Biogen Inc.

NASDAQ Global Select
Back to all articles
Slightly Bullish +25

Biogen Announces Upcoming Kidney Presentations at European Renal Association and American Transplant Congresses

📅 Biogen announced on June 3, 2026, that fourteen abstracts from its nephrology portfolio have been accepted for presentation at the 63rd European Renal Association Congress (ERA) and the 2026 American Transplant Congress (ATC).

🏥 The presentations will highlight data from EMPAVELI® (pegcetacoplan) and investigational felzartamab across two key medical congresses.

🗣️ Daniel Quirk, MD, Chief Medical Officer at Biogen, stated that the company's presence underscores momentum in its broadened nephrology portfolio.

📍 The ERA Congress will take place from June 3-6 in Glasgow, Scotland, featuring new post-hoc analyses from the pivotal Phase 3 VALIANT study for EMPAVELI.

🔬 Presentations at ERA will also showcase long-term extension VALE study data showing sustained efficacy and safety of EMPAVELI over one year in patients with C3 glomerulopathy or primary immune-complex membranoproliferative glomerulonephritis.

🤝 EMPAVELI presentations at ERA will be made in collaboration with Sobi, which retains commercial rights to the drug outside the U.S.

📍 The ATC will take place from June 20-24 in Boston, Massachusetts, featuring additional analyses of the Phase 2 felzartamab trial in antibody-mediated rejection (AMR).

🧬 Felzartamab is an investigational therapeutic human monoclonal antibody directed against CD38, designed to selectively deplete CD38+ plasma cells.

📊 ATC presentations will include a sponsored Symposium on emerging biomarkers for early identification and monitoring of transplant rejection.

🩺 The symposium will illustrate the role of CD38+ cells in AMR and microvascular inflammation (MVI).

🔄 A presentation at ATC will share pooled data from two studies assessing EMPAVELI in post-transplant patients with recurrent C3G or primary IC-MPGN.

⚠️ Felzartamab has not yet been approved by any regulatory authority, and its safety and effectiveness have not been established.

🩸 Antibody-mediated rejection (AMR) is a major cause of kidney transplant failure, often resulting from the immune system recognizing the donor kidney as foreign.

📉 Approximately 50% of people living with C3G or primary IC-MPGN suffer from kidney failure within five to 10 years of diagnosis.

💊 EMPAVELI is the first treatment approved in the United States for C3 glomerulopathy or primary immune complex membranoproliferative glomerulonephritis in patients 12 years and older.

⚠️ EMPAVELI carries a Boxed Warning for serious infections caused by encapsulated bacteria, such as Streptococcus pneumoniae and Neisseria meningitidis.

🛡️ EMPAVELI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the EMPAVELI REMS.

💉 Infusion-related reactions, including systemic hypersensitivity reactions and anaphylaxis, have occurred in patients treated with EMPAVELI.

👶 Females of reproductive potential are advised to use effective contraception during treatment with EMPAVELI and for 40 days after the last dose due to embryo-fetal harm risks.

🏢 Apellis and Sobi have global co-development rights for systemic pegcetacoplan, with Sobi holding exclusive ex-U.S. commercialization rights.

Bullish Signals
  • Biogen has secured acceptance for fourteen abstracts highlighting data from its nephrology portfolio at two major medical congresses: the 63rd European Renal Association Congress (ERA) and the 2026 American Transplant Congress (ATC).
  • The company's newly broadened nephrology portfolio now includes EMPAVELI® (pegcetacoplan) alongside multiple Phase 3 studies of investigational felzartamab, demonstrating strong pipeline momentum.
  • New post-hoc analyses from the pivotal Phase 3 VALIANT study for EMPAVELI will be presented, showcasing sustained efficacy and safety over one year in patients with C3 glomerulopathy or primary immune-complex membranoproliferative glomerulonephritis.
  • At the American Transplant Congress, additional analyses of the Phase 2 felzartamab trial will assess the investigational treatment's impact on patients with long-standing rejection history and various forms of previous rejection treatment.
  • Felzartamab is a potential first-in-class therapeutic candidate that Biogen owns exclusive worldwide rights to, offering promise as a pipeline-in-a-product across a range of immune-mediated diseases.
  • EMPAVELI is the first treatment approved in the United States for C3 glomerulopathy or primary immune complex membranoproliferative glomerulonephritis in patients 12 years and older to reduce proteinuria.
  • The collaboration with Sobi, which retains commercial rights to EMPAVELI outside the U.S., strengthens Biogen's global commercial strategy for its nephrology assets.
Risk Factors
  • EMPAVELI carries a Boxed Warning for serious infections caused by encapsulated bacteria (e.g., Streptococcus pneumoniae, Neisseria meningitidis), which can be life-threatening or fatal and requires mandatory vaccination and REMS program enrollment.
  • The drug is available only through a restricted Risk Evaluation and Mitigation Strategy (REMS) program, limiting market access and requiring prescribers to enroll and counsel patients on specific safety protocols.
  • Felzartamab remains unapproved by any regulatory authority as of the announcement date, meaning its safety and effectiveness have not been established for commercial sale.
  • The press release explicitly states that felzartamab is an investigational candidate with results from early-stage clinical trials that may not be predictive of later stage or large scale trial results.
  • Biogen's forward-looking statements regarding the potential benefits, safety, and efficacy of EMPAVELI and felzartamab are subject to substantial risks and uncertainties that could cause actual results to differ materially from expectations.
Full Analysis
Biogen Inc. (Nasdaq: BIIB) announced on June 3, 2026, that fourteen abstracts highlighting data from its nephrology portfolio have been accepted for presentation at the 63rd European Renal Association Congress (ERA) in Glasgow and the 2026 American Transplant Congress (ATC) in Boston. The presentations focus on two key assets: EMPAVELI® (pegcetacoplan), a complement inhibitor approved in the U.S. for C3 glomerulopathy (C3G) and primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN), and investigational felzartamab, an anti-CD38 monoclonal antibody being studied for antibody-mediated rejection (AMR) in kidney transplants. At the ERA congress, Biogen will present new post-hoc analyses from the pivotal Phase 3 VALIANT study and long-term extension data from the VALE study, demonstrating sustained efficacy and safety of EMPAVELI over one year in patients with C3G or IC-MPGN. These presentations are being made in collaboration with Sobi, which retains commercial rights to EMPAVELI outside the U.S. At the ATC, Biogen will share additional analyses of the Phase 2 felzartamab trial assessing its impact on patients with long-standing rejection history and different forms of previous treatment, alongside a sponsored symposium on emerging biomarkers for early identification of transplant rejection. The company highlighted that EMPAVELI is the first treatment approved in the U.S. to reduce proteinuria in patients 12 years and older with C3G or IC-MPGN, addressing rare diseases where approximately 50% of patients suffer kidney failure within five to 10 years of diagnosis. Felzartamab, originally developed by MorphoSys AG (now a Novartis company), is an investigational candidate that selectively depletes CD38+ plasma cells and has been shown in clinical studies to have promise across a range of immune-mediated diseases. Biogen owns exclusive worldwide rights to felzartamab, which remains unapproved by any regulatory authority as of the announcement date. The press release includes standard safety information for EMPAVELI, noting its availability only through a restricted REMS program due to risks of serious infections caused by encapsulated bacteria, and outlines adverse reactions such as infusion-site reactions and pyrexia. Biogen’s Chief Medical Officer, Daniel Quirk, stated that the presence at these two key medical congresses highlights the momentum of their newly broadened nephrology portfolio, with goals to advance science across a spectrum of kidney diseases and bring meaningful progress to patients.