Nephrology news in the third quarter of 2026 included 5 US Food and Drug Administration (FDA) approvals across IgA nephropathy (IgAN), chronic kidney disease (CKD), and nephrotic syndrome, along with 2-year trial data for therapies first approved on the basis of proteinuria.

IgAN accounted for much of the quarter's regulatory activity. Atacicept (Trutakna) received accelerated approval in July, and final ORIGIN 3 data in September showed it preserved kidney function through 2 years. Iptacopan (Fabhalta) converted to full approval on 2-year data, and 2-year VISIONARY results for sibeprenlimab (Voyxact) will support an application for traditional approval.

In CKD, finerenone (Kerendia) gained an indication for patients with type 1 diabetes, while FIND-CKD data extended its evidence to nondiabetic CKD. Obinutuzumab (Gazyva) was approved for childhood-onset idiopathic nephrotic syndrome and remains under priority review in primary membranous nephropathy.

Coverage also focused on detection and access. A joint European Society of Cardiology (ESC) and European Renal Association (ERA) guideline recommended CKD screening for every patient newly diagnosed with cardiovascular disease, the American Kidney Fund highlighted how often CKD goes undiagnosed, and new research found that fewer than half of patients referred for kidney transplant begin evaluation.

Catch up on the quarter's nephrology coverage from the HCPLive editorial team below.

FDA Approvals and Regulatory Decisions

FDA Approves Atacicept (Trutakna) for IgA Nephropathy

On July 7, 2026, the FDA granted accelerated approval to atacicept-vymj (Trutakna), a dual B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL) inhibitor, to reduce proteinuria in adults with primary IgAN at risk of progression. The decision was based on an interim ORIGIN 3 analysis showing a 42% reduction in proteinuria versus placebo at 36 weeks.

Final ORIGIN 3 data reported in September showed atacicept reduced the risk of kidney disease progression by 76% compared with placebo in 428 patients. Annualized estimated glomerular filtration rate (eGFR) decline through 104 weeks was 0.6 mL/min/1.73 m² per year with atacicept and 5.6 with placebo. Vera Therapeutics plans to submit for full approval in the fourth quarter of 2026.

Related: Atacicept Cuts IgAN Progression Risk 76% in ORIGIN 3 Final Data

FDA Grants Full Approval to Iptacopan (Fabhalta) in IgAN

On July 17, 2026, the FDA converted the accelerated approval of Novartis' iptacopan (Fabhalta) to traditional approval to slow kidney function decline in adults with primary IgAN at risk of progression.

The decision was supported by 2-year data from the phase 3 APPLAUSE-IgAN trial, in which iptacopan significantly slowed eGFR decline compared with placebo.

FDA Approves Furosemide Injection (Furoscix ReadyFlow) for Edema in HF, CKD

On July 24, 2026, the FDA approved MannKind's Furoscix ReadyFlow, an autoinjector that delivers subcutaneous furosemide, for edema in adults with heart failure (HF) or CKD.

The autoinjector cuts administration time from 5 hours with the existing on-body infusor to under 10 seconds, giving patients an at-home option for fluid overload.

FDA Approves Finerenone (Kerendia) for CKD and Type 1 Diabetes

On September 16, 2026, the FDA approved finerenone (Kerendia) to reduce urinary albumin-to-creatinine ratio (UACR) in adults with CKD associated with type 1 diabetes.

In the phase 3 FINE-ONE trial, finerenone reduced UACR by 28% compared with placebo at month 6. Hyperkalemia occurred in 10.1% of patients receiving finerenone and 3.3% receiving placebo.

FDA Approves Obinutuzumab (Gazyva) for Idiopathic Nephrotic Syndrome / FDA Grants Obinutuzumab Priority Review as Primary Membranous Nephropathy's Potential First Therapy

On September 25, 2026, the FDA approved obinutuzumab (Gazyva) for relapse prevention in patients aged 2 years and older with frequently relapsing or steroid-dependent childhood-onset idiopathic nephrotic syndrome in complete remission. In the phase 3 INShore trial, 95.5% of patients receiving obinutuzumab maintained complete remission at week 52, compared with 73.2% receiving mycophenolate mofetil.

Earlier in the quarter, on July 14, 2026, the FDA granted priority review to obinutuzumab in primary membranous nephropathy. In the phase 3 MAJESTY trial, 36.9% of patients achieved complete remission at 2 years versus 5.7% with tacrolimus. A decision is expected by November 2026.

Trial Data in IgAN and CKD

Kidney Compass: VISIONARY 2-Year eGFR Data in IgA Nephropathy

On August 3, 2026, Otsuka announced 2-year results from the phase 3 VISIONARY trial showing that sibeprenlimab (Voyxact), an anti-APRIL antibody, returned the annualized rate of kidney function decline in IgAN to a near-physiologic level.

On Kidney Compass, Dana Rizk, MD, of the University of Alabama at Birmingham, reported an annualized eGFR slope of +0.3 mL/min/1.73 m² per year with sibeprenlimab versus a decline of 4.2 with placebo. Sibeprenlimab received accelerated approval in November 2025, and the eGFR data will support a supplemental application for traditional approval.

Related: Sibeprenlimab (Voyxact) Stabilizes Kidney Function in IgAN

Kidney Compass: FIND-CKD Extends Finerenone's Benefit to Non-Diabetic CKD

The phase 3 FIND-CKD trial found that finerenone slowed eGFR decline and reduced cardiorenal risk by 23% in nondiabetic CKD over 32 months. Rajiv Agarwal, MD, MS, discussed how the results extend finerenone's evidence beyond diabetic kidney disease.

On Kidney Compass, Brendon Neuen, MBBS, PhD, reviewed a prespecified glomerulonephritis subgroup analysis showing consistent benefit across IgAN, focal segmental glomerulosclerosis, and membranous nephropathy.

Related: FIND-CKD Expands Finerenone Evidence Beyond Diabetic CKD, With Rajiv Agarwal, MD

Screening, Detection, and Access

New ESC, ERA Guideline Calls for Universal CKD Screening in Cardiovascular Disease

The ESC and ERA published their first joint guideline on cardiovascular disease and CKD, recommending screening with both eGFR and UACR for all patients with newly diagnosed cardiovascular disease.

The guideline also recommends statin-based therapy regardless of lipid levels and expanded use of sodium-glucose cotransporter 2 (SGLT2) inhibitors, finerenone, and semaglutide in CKD.

Nearly 9 in 10 US Adults With CKD Don't Know They Have It, With Pranav Garimella

Pranav Garimella, MBBS, MPH, chief medical officer of the American Kidney Fund, discusses why 87% of US adults with CKD are unaware of their diagnosis and what the US Preventive Services Task Force (USPSTF) should consider in its evidence review on CKD screening.

He covers gaps in eGFR and UACR testing among patients with type 2 diabetes, high-risk groups for screening, and the need for repeat testing to confirm CKD.

Why Fewer Than Half of Referred Patients Reach Kidney Transplant Evaluation

NYU Langone investigators used electronic health record data from 1850 hospitals to track 720,348 patients referred for kidney transplant. Of those, 48% began evaluation, 19% were waitlisted, and 10% underwent transplant.

Patients with severe obesity, those in rural areas, and those treated at small centers or programs in the South were less likely to progress. Allan B. Massie, PhD, encouraged nephrologists to follow up with patients after referral.