STOCKHOLM, Nov. 11, 2024 /PRNewswire/ -- 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.

STOCKHOLM, Nov. 11, 2024 /PRNewswire/ -- 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.

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.

STOCKHOLM, Nov. 4, 2024 /PRNewswire/ -- 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 from senior positions in the international pharmaceutical industry. Most recently he served as Chief Executive Officer and Board Director of Mirati Therapeutics Inc and prior to that as Chief Executive Officer of FerGene Inc and Ipsen SA. He has also held senior executive positions at Baxalta Inc, Endocyte Inc, Novartis Pharmaceuticals and Johnson & Johnson.

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.

STOCKHOLM, Nov. 4, 2024 /PRNewswire/ -- 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 from senior positions in the international pharmaceutical industry. Most recently he served as Chief Executive Officer and Board Director of Mirati Therapeutics Inc and prior to that as Chief Executive Officer of FerGene Inc and Ipsen SA. He has also held senior executive positions at Baxalta Inc, Endocyte Inc, Novartis Pharmaceuticals and Johnson & Johnson.

STOCKHOLM, Oct. 30, 2024 /PRNewswire/ -- 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] and NI-0501-06 [NCT03311854], including 39 patients with MAS.   

STOCKHOLM, Oct. 30, 2024 /PRNewswire/ -- 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] and NI-0501-06 [NCT03311854], including 39 patients with MAS.   

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 depositsResults consistent across subgroups including C3G and primary IC-MPGN, adolescent and adult patients, and native and post-transplant kidneys

STOCKHOLM, Oct. 27, 2024 /PRNewswire/ -- Sobi® (STO: SOBI) and Apellis Pharmaceuticals, Inc. today announced that detailed data from the phase 3 VALIANT study were presented as an oral presentation during the High-Impact Clinical Trials session at the 2024 American Society of Nephrology (ASN) Kidney Week. The results highlighted the potential of systemic pegcetacoplan treatment in patients with C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), which are rare, debilitating kidney diseases.

STOCKHOLM, Oct. 25, 2024 /PRNewswire/ --

VALIANT Phase 3 results after presentation at ASN

Investors, 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 before the conference call.

STOCKHOLM, Oct. 24, 2024 /PRNewswire/ -- Swedish Orphan Biovitrum AB (publ) (Sobi®) today announced its report for the third quarter 2024

Third 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 Beyfortus® royalty of SEK 1,478 M (263) and sales of Kineret® of SEK 699 M (600)Revenue from medicines in the strategic portfolio* grew by 113 per cent at CER to SEK 3,830 M (1,924)The adjusted EBITA margin1,2 was 43 per cent (30), excluding items affecting comparability (IAC)2. EBITA was SEK 2,923 M (1,443), corresponding to a margin of 42 per cent (28). EBIT was SEK 2,038 M (547)Earnings per share (EPS) before dilution was SEK 4.27 (0.30). Adjusted EPS before dilution1 was SEK 4.36 (0.54). Cash flow from operating activities was SEK 1,201 M (1,058)In August, Sobi and Apellis Pharmaceuticals announced positive topline results from the Phase 3 VALIANT study of pegcetacoplan in C3G and primary IC-MPGN

STOCKHOLM, Oct. 24, 2024 /PRNewswire/ -- Swedish Orphan Biovitrum AB (publ) (Sobi®) today announced its report for the third quarter 2024

Third 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 Beyfortus® royalty of SEK 1,478 M (263) and sales of Kineret® of SEK 699 M (600)Revenue from medicines in the strategic portfolio* grew by 113 per cent at CER to SEK 3,830 M (1,924)The adjusted EBITA margin1,2 was 43 per cent (30), excluding items affecting comparability (IAC)2. EBITA was SEK 2,923 M (1,443), corresponding to a margin of 42 per cent (28). EBIT was SEK 2,038 M (547)Earnings per share (EPS) before dilution was SEK 4.27 (0.30). Adjusted EPS before dilution1 was SEK 4.36 (0.54). Cash flow from operating activities was SEK 1,201 M (1,058)In August, Sobi and Apellis Pharmaceuticals announced positive topline results from the Phase 3 VALIANT study of pegcetacoplan in C3G and primary IC-MPGN

STOCKHOLM, Oct. 9, 2024 /PRNewswire/ --

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 use the following dial-in details:Sweden: +46 8 5051 0031United Kingdom: +44 207 107 06 13United States: +1 631 570 56 13For other countries, please find the details here.

STOCKHOLM, Sept. 30, 2024 /PRNewswire/ -- 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 shares.

STOCKHOLM, Sept. 30, 2024 /PRNewswire/ -- 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 shares.

STOCKHOLM, Sept. 12, 2024 /PRNewswire/ -- 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.

STOCKHOLM, Aug. 29, 2024 /PRNewswire/ -- 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 programmes. Svenska Handelsbanken AB has today subscribed for all 1,641,103 issued class C shares and the new share issues are therefore completed.

STOCKHOLM, Aug. 29, 2024 /PRNewswire/ -- 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 programmes. Svenska Handelsbanken AB has today subscribed for all 1,641,103 issued class C shares and the new share issues are therefore completed.

Met the primary endpoint, achieving statistically significant 68% (p<0.0001) reduction in proteinuria compared to placebo in a broad study populationPositive results consistent across all subgroups, including C3G and IC-MPGN, adolescent and adult patients, and native and post-transplant kidneysDemonstrated favourable safety, consistent with established profileCompanies plan to submit data for regulatory approval in the US and EU

STOCKHOLM, Aug. 8, 2024 /PRNewswire/ -- Sobi® (STO: SOBI) and Apellis Pharmaceuticals, Inc. (NASDAQ: APLS) today announced positive topline results from the Phase 3 VALIANT study investigating systemic pegcetacoplan in patients with C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), which are rare kidney diseases with no approved treatments.

Met the primary endpoint, achieving statistically significant 68% (p<0.0001) reduction in proteinuria compared to placebo in a broad study populationPositive results consistent across all subgroups, including C3G and IC-MPGN, adolescent and adult patients, and native and post-transplant kidneysDemonstrated favourable safety, consistent with established profileCompanies plan to submit data for regulatory approval in the US and EU

STOCKHOLM, Aug. 8, 2024 /PRNewswire/ -- Sobi® (STO: SOBI) and Apellis Pharmaceuticals, Inc. (NASDAQ: APLS) today announced positive topline results from the Phase 3 VALIANT study investigating systemic pegcetacoplan in patients with C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), which are rare kidney diseases with no approved treatments.