Sobi to present new Aspaveli®/Empaveli® data at ASN Kidney Week 2026

Sobi will present seven new clinical studies on Aspaveli/Empaveli at ASN Kidney Week 2026.

What the company is saying

Sobi is highlighting its scientific presence at ASN Kidney Week 2026 with seven accepted abstracts on Aspaveli/Empaveli (pegcetacoplan), including two oral and five poster presentations. The company frames these as evidence of its commitment to generating real-world data and addressing rare kidney diseases, specifically C3G and IC-MPGN. The announcement emphasizes the breadth of clinical topics—longer-term outcomes, renal safety, treatment experience, and the phase IV PRISM-C3 study—without disclosing specific clinical results ahead of the conference. Lydia Abad-Franch, MD, Head of R&D and Medical Affairs and Chief Medical Officer, is quoted to reinforce the importance of long-term follow-up and adolescent patient data. Sobi also reiterates its regulatory achievements: Aspaveli/Empaveli is the first approved treatment for C3G or IC-MPGN in patients 12 and older in the United States, European Union, and other markets, and is approved for PNH in adults. The company details its global collaboration with Apellis (now part of Biogen), specifying Sobi's exclusive ex-U.S. commercialization rights and Apellis/Biogen's U.S. and ophthalmological rights. Sobi closes with scale metrics: approximately 2,000 employees worldwide and SEK 28 billion in revenue for 2025.

What the data suggests

The announcement confirms seven accepted presentations on Aspaveli/Empaveli at ASN Kidney Week 2026, including two oral presentations focused on 76-week outcomes in C3G and IC-MPGN, and five posters covering study design, renal safety, user experience, pharmacokinetics, and real-world effectiveness. The company discloses headline financials—SEK 28 billion in 2025 revenue and a workforce of about 2,000—but does not provide period-over-period comparisons, product-level breakdowns, or profitability metrics. Regulatory status is clear: Aspaveli/Empaveli is approved for C3G/IC-MPGN in patients 12+ and for PNH in adults in the U.S., EU, and other countries. The collaboration structure is explicit: Sobi holds exclusive ex-U.S. commercialization rights for systemic pegcetacoplan, while Apellis (now part of Biogen) retains U.S. and worldwide ophthalmological rights. No new clinical data are released; the actual results will be presented at the conference. The evidence supports Sobi's scientific engagement and product positioning, but does not allow assessment of clinical efficacy, commercial momentum, or financial trajectory beyond the topline revenue figure.

Analysis

The announcement is primarily factual, reporting the acceptance of seven abstracts for presentation at a major nephrology conference and summarizing the topics to be covered, including 76-week outcomes and real-world evidence for Aspaveli/Empaveli. Most claims are realised and supported by specific details (number of presentations, dates, regulatory approvals, and collaboration rights). The only forward-looking elements are statements about Sobi's ongoing commitment to evidence generation and the intent to present new data, but these are proportionate and not exaggerated. No large capital outlay or future financial benefit is claimed, and the only financial figure disclosed is past revenue. There is no narrative inflation or overstatement of clinical or commercial impact; the tone is positive but restrained. The absence of detailed clinical results is appropriate for a conference preview and does not constitute hype.

Risk flags

• ●The absence of specific clinical results in this announcement means investors cannot assess the magnitude or statistical significance of Aspaveli/Empaveli's 76-week outcomes until the conference. This creates uncertainty about the product's real-world impact and potential for label expansion or increased uptake.
• ●Sobi's topline revenue disclosure (SEK 28 billion in 2025) lacks context—no historical trend, segment breakdown, or margin information is provided. This limits visibility into the company's financial health, growth drivers, and the contribution of Aspaveli/Empaveli to overall performance.
• ●The collaboration with Apellis (now part of Biogen) splits commercialization rights, with Sobi holding only ex-U.S. systemic rights. This restricts Sobi's direct access to the largest pharmaceutical market and exposes the company to partner execution and strategic alignment risks.

Bottom line

Sobi is using ASN Kidney Week 2026 to showcase its ongoing research and regulatory positioning for Aspaveli/Empaveli, but has not disclosed any new clinical results or commercial milestones in this announcement. The company’s topline revenue (SEK 28 billion in 2025) and global workforce (about 2,000 employees) indicate scale, but without further financial detail or clinical data, investors cannot gauge the product’s commercial trajectory or the impact of upcoming presentations. The real test will come when the 76-week outcome data and other study results are made public at the conference. Until then, this update signals scientific momentum but provides no actionable evidence of clinical or financial upside. The key takeaway: watch for the actual clinical data from ASN Kidney Week to assess whether Aspaveli/Empaveli can drive meaningful growth for Sobi.

Announcement summary

(STO:SOBI) Sobi announced that seven abstracts on Aspaveli/Empaveli (pegcetacoplan) have been accepted for presentation at the American Society of Nephrology (ASN) Kidney Week 2026, held from 21–25 October in Denver, Colorado, USA. The program includes two oral presentations and five poster presentations, covering topics such as longer-term clinical outcomes, renal safety, treatment experience, and the phase IV PRISM-C3 study. The two oral presentations will report 76-week outcomes with Aspaveli/Empaveli in C3 glomerulopathy (C3G) and primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN), demonstrating maintenance of proteinuria reduction and eGFR stabilization, including a pediatric subgroup analysis from VALIANT and its VALE extension. Lydia Abad-Franch, MD, Head of R&D and Medical Affairs and Chief Medical Officer at Sobi, stated that longer-term follow-up is important for understanding treatment outcomes in C3G and primary IC-MPGN, and that the 76-week analyses, including adolescent patient findings, continue to build the evidence base for Aspaveli/Empaveli. Oral presentations are scheduled for October 22, 2026 (VALIANT+VALE Subgroup Analysis, 05:30 PM - 05:40 PM, Room 501, Convention Center) and October 24, 2026 (C3G or IC-MPGN, 05:50 PM - 06:00 PM, Mile High Ballroom 4A, Convention Center). Poster presentations include the PRESERVE-C3Tx Phase 3b pilot study design (October 22, 2026, 10:00 AM - 12:00 PM), renal safety of pegcetacoplan in PNH (October 23, 2026, 10:00 AM - 12:00 PM), user experience with the on-body injector (October 24, 2026, 10:00 AM - 12:00 PM), PK/PD and exposure–response analysis (October 24, 2026, 10:00 AM - 12:00 PM), and real-world effectiveness and safety in PRISM-C3, a multi-country phase 4 study (October 24, 2026, 10:00 AM - 12:00 PM). Aspaveli/Empaveli is a targeted C3 and C3b therapy designed to regulate excessive activation of the complement cascade and is the first treatment for C3G or IC-MPGN in patients 12 years and older approved in the United States, European Union, and other countries. It is also approved for adults with paroxysmal nocturnal haemoglobinuria (PNH) in the United States, European Union, and other countries. Sobi and Apellis (now part of Biogen) have global co-development rights for systemic pegcetacoplan, with Sobi holding exclusive ex-U.S. commercialization rights and Apellis (now part of Biogen) holding exclusive U.S. commercialization rights and worldwide rights for ophthalmological pegcetacoplan. Sobi employs approximately 2,000 people across Europe, North America, the Middle East, Asia, and Australia. In 2025, Sobi's revenue amounted to SEK 28 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm.

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