US/UK/Canada

Share

Contacts

  • Visiting address

    Norra Stationsgatan 93A, Sweden


    +46 8 697 20 00
  • Gerard Tobin

    Head of Investor Relations


    • Pick a time period -
    Tags ( Active)

    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

    Sobi Q1 2024 report: Strong sales reflecting the strength of the portfolio

    Swedish Orphan Biovitrum AB (publ) (Sobi®) today announced its report for the first quarter 2024First Quarter 2024 •          Total revenue increased 19 per cent, 20 per cent at constant exchange rates, (CER)1, to SEK 6,256 M (5,239) •         Haematology revenue increased 46 per cent at CER to SEK 4,075 M (2,815), reflecting growth in all medicines, mainly driven by strong sales of Doptelet® of SEK 756 M (475), sales of Vonjo® of SEK 320 M (—), and sales of Aspaveli®/Empaveli® of SEK 240 M (95) •         Immunology revenue decreased 11 per cent at CER to SEK 1,908 M (2,151),

    Invitation: Sobi’s Q1 2024 report

    Sobi plans to publish its report for the first quarter of 2024 on 25 April 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 16:00 CEST.   The presentation can be followed live here  or afterwards on sobi.com. The slides will be made available on sobi.com prior to the conference call.   To participate in the conference call, please use the following dial-in details: Sweden:

    Notice of Annual 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 Annual General Meeting (the “Meeting”), to be held on Tuesday, 14 May 2024 at 15.00 at IVA Konferenscenter, Grev Turegatan 16, Stockholm, Sweden.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 to attend the meeting venue in person or by proxy must · be listed as a shareholder in

    Sobi publishes Annual and sustainability report for 2023

    Swedish Orphan Biovitrum AB (publ) (Sobi[®]) today published its Annual and sustainability report for 2023. Inspired by caring and powered by science, the integrated report summarises business and strategy, financial performance, and work on sustainability.The report includes the audited Annual report and the Sustainability report, which is Sobi’s statutory sustainability report in accordance with the Swedish Annual Accounts Act and based on GRI Standards 2021. The Sustainability report includes Sobi’s Task Force on Climate-related Financial Disclosures (TCFD) report and the EU taxonomy

    Sobi announces positive results from phase 3 study of Doptelet® for treatment of children and adolescents with ITP

    · The primary endpoint was met, confirming the efficacy and safety of avatrombopag (Doptelet®) in treating children and adolescents with ITP · avatrombopag is widely approved for the treatment of adults with ITP; AVA-PED-301 data will support global regulatory filings to expand to children and adolescents with ITPSobi® today announced positive results from the AVA-PED-301 study (NCT04516967 ), evaluating the efficacy and safety of avatrombopag (Doptelet) for the treatment of

    Sobi and Handok establish joint venture for rare disease business in South Korea

    · A long-term strategic partnership model is being developed through a joint venture. · The joint venture will commercialise and distribute selected Sobi medicines in South KoreaSobi® and Handok will establish a joint venture for the rare disease business in South Korea. The joint venture, due for incorporation in the first half of this year, is expected to enhance the Sobi and Handok collaboration. Strengthening their position in the rare disease business, Handok and Sobi aim to develop, commercialise and distribute Sobi’s innovative medicines in South Korea.Serving patients in South

    There are no items matching the current filter
    There are no more items matching the current filter
    Back to top

    Subscribe