safety and efficacy profile of ALTUVOCT® (efanesoctocog alfa), in children younger than 12 years old with severe haemophilia A. The study demonstrated that fixed-dose once-weekly prophylaxis with ALTUVOCT, a new class of

    Sobi Q2 2024 report: Strong delivery driven by robust portfolio performance

    Swedish Orphan Biovitrum AB (publ) (Sobi®) today announced its report for the second quarter 2024Second Quarter 2024   •          Total revenue increased 12 per cent, 11 per cent at constant exchange rates, (CER)1, to SEK 5,442 M (4,872) •         Haematology revenue increased 13 per cent at CER to SEK 3,866 M (3,430), reflecting growth in all medicines, mainly driven by strong sales of Doptelet® excluding sales to China of SEK 928 M (567), sales of Vonjo® of SEK 347 M (36) and sales of Aspaveli®/Empaveli® of SEK 251 M (144) •         Immunology revenue increased 7 per cent at

    The Board of Directors of Sobi exercises authorisation for repurchase of shares for the purpose of securing the company’s commitments under incentive programmes

    The Annual General Meeting of Swedish Orphan Biovitrum AB (publ) (Sobi[®]) on 14 May 2024, resolved – for the purpose of ensuring that the company can fulfil its commitments under the long-term incentive programmes resolved by the Annual General Meeting – on directed share issues of no more than 1,641,103 redeemable and convertible class C shares.The Annual General Meeting also resolved to authorise the Board of Directors to resolve on the repurchase of all issued class C shares by an offer directed to all holders of class C shares. Repurchase under this authorisation may be made on one or

    Invitation: Sobi’s Q2 2024 report

    Sobi plans to publish its report for the second quarter of 2024 on 16 July 2024 at 08:00 CEST.Investors, analysts and media are invited to participate in a conference call, which will include a presentation of the results and a Q&A session on the same day at 14:00 CEST.   The presentation can be followed live here  or afterwards on sobi.com. The slides will be made available on sobi.com before the conference call.   To participate in the conference call, please use the following dial-in details:

    Sobi initiates rolling biologics license application to FDA for SEL-212 for the potential treatment of chronic refractory gout

    Sobi® today announced the initiation of a rolling Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for SEL-212. The submission is based on the results of the DISSOLVE I and II pivotal studies. SEL-212 is an innovative biologic therapy in development for the treatment of chronic refractory gout, a debilitating condition characterised by the persistent and painful buildup of urate crystals in the joints.   This significant milestone follows the FDA’s Fast Track designation of SEL-212 in March 2024, underscoring the urgent need for new treatment options

    European Commission grants Sobi® Marketing Authorisation for ALTUVOCT™ for treatment of haemophilia A

    Sobi® today announced the European Commission has granted Marketing Authorisation for ALTUVOCT™ (efanesoctocog alfa), for the treatment and prevention of bleeds and perioperative prophylaxis in haemophilia A. ALTUVOCT is a high-sustained factor VIII replacement therapy for all ages and any disease severity. Children, adolescents, and adults can experience non-haemophilia factor VIII activity levels (above 40%) for a significant part of the week with once-weekly prophylaxis, reaching trough levels of 15% in adults and adolescents before the next dose. This results in significantly improved

    Sobi to present new haemophilia data at ISTH 2024

    Sobi® will present new scientific data related to haemophilia at ISTH 2024, the 32nd Congress of the International Society on Thrombosis and Haemostasis. This event, taking place from 22nd to 26th June, will be held both online and in Bangkok. Seven abstracts have been accepted for presentation (three posters and four oral). New long-term safety and efficacy data on efanesoctocog alfa and long-term efficacy data on Elocta will be presented further demonstrating Sobi's commitment to advancing standards of care in haemophilia A treatment.   “We are pleased to present new data at this

    Sobi to present new data across its haematology portfolio at the 2024 EHA congress

    Sobi® will present data at the EHA (European Haematology Association) hybrid congress, taking place in Madrid on the 13-16th June, highlighting the company’s dedication to advancing treatments for rare and debilitating haematological diseases. The congress will feature Sobi's latest advances in the treatment of immune thrombocytopenia (ITP), myelofibrosis, haemophilia A, and paroxysmal nocturnal haemoglobinuria (PNH).   “We look forward to sharing new data related to several of Sobi’s therapeutic areas at this year’s EHA congress,” said Lydia Abad-Franch, MD, Head of R&D and Medical

    Positive data from phase 2 NOBLE study of pegcetacoplan presented as late-breaker at ERA congress

    · Rapid reduction in disease activity seen at 12 weeks sustained at one year · 55% of patients showed zero C3c staining intensity, indicating that C3c deposits cleared · Highlighted as late-breaking oral presentation at the European Renal Association (ERA) Congress Sobi® and Apellis Pharmaceuticals, Inc. today announced positive one-year results from the phase 2 NOBLE study investigating systemic pegcetacoplan, a targeted C3 therapy, for the treatment of post-transplant recurrence of C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-

    Bulletin from Sobi’s Annual General Meeting (AGM)

    The Swedish Orphan Biovitrum AB (publ) (Sobi®) AGM was convened today on 14 May 2024. At the AGM, the shareholders, in accordance with the proposed resolutions, resolved as follows:Adoption of the profit and loss statements and balance sheet and discharge of liability The AGM adopted the income statements and the balance sheets and approved the proposal to carry forward the retained profits.   The Board members and the chief executive officer were discharged from liability for the financial year 2023.   Election of Board of Directors, remuneration to the Directors, election

    Sobi has completed SEK 3 billion senior bond issue

    Swedish Orphan Biovitrum AB (publ) (Sobi[®]) has successfully completed the inaugural issue of senior unsecured bonds of SEK 3 billion under its newly established MTN programme.The bonds are divided into three tranches where SEK 1.35 billion was issued with a tenor of 3 years and carries a floating rate of 3-months STIBOR + 1.35%, SEK 1.10 billion was issued with a tenor of 5 years and carries a floating rate of 3-months STIBOR + 1.75% and SEK 550 million was issued with a tenor of 5 years and carries a fixed rate of 4.515%.   The bond issue generated strong investor interest and was

    Aspaveli® (pegcetacoplan) approved in Europe for use among treatment naïve adult patients with PNH

    Sobi® today announced that the European Commission (EC) has approved an indication extension for Aspaveli® (pegcetacoplan) for treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia.Aspaveli is already approved in Europe for the treatment of adults with PNH who are anaemic after treatment with a C5 inhibitor for at least three months. Aspaveli is now the first C3 inhibitor approved for first-line treatment of PNH in Europe, offering effective outcomes by improving haemoglobin and other clinical markers due to its unique mode of action.

    Sobi® receives positive CHMP opinion recommending approval of efanesoctocog alfa for once-weekly treatment of haemophilia A

    Sobi® today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending approval of efanesoctocog alfa, for the treatment and prevention of bleeds and perioperative prophylaxis in haemophilia A. Efanesoctocog alfa is a once-weekly and high-sustained factor VIII replacement therapy for patients of all ages and any disease severity.   Efanesoctocog alfa provides children, adolescents and adults with normal to near-normal factor VIII activity levels (above 40%) for a significant part of the week with once-

    Sobi establishes MTN programme with a framework amount of SEK 10 billion, publishes a base prospectus

    Swedish Orphan Biovitrum AB (publ) (Sobi[®]) has established a medium term note programme with a framework amount of SEK 10 billion or the equivalent thereof in EUR (the “MTN Programme”).For this purpose, Sobi has prepared a base prospectus, which has today been approved and registered by the Swedish Financial Supervisory Authority (Sw. Finansinspektionen). The base prospectus will be made available on Sobi’s website.   SEB has been appointed arranger of the MTN Programme and will also act as dealer together with Danske Bank, Nordea and Svenska Handelsbanken. Mannheimer Swartling

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