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  • Gerard Tobin

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    Sobi's full year 2024 revenue higher than previous estimate

    Swedish Orphan Biovitrum AB (publ) (Sobi®) (STO:SOBI) announces today that revenue for the full year 2024 was higher than previous estimate. Full-year revenue was approximately SEK 26,000 M, representing approximately 19% growth at constant exchange rate (CER) (1). Adjusted EBITA margin (1,2) was in the mid-30s per cent of revenues.The main reasons for the increased revenue are higher sales than expected in Q4 across the Haemophilia portfolio and for Kineret. · Altuvoct: Higher than expected rate of new patients switching to Altuvoct in markets where the product has been launched,

    Bulletin from Sobi’s Extraordinary General Meeting (EGM)

    The Swedish Orphan Biovitrum AB (publ) (Sobi®) EGM was convened today on 11 December 2024. In accordance with the Nomination Committee’s proposals, David Meek was elected as new member of the Board of Directors and Chair of the Board of Directors for the period until the end of the Annual General Meeting 2025.   Minutes with complete resolutions from the EGM will be available on the company’s website www.sobi.com no later than 25 December 2024.   Sobi Sobi® is a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating

    Sobi’s strength in haematology to be showcased at ASH 2024

    New data from Sobi® and partners will be presented at the 66th Annual Meeting of the American Society of Hematology (ASH) in San Diego, CA (USA) from the 7th - 10th of December 2024. During the meeting several analyses will be presented on haemophilia A, haemophagocytic lymphohistiocytosis (HLH), myelofibrosis, paroxysmal nocturnal haemoglobinuria (PNH), and immune thrombocytopenia (ITP). “Haemophilia A has a lasting impact on joint health and quality of life. At ASH 2024, three oral presentations will reveal important new data about long-term outcomes with ALTUVOCT® prophylaxis,” said

    Notice of Extraordinary General Meeting in Swedish Orphan Biovitrum AB (publ)

    The shareholders in Swedish Orphan Biovitrum AB (publ) (Sobi®) Reg. No. 556038-9321, are hereby summoned to the Extraordinary General Meeting (the “Meeting”), to be held on Wednesday, 11 December 2024 at 09.00 at the offices of Mannheimer Swartling Advokatbyrå, Norrlandsgatan 21, Stockholm, Sweden. Registration for the Meeting will begin at 08.30.The Board of Directors has decided that shareholders shall be able to exercise their voting rights at the Meeting also by postal voting.   Right to participate and registration (A) Participation at the meeting venue A person who wishes

    David Meek is proposed as new Chair of the Board of Directors of Sobi

    The Nomination Committee of Swedish Orphan Biovitrum AB (publ) (Sobi®) proposes that David Meek is elected as new Chair of the Board of Directors of Sobi. Sobi intends to convene an Extraordinary General Meeting to be held in December 2024.David Meek currently serves as a member of the Board of Directors of Cullinan Therapeutics, uniQure (Chair) and the University of Southern California School of Pharmacy and Pharmaceutical Sciences. He also has previous experience from board work in listed pharmaceutical companies and US and European trade associations. David Meek has extensive experience

    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-

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