Swedish Orphan Biovitrum AB

STOCKHOLM, Nov. 5, 2025 /PRNewswire/ -- Sobi® (STO: SOBI) today announced that data on Aspaveli/Empaveli in C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) and NASP in uncontrolled gout will be presented at ASN Kidney Week 2025, 5-9 November in Houston, Texas. In total, the company will be present 1 oral and 6 poster presentations for Aspaveli/Empaveli, as well as 3 poster presentations for NASP. 

New one-year data reinforces the robust and sustained efficacy of Aspaveli/Empaveli (pegcetacoplan) in patients with C3G and primary IC-MPGN. 

"Patients on Aspaveli/Empaveli maintained proteinuria reduction, irrespective of taking immunosuppressants and independent of their baseline proteinuria levels. One third of patients achieved complete proteinuria remission compared to 3% for placebo at week 26. These benefits were maintained through one year, and patients who switched from placebo experienced similar improvements. This demonstrates the potential of Aspaveli/Empaveli to transform care for people living with these rare diseases, who have a high risk of kidney failure," said Lydia Abad-Franch, MD, Head of R&D and Medical Affairs, and Chief Medical Officer at Sobi.

Sobi will also present data showing NASP maintained stable renal function throughout the 6-month study period, with a higher proportion of patients experiencing improvement in CKD stage compared to placebo among those with uncontrolled gout and stage 3 chronic kidney disease. Additionally, NASP treatment led to a reduction in gout-related clinical manifestations and was generally well tolerated. 

Key data to be presented at ASN Kidney Week 2025 

About Aspaveli/Empaveli (pegcetacoplan)

Aspaveli/Empaveli (pegcetacoplan) is a targeted C3 and C3b therapy designed to regulate excessive activation of the complement cascade, part of the body's immune system, which can lead to the onset and progression of many serious diseases. It is the first treatment approved in the United States for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years of age and older, to reduce proteinuria. Aspaveli/Empaveli is also approved for the treatment of adults with paroxysmal nocturnal haemoglobinuria (PNH) in the United States, European Union, and other countries globally, and is under investigation for other rare diseases. 

About the VALIANT Study 

The VALIANT Phase 3 study (NCT05067127) was a randomised, placebo-controlled, double-blinded, multi-center study that evaluated efficacy and safety of Aspaveli/Empaveli (pegcetacoplan) in 124 patients who were 12 years of age and older with C3G or primary IC-MPGN. It is the largest single trial conducted in these populations and the only study to include paediatric and adult patients, with native or post-transplant kidneys. Study participants were randomised to receive Aspaveli/Empaveli or placebo twice weekly for 26 weeks. Following this 26-week randomised controlled period, patients were able to proceed to a 26-week open-label phase in which all patients received Aspaveli/Empaveli. The primary endpoint of the study was the log transformed ratio of urine protein-to-creatinine ratio (UPCR) at Week 26 compared to baseline. 

About C3 Glomerulopathy (C3G) and Primary Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) 

C3G and primary IC-MPGN are rare and debilitating kidney diseases that can lead to kidney failure. Excessive C3 deposits are a key marker of disease activity, which can lead to kidney inflammation, damage, and failure. Approximately 50% of people living with C3G and primary IC-MPGN suffer from kidney failure within five to 10 years of diagnosis, requiring a burdensome kidney transplant or lifelong dialysis therapy.1-3 Additionally, approximately 90% of patients who previously received a kidney transplant will experience disease recurrence.4 The diseases are estimated to affect 5,000 people in the United States and up to 8,000 in Europe.5   

About the Sobi and Apellis Collaboration 

Apellis and Sobi have global co-development rights for systemic pegcetacoplan. Sobi has exclusive ex-U.S. commercialization rights for systemic pegcetacoplan, and Apellis has exclusive U.S. commercialization rights for systemic pegcetacoplan and worldwide commercial rights for ophthalmological pegcetacoplan, including for geographic atrophy. 

About NASP

NASP is a novel investigational medicine designed to reduce serum uric acid (sUA) levels in people living with uncontrolled gout, potentially reducing harmful tissue urate deposits which when left untreated can lead to debilitating gout flares and joint deformity. NASP is administered every 4-weeks as a sequential, two-component, infusion therapy consisting of tolerogenic nanoencapsulated sirolimus (NAS) which mitigates the formation of anti-drug antibodies (ADAs) and a uricase, pegadricase (P), which reduces serum uric acid. ADAs develop due to unwanted immune responses to biologic medicines, reducing their efficacy and tolerability, which remains an issue across multiple therapeutic modalities and disease states including uncontrolled gout.

About Uncontrolled Gout

Gout is the most common form of inflammatory arthritis with more than 8.3 million people in the United States having been diagnosed. Gout is caused by high levels of uric acid in the body that accumulate around the joints and other tissues and can result in flares that cause intense pain. Approximately 200,000 people in the United States suffer from uncontrolled gout, with serum uric acid (sUA) levels above 6 mg/dL despite treatment with oral urate lowering therapies. This leads to debilitating flares and tophi. Elevated sUA levels have also been associated with diseases of the heart, vascular system, metabolism, kidney and joints.

Sobi®

Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. Sobi has approximately 1,900 employees across Europe, North America, the Middle East, Asia and Australia. In 2024, revenue amounted to SEK 26 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.

Contacts

For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here.

References

1. Smith RJH, et al. Nat Rev Nephrol. 2019;15(3):129-143.

2. Servais A, et al. Kidney Int. 2012;82(4):454-464.

3. Zand L, et al. J Am Soc Nephrol. 2014;25(5):1110-1117.

4. Tarragón, B, et al. C3 Glomerulopathy Recurs Early after Kidney Transplantation in Serial Biopsies Performed within the First 2 Years after Transplantation. Clinical Journal of the American Society of Nephrology. August 2024; 19(8)1005-1015. doi: 10.2215/CJN.0000000000000474.

5. Data on file using literature consensus.

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STOCKHOLM, July 15, 2025 /PRNewswire/ -- The Annual General Meeting of Swedish Orphan Biovitrum AB (publ) (Sobi®) on 8 May 2025, 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 1,412,788 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 several occasions until the Annual General Meeting 2026 and at a price of no less than 100 per cent and no more than 105 per cent of the quotient value of the share.

Today, the Board of Directors has resolved to, conditional upon subscription and payment by Svenska Handelsbanken AB, exercise the repurchase authorisation for the said purpose by repurchasing all issued class C shares against payment of 100 per cent of the quotient value of the share, corresponding to approximately SEK 0.55 per share. Repurchase of the class C shares may be effected during the period 16 July – 7 November 2025.

The company currently holds 11,377,680 own common shares and no own class C shares. Subsequently to the effected repurchase of class C shares above, all repurchased class C shares are intended to be converted to common shares, whereafter the number of own common shares will amount to 12,790,468.

Sobi

Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. Sobi has approximately 1,900 employees across Europe, North America, the Middle East, Asia and Australia. In 2024, revenue amounted to SEK 26 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.

Contacts

For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here.

Gerard Tobin

Head of Investor Relations

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