Patrick Campbell is the editorial director of HCPLive. Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter and/or multimedia specialist with the Pocono Record, Star News Group, and NJ Advance Media. He is the executive producer for multiple HCPLive podcasts, including Diabetes Dialogue, Don't Miss a Beat, Kidney Compass, Medical Ethics Unpacked, The Medical Sisterhood, and Skin of Color Savvy. 


Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

At a moment when nephrology is experiencing one of its most rapid periods of therapeutic evolution, 

American Society of Nephrology (ASN) Kidney Week 2025 

arrived in Houston, Texas as both an opportunity for reflection of extraordinary progress and a preview of what may soon redefine care further. The past year alone has seen long-awaited FDA approvals in 

, alongside expanding evidence for upstream immune-targeted strategies that are reshaping expectations for disease modification. With an anticipated regulatory decision in FSGS on the horizon in early 2026, the field is entering a new era marked by unprecedented mechanistic diversity and clinical ambition.

This year’s meeting spotlighted this momentum, highlighting advances across glomerular disease, transplant immunology, inherited kidney disorders, and cardiorenal medicine. From deeper biologic insights to maturing late-stage pipelines, Kidney Week 2025 showcased a discipline moving beyond supportive care frameworks and toward targeted interventions capable of altering long-term kidney trajectories. In this recap, we highlight 8 trial updates to know from the meeting.

Kidney Week 2025 Recap: 8 Trial Updates to Know in Nephrology

ORIGIN 3 Sets the Stage for Atacicept in IgA Nephropathy

Interim 36-week data from the phase 3 ORIGIN 3 trial show atacicept, a dual BAFF/APRIL inhibitor, reduced UPCR by 45.7% from baseline, yielding a 41.8-point placebo-adjusted advantage in adults with IgAN.

Secondary outcomes demonstrated strong biologic and clinical effects, including a 68.3% drop in Gd-IgA1, 81.0% hematuria resolution, and a 47.3% reduction in UACR by week 36. Safety data revealed greater rates of injection-site reactions but fewer serious adverse events than placebo (0.5% vs 5.1%) and no deaths.

Kidney Compass: Atacicept and ORIGIN 3 at Kidney Week 2025, with Richard Lafayette, MD

Kidney Compass Clip of Richard Lafayette, MD, discussing Atacicept Results at Kidney Week 2025

Kidney Compass: Atacicept Results Clip

FINE-ONE: Finerenone Proves Benefit in Type 1 Diabetes and CKD

Finerenone produced a 25% relative reduction in UACR over 6 months versus placebo in adults with type 1 diabetes and chronic kidney disease, meeting the primary endpoint of the FINE-ONE trial (LSGM ratio 0.75; 95% CI, 0.65 to 0.87; 

Of note, 68.1% of finerenone-treated patients achieved a ≥30% UACR reduction compared with 46.6% on placebo, aligning with ADA thresholds linked to slower kidney disease progression. The safety profile, including hyperkalemia incidence, was consistent with prior finerenone programs, with no new safety signals identified across 242 participants.

Diabetes Dialogue: FINE-ONE and Finerenone in Type 1 Diabetes at Kidney Week 2025

Diabetes Dialogue FINE-ONE Recap Clip

PISCES: Fish Oil Slashes Cardiovascular Event Risk in Maintenance Dialysis

In the phase 3 PISCES trial, 4 grams of n−3 polyunsaturated fatty acids (n-3 PUFA) (1.6 grams EPA, 0.8 grams DHA) daily in adults on maintenance hemodialysis reduced the rate of serious cardiovascular events to 0.31 vs 0.61 per 1000 patient-days compared with placebo (Hazard Ratio [HR], 0.57, 95% CI 0.47–0.70; P < .001). Benefits were consistent across cardiac death (HR, 0.55), MI (HR, 0.56), stroke (HR, 0.37), peripheral vascular disease requiring amputation (HR, 0.57), and first CV event or all-cause death (HR, 0.73), with similar adverse-event rates between groups. Effects were observed in both patients with and without prior cardiovascular events, and no major safety signals emerged in the 1228-person cohort.

Setanaxib Clears Hurdle in Phase 2 Alport Syndrome Trial

In this 24-week phase 2a trial of 20 patients with genetically confirmed Alport syndrome, setanaxib was safe and well tolerated, with adverse-event rates similar to placebo and a single unrelated serious adverse event. Setanaxib produced a 15% mean reduction in UPCR versus placebo, with 15.4% of patients achieving ≥25% reduction and 38.5% achieving ≥10% reduction despite already optimized RAASi and SGLT2 inhibitor therapy. Notably, a 27% mean UPCR reduction persisted 4 weeks after treatment discontinuation, suggesting sustained pharmacodynamic activity.

Kidney Compass: Setanaxib, Alport Syndrome, and RaDaR Updates at Kidney Week 2025

Kidney Compass clip of Prof. Danny Gale discussing phase 2 data on setanaxib in Alport Syndrome

Kidney Compass Phase 2 Alport Syndrome Clip

MIL62 Increased Remission and Reduced Relapse in Membranous Nephropathy

MIL62, a glycoengineered type II anti-CD20 antibody, achieved greater complete remission rates than cyclosporine A in a 153-patient, 2-year randomized phase 3 trial of biopsy-proven primary membranous nephropathy (MN), with 49.4% vs 3.9% remission at week 76 (

 < .0001). MIL62 also produced faster and deeper disease control, including 87.5% vs 10.5% immunologic remission and a median time to complete remission of 14.1 months, which was never reached in the cyclosporine arm.

Risks of treatment failure and relapse were significantly reduced (HR, 0.04 and 0.07, respectively), alongside improvements in eGFR and quality-of-life measures. Safety was comparable between groups with no new signals, supporting MIL62 as a strong therapeutic option for primary MN.

Povetacicept Data Validate APRIL/BAFF Inhibition in IgAN and pMN

In the phase 1/2 RUBY-3 trial, povetacicept, a dual BAFF/APRIL inhibitor, produced substantial 48-week proteinuria reductions in both IgAN and primary MN, including a 64% mean UPCR reduction in IgAN (with 65% achieving <0.5 g/g and 77% declines in Gd-IgA1) and an 82% UPCR reduction with 100% immunologic remission in pMN.

Hematuria resolved in 90% of IgAN patients, over half achieved clinical remission, and kidney function remained stable across cohorts. Reductions in pathogenic biomarkers (Gd-IgA1 and anti-PLA2R) were early, deep, and sustained, supporting a potential disease-modifying effect through upstream interruption of B-cell biology. Safety data suggested povetacicept was generally well tolerated, with monitored IgG reductions but no serious infections or evidence of clinically meaningful immunosuppression.

BESTOW: Tegoprubart Showcases Safer Prevention of Kidney Transplant Rejection Over Tacrolimus

In the phase 2 BESTOW trial of 126 kidney transplant recipients, tegoprubart achieved eGFR comparable to tacrolimus at 12 months (69 vs 66 mL/min/1.73 m²), with several subgroups, including living-related and high-KDPI donor recipients, showing numerically greater eGFR on tegoprubart.

The composite efficacy failure rate (death, graft loss, BPAR) was 22% with tegoprubart vs 17% with tacrolimus, supporting noninferiority. Tegoprubart demonstrated a more favorable safety profile, with markedly lower rates of new-onset diabetes (1 in 47 vs 1 in 6), tremor (1.6% vs 25%), delayed graft function (14.3% vs 25.0%), and fewer severe infections such as sepsis/bacteremia (4.8% vs 17.2%).

Innovation in Transplant Immunosuppression With Tegoprubart, With John Gill, MD

John Gill, MD, discusses tegoprubart results in kidney transplantation from Kidney Week 2025

John Gill, MD, on tegoprubart results in kidney transplantation

Telitacicept Achieves Primary Endpoint in IgA Nephropathy Phase 3 Study

In a 39-week randomized, double-blind trial, telitacicept, a BLyS/APRIL-targeting fusion protein, reduced 24-hour UPCR by 58.9% versus 8.8% with placebo (

 <.0001), with sustained 55% reductions at week 39. Clinically meaningful proteinuria thresholds were achieved far more frequently with telitacicept, including UPCR <0.8 g/g in 61% vs 19.5%, <0.5 g/g in 42.1% vs 7.5%, and <0.3 g/g in 24.5% vs 0.6% of patients. Kidney function remained stable, with mean eGFR essentially unchanged (−0.010 vs −0.77 mL/min/1.73 m²) and a lower risk of ≥30% eGFR decline in the telitacicept arm.

Kidney Compass: Phase 3 Data on Telitacicept in IgA Nephropathy at ASN Kidney Week 2025

Kidney Compass clip discussing Telitacicept eGFR Data at Kidney Week 2025

Kidney Compass: Telitacicept eGFR Data at Kidney Week 2025

Novartis. Novartis receives FDA accelerated approval for Vanrafia® (atrasentan), the first and only selective endothelin A receptor antagonist for proteinuria reduction in primary IgA nephropathy (IgAN). Novartis United States of America. Published April 2, 2025. Accessed November 22, 2025. 

https://www.novartis.com/us-en/news/media-releases/novartis-receives-fda-accelerated-approval-vanrafia-atrasentan-first-and-only-selective-endothelin-receptor-antagonist-proteinuria-reduction-primary-iga-nephropathy-igan

Novartis. Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G). Novartis. Published March 21, 2025. Accessed November 22, 2025. 

https://www.novartis.com/news/media-releases/novartis-receives-third-fda-approval-oral-fabhalta-iptacopan-first-and-only-treatment-approved-c3-glomerulopathy-c3g

Apellis Pharmaceuticals. FDA Approves Apellis’ EMPAVELI® (pegcetacoplan) as the First C3G and Primary IC-MPGN Treatment for Patients 12 and Older | Apellis Pharmaceuticals, Inc. Apellis Pharmaceuticals, Inc. Published July 28, 2025. Accessed November 22, 2025. 

https://investors.apellis.com/news-releases/news-release-details/fda-approves-apellis-empavelir-pegcetacoplan-first-c3g-and

Vera Therapeutics. Vera Therapeutics Announces Positive ORIGIN Phase 3 Data for Atacicept in IgA Nephropathy Presented at ASN Kidney Week 2025 and Published in the New England Journal of Medicine | Vera Therapeutics. Vera Therapeutics. Published November 6, 2025. Accessed November 22, 2025. 

https://ir.veratx.com/news-releases/news-release-details/vera-therapeutics-announces-positive-origin-phase-3-data

Bayer. Finerenone showed statistically significant reduction of UACR in adults with chronic kidney disease associated with type 1 diabetes. Finerenone showed statistically significant reduction of UACR in adults with chronic kidney disease associated with type 1 diabetes. Published November 6, 2025. Accessed November 22, 2025. 

https://www.bayer.com/media/en-us/finerenone-showed-statistically-significant-reduction-of-uacr-in-adults-with-chronic-kidney-disease-associated-with-type-1-diabetes/

Lok CE, Farkouh M, Hemmelgarn BR, et al. Fish-Oil Supplementation and Cardiovascular Events in Patients Receiving Hemodialysis. 

. Published online November 7, 2025. doi:

Safety and Preliminary Efficacy Findings from a Phase 2A Randomized, Double- Blind, Placebo-Controlled Trial of Setanaxib in Patients with Alport Syndrome. 

Presented at the American Society of Nephrology (ASN) Kidney Week. Houston, Texas. November 05-09, 2025.

Cui Z, Wei M, Li P, et al. Efficacy and Safety of MIL62, a Glycoengineered Type II Anti-CD20 Antibody, in Primary Membranous Nephropathy: A Phase 3, Randomized, Controlled Trial. October 2025 - Volume 36 - Issue 10S: Journal of the American Society of Nephrology. Published online October 2025. Accessed November 18, 2025. 

https://journals.lww.com/jasn/fulltext/2025/10001/efficacy_and_safety_of_mil62

Efficacy and Safety of Povetacicept in Patients with IgAN and Primary Membranous Nephropathy (pMN) at 48 Weeks of Treatment: The RUBY-3 Study

. the American Society of Nephrology (ASN) Kidney Week. Houston, Texas. November 05-09, 2025.

Eledon Pharmaceuticals. Eledon Presents Phase 2 BESTOW Trial Results for Tegoprubart for the Prevention of Rejection in Kidney Transplantation at the American Society of Nephrology’s Kidney Week 2025 Annual Meeting | Eledon Pharmaceuticals, Inc. Eledon Pharmaceuticals, Inc. Published November 6, 2025. Accessed November 22, 2025. 

https://ir.eledon.com/news-releases/news-release-details/eledon-presents-phase-2-bestow-trial-results-tegoprubart

Vor Bio. Telitacicept Achieved Primary Endpoint of Reducing Proteinuria in Stage A of a Phase 3 Clinical Study for IgA Nephropathy in China | Vor Bio. Vor Bio. Published November 8, 2025. Accessed November 22, 2025. 

https://ir.vorbio.com/news-releases/news-release-details/telitacicept-achieved-primary-endpoint-reducing-proteinuria

Articles

Nephrology is undergoing a transformative period with significant therapeutic advancements, as highlighted at the ASN Kidney Week 2025 in Houston. Recent FDA approvals in IgA nephropathy and C3 glomerulopathy, along with emerging immune-targeted strategies, are reshaping disease management. The meeting showcased progress in glomerular disease, transplant immunology, inherited kidney disorders, and cardiorenal medicine, emphasizing a shift from supportive care to targeted interventions. Key trial updates included promising results for atacicept, finerenone, fish oil, setanaxib, MIL62, povetacicept, tegoprubart, and telitacicept, indicating a new era of mechanistic diversity and clinical ambition.

A curated recap of 8 impactful trial updates from the American Society of Nephrology Kidney Week 2025.

News

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IgA Nephropathy

The HCPLive Berger disease page is a resource for medical news and expert insights on IgA nephropathy. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in Berger disease, and more.

C3 Glomerulopathy

The HCPLive C3 glomerulopathy page is a resource for medical news and expert insights on C3G. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in C3G, and more.

Focal Segmental Glomerulosclerosis

The HCPLive focal segmental glomerulosclerosis page is a resource for medical news and expert insights on FSGS. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in FSGS, and more. 

Chronic Kidney Disease

Nephrology

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 conference coverage page features articles, videos, and expert-led live coverage from major medical meetings throughout the year.

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include the US Food and Drug Administration acceptance of a supplemental New Drug Application (sNDA) for roflumilast (Zoryve) cream 0.3% in children aged 2-5 years with 

 and the approval of plozasiran (Redemplo) for the reduction of triglycerides in adult patients with familial chylomicronemia syndrome (FCS), new American Gastroenterological Association (AGA) clinical practice guidelines on the pharmacologic management of moderate-to-severely active Crohn’s disease (CD), and phase 3 data on telitacicept in IgA nephropathy and tralokinumab in adults with 

 and moderate-to-severe hand involvement.

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of November 16, 2025—let’s jump in!

FDA Accepts sNDA for Roflumilast Cream 0.3% in Children Ages 2 to 5 with Psoriasis

On November 17, 2025, the FDA accepted Arcutis Biotherapeutics’ sNDA for roflumilast (Zoryve) cream 0.3% in children 2-5 years of age with psoriasis, assigning a PDUFA target action date of June 29, 2026. The sNDA is supported by data from a 4-week Maximal Usage Systemic Exposure (MUSE) study in children aged 2-5 years with plaque psoriasis, as well as data from a long-term open-label study that included children in that age range.

FDA Approves Plozasiran for Adults With Familial Chylomicronemia Syndrome

On November 18, 2025, the FDA approved Arrowhead Pharmaceuticals’ plozasiran (Redemplo) for the reduction of triglycerides in adult patients with FCS, making it the first and only FDA-approved siRNA medicine for people living with FCS. The decision was supported by clinical data from the phase 3 PALISADE study.

AGA Releases Updated Clinical Crohn’s Disease Guideline Reflecting New Therapies

On November 20, 2025, the AGA released a living clinical practice guideline on the pharmacologic management of moderate-to-severely active CD, intended to support a comprehensive, patient-centered, evidence-based approach to managing this patient population. The document includes 16 recommendations emphasizing early use of high-efficacy therapies including infliximab, adalimumab, ustekinumab, risankizumab, mirikizumab, guselkumab, and upadacitinib over step-up treatment to improve patient outcomes.

New phase 3 data show that in patients with IgAN at high risk of progression, treatment with telitacicept for 39 weeks resulted in a rapid, substantial, and statistically significant reduction in proteinuria compared with placebo, with a favorable safety profile. The investigational recombinant fusion protein enters a rapidly evolving therapeutic landscape in IgAN, where multiple B-cell–, BAFF-, and APRIL-targeted approaches are under active clinical investigation.

Tralokinumab Improves Atopic Dermatitis with Hand Involvement at 32 Weeks

On November 17, 2025, LEO Pharma A/S announced positive topline key findings on tralokinumab in adults with atopic dermatitis and moderate-to-severe hand involvement who are also candidates for systemic treatments. Findings from the 32-week analysis of the phase 3b ADHAND trial evaluating patients with atopic dermatitis and disease involvement affecting the hands build upon previous week 16 findings demonstrating statistically significant improvement compared to placebo in all primary and key secondary endpoints such as clear or almost clear skin, itch, and pain.

The FDA has accepted a supplemental New Drug Application for roflumilast cream for young children with psoriasis, with a decision expected by June 2026. Plozasiran has been approved for reducing triglycerides in adults with familial chylomicronemia syndrome, marking it as the first siRNA treatment for this condition. The AGA has updated its guidelines for Crohn’s disease, recommending early use of high-efficacy therapies. Telitacicept has shown significant efficacy in reducing proteinuria in IgA nephropathy. Tralokinumab has demonstrated improvements in atopic dermatitis with hand involvement in a phase 3b trial.

Stay updated with the latest healthcare breakthroughs, including FDA approvals and new Crohn's disease guidelines, in this week's essential news roundup.

Gastroenterology

Gastroenterology condition center page is a comprehensive resource for clinical news and insights on digestive and GI conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for 

, IBS and IBD, Crohn's disease, and more.

Dermatology

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Allergy

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The HCPFive: Top News for Healthcare Providers from the Week of 11/16

Chelsie Derman is an associate editor for 

who covers psychiatry, sleep medicine, geriatrics, migraine, and allergy. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

New data presented as a late breaker at the 

2025 American College of Allergy, Asthma, & Immunology (ACAAI) Annual Scientific Meeting 

in Orlando, Florida, show that the Viaskin Peanut Patch builds 

 in more than 70% of toddlers within 3 years.

“These results show that ongoing treatment with the peanut patch continues to improve tolerance and remains safe over time,” said lead investigator Matthew Greenhawt, MD, MBA, from the Children’s Hospital Colorado, in a statement. “For parents of toddlers with peanut allergies, this kind of approach may one day offer peace of mind by reducing the risk of having an allergic reaction, including severe reactions, from accidental exposure.”

Back in April, the phase 3 EPITOPE trial published in the Annals of Allergy, Asthma, & Immunology reported that Viaskin Peanut Patch (VP250; 250 µg) was effective and safe in desensitizing peanut allergies in children aged 1 – 3 years by month 12, regardless of atopic comorbidities, such as asthma, atopic dermatitis, and concomitant food allergy.

 The Viaskin Peanut Patch, which is an epicutaneous immunotherapy, delivers small amounts of peanut protein through the skin. This new analysis, presented at the meeting, was the open-label extension of EPITOPE, examining 56 toddlers who initially received a placebo in an earlier 1-year study and then used the peanut patch for up to 3 years.

“These results are consistent with outcomes observed after 36 months in VP250-treated EPITOPE participants,” Greenhawt and colleagues wrote.

After 3 years of treatment, 71.2% of toddlers could tolerate the equivalent of 3 to 4 peanut kernels (≥1000 mg), compared to only 62.7% after 1 year of treatment. Nearly half of the toddlers could tolerate even greater amounts of peanut, tolerating ≥ 2000 mg at month 12 (36.5%) and 36 (46.0%). In total, 28.4% and 42% completed the double-blind, placebo-controlled food challenges at months 12 and 36 without meeting stopping criteria.

Not only was the peanut path effective, but it was also safe. The study had no reports of treatment-emergent anaphylaxis in the third year. The most common adverse event, which was skin irritation at the patch side, became less frequent over time.

During the 3 years, children’s reactions during food challenges turned milder. Children also had fewer severe symptoms after 3 years than after 1 year. In the study, 10% had severe symptoms during food challenges at month 36, compared with 19.2% at month 12.

These findings suggest that intervening early in young children may help alter the trajectory of peanut allergy. Investigators emphasized that parents should not attempt any form of peanut desensitization at home but rather discuss treatments with a board-certified allergist.

According to FARE, 1 in 13 children have food allergies, and among them, more than 40% have experienced a severe reaction.

 Although children with peanut allergy can turn to oral immunotherapy, it is linked to adverse events of nausea, vomiting, eosinophilic esophagitis, and anaphylaxis. Omalizumab, approved for food allergies in February 2024, has demonstrated effectiveness for this indication, but limited evidence exists on this drug’s sustained duration of effect. 

 The Viaskin Peanut Patch provides another potential desensitization option for young children with peanut allergy.

Peanut Patch Treatment Continues to Help Toddlers Safely Build Tolerance Over Three Years. Acaai.org. Published 2025. Accessed November 21, 2025. 

https://annualmeeting.acaai.org/2025/peanut-patch-treatment.cfm

Derman, C. Viaskin Patch Effective in Peanut-Allergic Kids with Atopic Comorbidities. HCPLive. 

https://www.hcplive.com/view/viaskin-patch-effective-in-peanut-allergic-kids-with-atopic-comorbidities

Food Allergy Research & Education. Facts and statistics. Food Allergy Research & Education. Published 2024. 

https://www.foodallergy.org/resources/facts-and-statistics

Smith T. FDA Approves Omalizumab as First Treatment of 1 or More Food Allergies for Children, Adults. HCPLive. February 16, 2024. 

https://www.hcplive.com/view/fda-approves-omalozumab-first-treatment-of-1-or-more-food-allergies-for-children-adults

The Viaskin Peanut Patch has shown promising results in building peanut tolerance in over 70% of toddlers within three years, according to new data from the ACAAI Annual Scientific Meeting. The patch, an epicutaneous immunotherapy, delivers small amounts of peanut protein through the skin and has proven effective and safe, with no treatment-emergent anaphylaxis reported in the third year. The study highlights the potential of early intervention in altering the trajectory of peanut allergies, though it emphasizes the importance of consulting a board-certified allergist for treatment.

New findings reveal the Viaskin Peanut Patch effectively builds peanut tolerance in over 70% of toddlers, offering hope for allergy management.

Over 70% of Toddlers Tolerate 3 to 4 Peanut Kernels 3 Years After Peanut Patch

Alex Hillenbrand is an assistant editor for 

. She earned her BA in English from Lafayette College in 2023 and went on to write for pop culture, entertainment, and sports media outlets before joining MJH Life Sciences in 2025. In her free time, Alex enjoys cooking, going on walks, and meeting new people. Contact her at mjhlifesciences.com.

New research shows MIL62 achieved significantly increased complete remission rates than cyclosporine A in adults with primary membranous nephropathy (MN).

The 2-year, multicenter, randomized, open-label phase 3 trial evaluated whether adults with biopsy-proven MN achieved complete remission, defined as a urine protein-creatinine ratio (UPCR) <0.3 g/g with <15% decline in estimated glomerular filtration rate (eGFR) compared to standard-of-care cyclosporine A.

Membranous nephropathy is characterized by nephrotic-range proteinuria (>3.5 g/day) caused by antibodies targeting native podocyte antigens, most commonly the phospholipase A2 receptor (PLA2R). Approximately 75%-80% of MN cases are primary autoimmune, while the remainder are secondary to other conditions.

Cyclosporine A, a calcineurin inhibitor, is a standard treatment option for moderate-to-high risk MN. Cyclosporine A suppresses T-cell activity and stabilizes podocytes, thereby helping to control nephrotic syndrome and reduce proteinuria. The therapy does not eliminate PLA2R antibodies or B cells, leaving the underlying autoimmune process unchanged. As a result, relapse often occurs when treatment stops.

MIL62 is a glycoengineered, type II anti-CD20 monoclonal antibody intended to enhance antibody-dependent cellular cytotoxicity and deepen B-cell depletion and directly address the autoimmune drivers of primary MN.

In the phase 3 trial, 153 adults with biopsy-proven MN were randomly assigned in a 1:1 ratio to 1000 mg intravenous MIL62 (n = 77) at week 1, 3, 25, 27, and 52, or 52-week trough 125-175 ng/mL cyclosporine A (n = 76), tapered for up to 8 weeks. The primary endpoint was complete remission at week 76. Secondary endpoints included overall remission, times to immunologic/clinical remission, relapse and treatment failure, renal function, quality of life, safety, and complete remission at week 52.

By week 76, complete remission occurred in 49.4% of patients receiving MIL62 compared with 3.9% receiving cyclosporine A, an absolute difference of 46.5% (95% confidence interval [CI], 32.1-60.9; P <.0001; RR, 12.5; 95% CI, 4.0-39.0). At week 52, complete remission rates continued to favor MIL62 over cyclosporine A (37.7% vs 6.6%; 

 <.0001). Overall remission rates were consistently higher with MIL62 at weeks 24, 52, and 76 (all 

MIL62 also accelerated disease control with a median time to complete remission of 14.1 months (95% CI, 10.4 to 17.7) with MIL62, whereas the median time was not reached in the cyclosporine A group (Hazard Ratio [HR], 4.3; 95% CI, 2.4 to 7.8; 

 <.0001). Immunologic remission occurred in 87.5% of patients treated with MIL62 compared with 10.5% of those receiving cyclosporine A (

 <.0001), with a shorter median time to immunologic remission (1.1 vs 3.0 months; 

Risks of treatment failure (HR, 0.04; 95% CI, 0.01 to 0.11; 

<.0001) and relapse (HR, 0.07; 95% CI, 0.03 to 0.21;

<.0001) were decreased with MIL62 amd improvements in eGFR and quality of life were increased in the MIL62 patient population. Between both patient populations, safety profiles were broadly comparable, and MIL62 demonstrated no new safety signals.

“MIL62 significantly improved remission rates, accelerated disease control, and preserved kidney function versus cyclosporine, with acceptable safety,” wrote Zhao Cui, MD, associate professor at Peking University, and colleagues. “These results support MIL62 as a promising therapeutic option for Primary MN.”

Cui Z, Wei M, Li P, et al. Efficacy and Safety of MIL62, a Glycoengineered Type II Anti-CD20 Antibody, in Primary Membranous Nephropathy: A Phase 3, Randomized, Controlled Trial. October 2025 - Volume 36 - Issue 10S: Journal of the American Society of Nephrology. Published online October 2025. Accessed November 18, 2025. 

Alok A, Yadav A. Membranous Nephropathy. StatPearls. Published June 5, 2023. Accessed November 18, 2025 

https://www.ncbi.nlm.nih.gov/books/NBK559169/

MIL62, a glycoengineered anti-CD20 monoclonal antibody, demonstrated superior efficacy over cyclosporine A in achieving complete remission in adults with primary membranous nephropathy (MN) in a phase 3 trial. The study showed significantly higher remission rates and faster disease control with MIL62, alongside improved renal function and quality of life. While both treatments had comparable safety profiles, MIL62 effectively addressed the autoimmune drivers of MN, reducing relapse and treatment failure risks. These findings suggest MIL62 as a promising therapeutic option for primary MN.

Phase 3 trial shows MIL62 accelerates remission, reduces relapse risk, and improves kidney function compared with cyclosporine A in adults with primary MN.


MIL62 Shows Increased Remission and Reduced Relapse Versus Cyclosporine A in MN

Diana Isaacs, PharmD, is an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic.

Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!

Diabetes Dialogue: Updates on Dexcom G7 and Semaglutide Pricing

In this episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and co-director of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, review two major developments in diabetes care: the forthcoming 15-day Dexcom G7 continuous glucose monitor (CGM) and significant new price reductions for semaglutide across Ozempic and Wegovy.

00:00:01 Introduction
00:00:30 Dexcom G7
00:01:55 A 15-Day Sensor With a 12-Hour Grace Period
00:04:27 Seamless transition to the new G7
00:05:23 Looking back at Dexcom's advancements
00:06:34 Dexcom's Smart Basal feature
00:10:34 Price cuts for semaglutide - Wegovy and Ozempic
00:14:54 Cheaper GLP-1s on the pharmacies' end
00:20:33 Outro

Isaacs and Bellini first outline Dexcom’s announcement that the 15-day G7 sensor will launch on December 1 through durable medical equipment channels, with pharmacy availability to follow shortly afterward. The extended-wear sensor maintains the same form factor, app platform, and accuracy profile users expect, now with a 15.5-day life enabled by a built-in 12-hour grace period. Integration with Omnipod 5 and iLet will be available at launch, with Control-IQ+ compatibility expected later. Both hosts emphasize how reduced sensor-change burden and seamless pump integration can streamline therapy, particularly as CGM adoption accelerates in primary care and among people with 

. They note, however, that the initial FDA clearance is limited to adults 18 and older, with pediatric expansion expected as post-market data develop.

The hosts also highlight advances in data-sharing and the newly cleared Smart Basal feature within the G7 15-day app experience. This tool uses CGM-driven analytics to support clinicians and patients in basal insulin titration, particularly for glargine. The system adjusts doses based on comprehensive glycemic patterns rather than isolated fasting values, incorporates customizable hypoglycemia safeguards, and identifies a final “optimal dose” once glucose stabilizes. Isaacs and Bellini underscore the potential impact for primary care, where under-titration of basal insulin is common and follow-up intervals can be lengthy.

The conversation then shifts to sweeping pricing updates for semaglutide. New self-pay pricing allows patients to access Ozempic for $199 for the first two months and $349 thereafter—a steep reduction from previous cash prices. Wegovy pricing aligns similarly across all doses. While acknowledging that affordability remains a challenge for many, the hosts view this as a substantial improvement, bringing U.S. pricing closer to international norms and potentially expanding access for individuals who fall between traditional insurance coverage and patient-assistance eligibility. They also note updated criteria for assistance programs, ongoing availability of copay cards, and similar price reductions for tirzepatide’s Zepbound starter dose. Practical considerations for pharmacies, insurance dynamics, and cash-pay logistics are discussed, with the hosts optimistic about simplified access and broader uptake.

They conclude by emphasizing how these advances - longer-wear CGM technology, AI-supported insulin titration, and more accessible incretin-based therapies - collectively strengthen the future of diabetes management and expand opportunities for improved outcomes across clinical settings.

Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.

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