Data presentations across multiple kidney diseases illustrate the breadth of Biogen’s nephrology portfolio with EMPAVELI® (pegcetacoplan) and felzartamab, an investigational anti-CD38 monoclonal antibody.
CAMBRIDGE, Mass., June 03, 2026 (GLOBE NEWSWIRE) --
Biogen Inc.
(Nasdaq: BIIB) announced that fourteen abstracts highlighting data from its nephrology portfolio, including EMPAVELI® (pegcetacoplan) and investigational felzartamab, have been accepted for presentation at the 63rd European Renal Association Congress (ERA) and the 2026 American Transplant Congress (ATC).
“Our presence across two key medical congresses highlights the momentum of our newly broadened nephrology portfolio, which now includes EMPAVELI® (pegcetacoplan) in addition to the multiple Phase 3 studies of felzartamab,” said Daniel Quirk, MD, Chief Medical Officer at Biogen. “We look forward to continuing to advance the science and development across a spectrum of kidney diseases, with the goal of helping to bring meaningful progress to patients.”
At ERA, taking place June 3-6 in Glasgow, Scotland, presentations include new post-hoc analyses from the pivotal Phase 3 VALIANT study for EMPAVELI and its long-term extension VALE study showing the sustained efficacy and safety pro EMPAVELI over one year in patients with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN). Presentations of EMPAVELI will be made in collaboration with Sobi, which retains commercial rights to EMPAVELI
®
(Aspaveli
®
in the EU) outside the U.S.
At ATC, taking place June 20-24 in Boston, Massachusetts, additional analyses of the Phase 2 felzartamab trial in antibody-mediated rejection (AMR) assess the impact of the investigational treatment on patients with long-standing rejection history and different forms of previous rejection treatment. A sponsored Symposium will educate on emerging biomarkers for early identification and monitoring of transplant rejection and illustrate the role of CD38+ cells in AMR and microvascular inflammation (MVI). Additionally, a presentation on EMPAVELI will share pooled data from two studies assessing treatment in post transplant patients with recurrent C3G or primary IC-MPGN.
European Renal Association Congress presentations include:
Oral Presentation:
“Pegcetacoplan treatment response in VALIANT/VALE: Impact of disease chronicity in C3G and primary IC-MPGN,” on Thursday, June 4
th
at 9:21 a.m. BST
Oral Presentation:
“Pegcetacoplan sustained clinical benefit in C3G and primary IC-MPGN through 1 year of therapy: Data from VALIANT/VALE,” on Thursday, June 4
th
at 11:27 a.m. BST
Oral Presentation:
“Pegcetacoplan treatment response in VALIANT/VALE: Impact of genetic and acquired complement dysregulation and disease type in C3G and primary IC-MPGN,” on Thursday, June 4
th
at 12:09 p.m. BST
Oral Presentation:
“Real-world clinical profile, treatment patterns and outcomes associated with C3G and primary IC-MPGN: insights from the UK RaDaR registry,” on Thursday, June 4
th
at 12:21 p.m. BST
Oral Presentation:
“Investigating the Effects of Felzartamab Treatment on Peripheral Blood Transcriptomes in Patients with Chronic Antibody-mediated Rejection,” on Thursday, June 4
th
at 12:33 p.m. BST
Oral Presentation:
“Safety and low incidence of meningococcal infections with pegcetacoplan in C3G / primary IC-MPGN and PNH,” on Thursday, June 4
th
at 3:27 p.m. BST
Oral Presentation:
“Evaluation of pegcetacoplan in adults and adolescents with focal segmental glomerulosclerosis: Rationale and design of a sequential phase 2/3 study,” on Thursday, June 4
th
at 4:24 p.m. BST
Oral Presentation:
“Decreasing rates of injection site reactions over time: Long-term outcomes across multiple indications support pegcetacoplan for C3G/primary IC-MPGN,” on Friday, June 5
th
at 9:03 a.m. BST
Oral Presentation:
“Prolonged CD38 Targeting with Felzartamab Achieves Sustained Suppression of Antibody-mediated Rejection: Biomarker-guided Open-label Phase 2 Extension,” on Friday, June 5
th
at 9:27 a.m. BST
Oral Presentation:
“Soluble BCMA as a Biomarker of CD38+ Plasma Cell Depletion in Felzartamab-Treated Patients With IgA Nephropathy From the Phase 2 IGNAZ Study,” on Friday, June 5
th
at 4:24 p.m. BST
Poster Presentations:
Pegcetacoplan population pharmacokinetics and exposure-response analysis in adolescent and adult patients with C3G or primary IC-MPGN on Friday, June 5
th
at 6:15 p.m. BST
Epidemiology of C3G and primary IC-MPGN: a systematic literature review and meta-analysis on Friday, June 5
th
at 6:15 p.m. BST
American Transplant Congress presentations include:
Symposium:
“Advancements in Antibody-Mediated Rejection and Microvascular Inflammation of Kidney Allograft: Biology, Biomarkers, and Beyond,” on Tuesday, June 23
rd
from 12:15 p.m. – 1:15 p.m. EDT
Oral Presentation:
“Felzartamab, an anti-CD38 antibody, in late AMR: efficacy independent of prior rejection history or therapy “on Monday, June 22
nd
at 11:15 a.m. EDT
Oral Presentation:
“Effects of felzartamab on Digital Cytometry Leukocyte Estimates in Biopsies with ABMR,” on Sunday, June 21
st
at 3:45 p.m. EDT
Oral Presentation:
“Pegcetacoplan for Posttransplant Patients with Complement 3 Glomerulopathy or Primary (Idiopathic) Immune-Complex membranoproliferative Glomerulonephritis,” on Sunday, June 21
st
at 3:45 p.m. EDT
Poster Presentations:
Late breaking poster
:
“Felzartamab for antibody mediated rejection: a phase 2 open label extension study,” on Saturday, June 20
th
at 5:45 p.m. EDT
“Establishing a central pathology review process and adjudication framework to standardize biopsy-based endpoints in transplant clinical trials” on Saturday, June 20
th
at 5:45 p.m. EDT
“TRANSCEND and TRANSPIRE: phase 3 and 2 trials of the anti-CD38 antibody felzartamab in kidney transplant recipients with antibody medical rejection or isolated microvascular inflammation,” on Monday, June 22
nd
at 2:45 p.m. EDT
“Monitoring anti-CD38 treatment with felzartamab in antibody mediated kidney allograft rejection,” on Monday, June 22
nd
at 2:45 p.m. EDT
“Effect of the anti-CD38 antibody felzartamab on Natural Killer cells” on Monday, June 22
nd
at 2:45 p.m. EDT
About Felzartamab
Felzartamab is an investigational therapeutic human monoclonal antibody directed against CD38, a protein expressed on plasma cells, plasmablasts, and natural killer, or NK, cells. Felzartamab is a potential first-in-class therapeutic candidate with promise as a pipeline-in-a-product across a range of immune-mediated diseases. Felzartamab has been shown in clinical studies to selectively deplete CD38+ plasma cells, which may allow applications that ultimately improve clinical outcomes in a broad range of diseases driven by pathogenic antibodies. Felzartamab was originally developed by MorphoSys AG (now MorphoSys GmbH, a Novartis company). Biogen owns exclusive worldwide rights to felzartamab.
Felzartamab is an investigational therapeutic candidate that has not yet been approved by any regulatory authority and its safety and effectiveness have not been established.
About Antibody-Mediated Rejection (AMR) in Kidney Transplant Recipients
Antibody-mediated rejection (AMR) is a major cause of kidney transplant failure. AMR in kidney transplant is caused by the immune system recognizing the donor kidney as foreign. This can result in antibodies being generated against the donor kidney and potentially leading to its destruction and eventual rejection. AMR demonstrates different properties depending on whether it occurs early (6 months) post-transplantation. Late AMR is associated with a greater risk of graft loss versus early.
1
Effective treatment options for late AMR are currently limited.
2
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.
3-5
Additionally, approximately 90% of patients who previously received a kidney transplant will experience disease recurrence.
6
About the VALIANT Study
The VALIANT Phase 3 study (
NCT05067127
) was a randomized, placebo-controlled, double-blinded, multi-center study that evaluated EMPAVELI® (pegcetacoplan) efficacy and safety 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 pediatric and adult patients, with native and post-transplant kidneys. Study participants were randomized to receive EMPAVELI or placebo twice weekly for 26 weeks. Following this 26-week randomized controlled period, patients were able to proceed to a 26-week open-label phase in which all patients received 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 Empaveli (pegcetacoplan)
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. Empaveli is also approved for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) in the United States, European Union, and other countries globally, and is under investigation for other rare diseases.
U.S. Important Safety Information for EMPAVELI
BOXED WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA
EMPAVELI, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as
Streptococcus pneumoniae, Neisseria meningitidis
,
and
Haemophilus influenzae
type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.
Complete or update vaccination for encapsulated bacteria at least 2 weeks prior to the first dose of EMPAVELI, unless the risks of delaying therapy with EMPAVELI outweigh the risks of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against encapsulated bacteria in patients receiving a complement inhibitor.
Patients receiving EMPAVELI are at increased risk for invasive disease caused by encapsulated bacteria, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious infections and evaluate immediately if infection is suspected.
Because of the risk of serious infections caused by encapsulated bacteria, EMPAVELI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the EMPAVELI REMS.
CONTRAINDICATIONS
Hypersensitivity to pegcetacoplan or to any of the excipients
For initiation in patients with unresolved serious infection caused by encapsulated bacteria including
Streptococcus pneumoniae
,
Neisseria meningitidis
, and
Haemophilus influenzae
type B
WARNINGS AND PRECAUTIONS
Serious Infections Caused by Encapsulated Bacteria
EMPAVELI, a complement inhibitor, increases a patient’s susceptibility to serious, life-threatening, or fatal infections caused by encapsulated bacteria including
Streptococcus pneumoniae
,
Neisseria meningitidis
(caused by any serogroup, including non-groupable strains), and
Haemophilus influenzae
type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors. The initiation of EMPAVELI treatment is contraindicated in patients with unresolved serious infection caused by encapsulated bacteria.
Complete or update vaccination against encapsulated bacteria at least 2 weeks prior to administration of the first dose of EMPAVELI, according to the most current ACIP recommendations for patients receiving a complement inhibitor. Revaccinate patients in accordance with ACIP recommendations considering the duration of therapy with EMPAVELI. Note that ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information. If urgent EMPAVELI therapy is indicated in a patient who is not up to date with vaccines against encapsulated bacteria according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible. The benefits and risks of treatment with EMPAVELI, as well as the benefits and risks of antibacterial drug prophylaxis in unvaccinated or vaccinated patients, must be considered against the known risks for serious infections caused by encapsulated bacteria.
Vaccination does not eliminate the risk of serious encapsulated bacterial infections, despite development of antibodies following vaccination. Closely monitor patients for early signs and symptoms of serious infection and evaluate patients immediately if an infection is suspected. Inform patients of these signs and symptoms and instruct patients to seek immediate medical care if these signs and symptoms occur. Promptly treat known infections. Serious infection may become rapidly life-threatening or fatal if not recognized and treated early. Consider interruption of EMPAVELI in patients who are undergoing treatment for serious infections.
EMPAVELI is available only through a restricted program under a REMS.
EMPAVELI REMS
EMPAVELI is available only through a restricted program under a REMS called EMPAVELI REMS, because of the risk of serious infections caused by encapsulated bacteria. Notable requirements of the EMPAVELI REMS include the following:
Under the EMPAVELI REMS, prescribers must enroll in the program. Prescribers must counsel patients about the risks, signs, and symptoms of serious infections caused by encapsulated bacteria, provide patients with the REMS educational materials, ensure patients are vaccinated against encapsulated bacteria at least 2 weeks prior to the first dose of EMPAVELI, prescribe antibacterial drug prophylaxis if patients’ vaccine status is not up to date and treatment must be started urgently, and provide instructions to always carry the Patient Safety Card both during treatment, as well as for 2 months following last dose of EMPAVELI. Pharmacies that dispense EMPAVELI must be certified in the EMPAVELI REMS and must verify prescribers are certified.
Further information is available at
or 1-888-343-7073.
Infusion-Related Reactions
Systemic hypersensitivity reactions (eg, facial swelling, rash, urticaria, pyrexia) have occurred in patients treated with EMPAVELI, which may resolve after treatment with antihistamines. Cases of anaphylaxis leading to treatment discontinuation have been reported. If a severe hypersensitivity reaction (including anaphylaxis) occurs, discontinue EMPAVELI infusion immediately, institute appropriate treatment, per standard of care, and monitor until signs and symptoms are resolved.
Interference with Laboratory Tests
There may be interference between silica reagents in coagulation panels and EMPAVELI that results in artificially prolonged activated partial thromboplastin time (aPTT); therefore, avoid the use of silica reagents in coagulation panels.
ADVERSE REACTIONS
Most common adverse reactions in adult and pediatric patients 12 years of age and older with C3G or primary IC-MPGN (incidence ≥10%) were infusion-site reactions, pyrexia, nasopharyngitis, influenza, cough, and nausea.
USE IN SPECIFIC POPULATIONS
Females of Reproductive Potential
EMPAVELI may cause embryo-fetal harm when administered to pregnant women. Pregnancy testing is recommended for females of reproductive potential prior to treatment with EMPAVELI. Advise female patients of reproductive potential to use effective contraception during treatment with EMPAVELI and for 40 days after the last dose.
Please see full
Prescribing Information
, including Boxed WARNING regarding serious infections caused by encapsulated bacteria, and
Medication Guide
.
About the Sobi® and Apellis (now part of Biogen) Collaboration
Apellis and Sobi have global co-development rights for systemic pegcetacoplan. Sobi has exclusive ex-U.S. commercialization rights for systemic pegcetacoplan. Apellis has exclusive U.S. commercialization rights for systemic pegcetacoplan and worldwide commercial rights for ophthalmological pegcetacoplan, including for geographic atrophy.
About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.
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Biogen Safe Harbor
This news release contains forward-looking statements, relating to, among others: the potential benefits, safety and efficacy of EMPAVELI and felzartamab; the potential of felzartamab to be an important option in addressing the effects of AMR and MVI; the potential of Biogen's commercial business and pipeline programs, including EMPAVELI and felzartamab; potential regulatory discussions, submissions and approvals and the timing thereof; and the risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance,” “hope,” “intend,” “may,” “objective,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would” or the negative of these words or other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.
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References:
Fernando et al. (2023) Early Versus Late Acute AMR in Kidney Transplant Recipients – A Comparison of Treatment Approaches and Outcomes From the ANZDATA Registry. Available at:
Schinstock et al. (2018) Kidney Transplant with Low Levels of DSA or Low Positive B-Flow Crossmatch: An Underappreciated Option for Highly-Sensitized Transplant Candidates (Page 8). Available at: Ciancio et al. 2018 Antibody-Mediated Rejection Implies a Poor Prognosis in Kidney Transplantation: Results From a Single Center. Available at:
Smith RJH, et al. Nat Rev Nephrol. 2019;15(3):129-143.
Servais A, et al. Kidney Int. 2012;82(4):454-464.
Zand L, et al. J Am Soc Nephrol. 2014;25(5):1110-1117.
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.
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