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Nephrology in July 2026: FDA approvals for atacicept, iptacopan, and Furoscix in IgAN/CKD, plus new IgAN and CKD trial data.
July was a landmark month for nephrology, headlined by a wave of US Food and Drug Administration (FDA) regulatory action in IgA nephropathy (IgAN) and a first-ever regulatory pathway forming for primary membranous nephropathy (pMN).
Within the span of 3 weeks, the FDA granted accelerated approval to a new dual BAFF/APRIL inhibitor, converted a complement inhibitor's accelerated approval to full approval based on 2-year kidney function data, and cleared a needle-free, at-home diuretic option for fluid overload in heart failure (HF) and chronic kidney disease (CKD). Genentech's obinutuzumab also moved a step closer to becoming the first FDA-approved therapy for pMN, while new data from the VISIONARY and FIND-CKD trials expanded the evidence base for sibeprenlimab and finerenone, respectively.
Rounding out the month, new research quantified a persistent access gap in kidney transplant evaluation, and a panel of nephrology experts weighed in on how SGLT2 inhibitors, finerenone, and GLP-1 receptor agonists have reshaped CKD management heading into the second half of 2026.
Below, HCPLive rounds up the 8 nephrology stories that had the biggest clinical and regulatory impact in July 2026, from FDA approvals and priority reviews to new trial data and expert perspective on where CKD care stands today.
On July 7, 2026, the FDA granted accelerated approval to atacicept-vymj (Trutakna), a dual BAFF/APRIL inhibitor, to reduce proteinuria in adults with primary IgAN at risk of disease progression. The decision was supported by a prespecified interim analysis of the phase 3 ORIGIN 3 trial, in which atacicept produced a statistically significant 42% reduction in proteinuria versus placebo at 36 weeks. The once-weekly subcutaneous injection is self-administered via autoinjector.
On July 14, 2026, the FDA granted priority review to Genentech's supplemental biologics license application for obinutuzumab (Gazyva) in primary membranous nephropathy, based on phase 3 MAJESTY data showing 36.9% of patients achieved complete remission at 2 years versus 5.7% with tacrolimus. A decision is expected by November 2026; if approved, obinutuzumab would be the first FDA-approved therapy for this chronic autoimmune kidney disease.
On July 17, 2026, Novartis' iptacopan (Fabhalta) converted from accelerated to traditional FDA approval to slow kidney function decline in adults with primary IgAN at risk of progression. The upgrade was backed by 2-year data from the phase 3 APPLAUSE-IgAN trial, which met its final primary endpoint and demonstrated significantly slower eGFR decline with iptacopan versus placebo, making it the first complement inhibitor to show this durability of benefit in IgAN.
On July 24, 2026, the FDA approved MannKind's Furoscix ReadyFlow, the first and only autoinjector delivering subcutaneous furosemide with IV-equivalent exposure, cutting administration time from 5 hours (with the existing on-body infusor) to under 10 seconds. The at-home option is approved for edema in adults with HF or CKD and is expected to be commercially available by the end of August 2026.
Interim findings from the phase 3 VISIONARY trial showed that sibeprenlimab preserved kidney function over 12 months in adults with IgAN, adding to the growing body of evidence for APRIL-targeted therapies in this progressive disease.
In this interview, Rajiv Agarwal, MD, MS, discusses new phase 3 FIND-CKD results demonstrating reduced eGFR decline with finerenone in patients with nondiabetic CKD—a population representing more than half of all CKD cases. The conversation covers how these findings extend finerenone's evidence base well beyond its original diabetic kidney disease indication and what that could mean for broader use of the nonsteroidal mineralocorticoid receptor antagonist in clinical practice.
New research found that nearly half of kidney transplant candidates referred for evaluation never actually start the process, with access barriers varying significantly by patient background, underscoring a persistent gap between referral and actual transplant workup.
Experts discuss how CKD management has evolved through 2026, covering the maturing roles of SGLT2 inhibitors, finerenone, and GLP-1 receptor agonists, and how clinicians are increasingly personalizing treatment as the drug landscape expands.