Victoria Johnson joined MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and is now an assistant managing editor for HCPLive and RheumatologyLive. She doesn’t have enough time for her numerous hobbies. You can reach her at vjohnson@mjhlifesciences.com.

Victoria Johnson

 as a disease state commanded a notable share of the late-breaking data presented at the 

2026 American Academy of Dermatology (AAD) Annual Meeting

 in Denver, Colorado, with research spanning a broad and rapidly evolving therapeutic landscape, from established biologics accumulating long-term comparative and extension data to emerging oral medications designed to meaningfully shift how psoriasis is managed in the years to come.

Several themes ran through much of the psoriasis program, including the growing momentum behind oral targeted treatments and the continued push to validate sustained skin clearance well beyond the 16-week primary endpoints known to have historically defined the field. Nail psoriasis and generalized pustular psoriasis (GPP) also featured in the data released at the meeting, reflecting a broader effort to address the full clinical spectrum of psoriatic disease. The following 6 updates from AAD represent key trials clinicians managing psoriasis should know:

ONWARD: Oral Envudeucitinib Demonstrates High PASI Responses in Phase 3, With Andrew Blauvelt, MD

One set of trials from AAD was ONWARD1 and 2, highlighting new phase 3 data for envudeucitinib. This drug, a next-generation, highly selective oral TYK2 inhibitor, demonstrating robust skin clearance in moderate-to-severe plaque psoriasis, was discussed by Andrew Blauvelt, MD, MBA, owner of Blauvelt Consulting, LLC, and principal investigator on the ONWARD program. Both ONWARD1 and ONWARD2 together enrolled more than 1700 adult patients living with moderate-to-severe plaque psoriasis.

Sustained PASI Responses Observed Through Week 60 with Zasocitinib, With Melinda Gooderham, MD

The LATITUDE trial program, highlighted during the AAD late-breaking data sessions, suggests zasocitinib could help to reshape the oral treatment landscape for moderate-to-severe plaque psoriasis. The drug was shown to have a high level of skin clearance, a result typically seen with biologics. Melinda Gooderham, MD, medical director of the SKiN Centre for Dermatology in Ontario, Canada, spoke about these key findings from the pair of pivotal phase 3 studies evaluating zasocitinib against both placebo and an active comparator, apremilast.

Risankizumab Outperforms Deucravacitinib on Psoriasis Clearance Across Patient Subgroups in Phase 4 Head-to-Head Trial

Risankizumab was another drug with new data presented during AAD, with findings demonstrating significantly greater skin clearance than deucravacitinib at the 16-week mark across an array of patient subgroups among adults with biologic-naïve moderate plaque psoriasis. These new data resulted from a subgroup analysis of the phase 4 IMMpactful trial, with the findings highlighting subgroup populations defined by race, sex, age, smoking status, baseline disease severity, body mass index (BMI), and presence of psoriatic arthritis (PsA).

ICONIC-LEAD: 1 Year Icotrokinra Data Confirm Durable Psoriasis Clearance, PRO Improvements in Adults, Adolescents, With Jennifer Soung, MD

Icotrokinra was another drug spotlighted during AAD, with 1-year data from the phase 3 ICONIC-LEAD trial confirming icotrokinra delivered durable skin clearance and meaningful patient-reported improvements among adults and adolescents with moderate-to-severe plaque psoriasis. ICONIC-LEAD investigators also identified no new safety signals through the 52-week mark. This medication became the first and only targeted oral peptide blocking the interleukin (IL)-23 receptor after being approved by the United States Food and Drug Administration (FDA) on March 18, 2026, for psoriasis.

Tildrakizumab Sustains Nail Psoriasis Efficacy Through 52 Weeks in Phase 3b Extension Data

New 52-week results also released during AAD showcased a phase 3b trial of tildrakizumab treatment of moderate-to-severe nail psoriasis, with these data demonstrating continued improvement in the level of nail clearance and sustained response seen among early responders, extending results first reported at last year’s AAD. Thia analysis is the first dedicated phase 3b trial of an IL-23 inhibitor in nail psoriasis.

EFFISAYIL ON: New Long-Term Data Released on Spesolimab Injection for GPP

Results from an ongoing open-label extension analysis were released by LEO Pharma at AAD regarding spesolimab-sbzo in adults with GPP. The EFFISAYIL ON analysis is an open-label extension trial lasting 5 years, designed to examine the long-term efficacy, safety, and tolerability of subcutaneous (SC) spesolimab in those who had previously partaken in either the EFFISAYIL 1 or EFFISAYIL 2 pivotal trials. These findings provide encouraging data suggesting this biologic agent can meaningfully diminish patients’ GPP flare burden over several years of treatment.

Articles

Late-breaking AAD 2026 psoriasis data underscored a shift toward high-efficacy oral targeted therapies and longer-term durability beyond 16-week endpoints. Phase 3 ONWARD1/2 showed strong PASI responses with selective TYK2 inhibitor envudeucitinib in >1700 adults. Pivotal LATITUDE studies reported biologic-like clearance sustained to week 60 with zasocitinib versus placebo and apremilast. Additional updates included risankizumab superiority over deucravacitinib across diverse subgroups, 52-week durability with FDA-approved IL-23R peptide icotrokinra without new safety signals, sustained nail responses with tildrakizumab, and multi-year flare reduction with SC spesolimab in GPP.

This review of new data on psoriasis treatments from AAD 2026 highlights several key trials.

AAD 2026: 6 Psoriasis Trials to Know

March encompassed a number of key updates in the nephrology landscape, including revised clinical practice guidelines from Kidney Disease: Improving Global Outcomes (KDIGO), phase 3 clinical trial data on emerging therapies for 

, and featured content examining the International Society of Glomerular Disease (ISGD)'s latest research advances alongside a deep dive into how neighborhood disadvantage drives kidney disease risk and progression.

In this edition, KDIGO announces a focused update to its 2024 CKD guideline, spotlighting newer pharmacologic agents in the management of CKD progression, including the nonsteroidal mineralocorticoid receptor antagonist finerenone, which has now demonstrated statistically significant eGFR slope improvement in nondiabetic CKD populations in the phase 3 FIND-CKD trial. In IgAN, povetacicept achieved a 52% reduction in urine protein-to-creatinine ratio (UPCR) versus baseline in the RAINIER trial's 36-week interim analysis, reinforcing the therapeutic potential of BAFF/APRIL dual inhibition.

 examines the intersection of social determinants of health and CKD risk, specifically how neighborhood disadvantage may drive disease burden in ways that biomarkers alone cannot capture, alongside a special report from the International Society of Glomerular Disease (ISGD) on the transformative scientific advances reshaping our biological understanding of glomerulonephritis and related conditions over the past five years.

KDIGO Launches Focused Update to 2024 CKD Guideline on Emerging Therapies

KDIGO announced a formal update to the 2024 Clinical Practice Guideline for the Evaluation and Management of CKD, one of the most widely used global resources for CKD evaluation and management. The update will focus on Chapter 3, "Delaying CKD progression and managing its complications," with particular emphasis on medical management using newer therapies in light of the evolving therapeutic landscape.

Finerenone Proves CKD Benefit Extends Beyond Diabetes in FIND-CKD

Bayer announced the phase 3 FIND-CKD trial evaluating finerenone (Kerendia) in adult patients with nondiabetic CKD met its primary endpoint, demonstrating a statistically significant improvement in eGFR slope versus placebo over 32 months. The company indicated it planned to submit the data to the US Food and Drug Administration (FDA) to seek a label expansion into this patient population, which would represent the broadest application of the agent to date across a CKD program spanning more than 20,000 patients in phase 3 trials.

RAINIER: Povetacicept Reduces Proteinuria By 52.0%

Povetacicept met its primary and secondary endpoints in RAINIER, an ongoing phase 3 trial evaluating adults with IgA nephropathy (IgAN), according to a 36-week interim analysis. Vertex Pharmaceuticals announced positive results where povetacicept showed a 52.0% reduction in urine protein to creatinine ratio (UPCR) compared to baseline, with a statistically significant and clinically meaningful 49.8% UPCR reduction compared to placebo (

Crisis Point: The Cause and Calamity, Neighborhood Disadvantage and Kidney Disease

Clinicians often thought of healthcare as having a problem and a solution, but this Crisis Point examined what was going on underneath the surface. With the rising threat of chronic kidney disease, more was at stake than the values measurable in a lab, this piece focused on the detrimental problem of neighborhood disadvantage as both the cause and the calamity of kidney disease.

ISGD and the Fastest 5 Years in Glomerular Disease

For experts from ISGD, the last 5 years were the fastest and most dynamic period in glomerular disease. In this special report, Barbara Gillespie, MD, an adult nephrologist at the University of North Carolina and Chief Medical and Strategy Officer at ISGD, and Toby Huber, MD, head of Internal Medicine at Hamburg-Eppendorf in Germany and founding president of ISGD, broke down the scientific advances and how they revolutionized biological understanding of glomerular diseases.

March nephrology developments centered on guideline refinement, late-stage trial readouts, and broader disease drivers. KDIGO is issuing a focused update to the 2024 CKD guideline, emphasizing Chapter 3 and integrating newer agents for slowing progression and managing complications. Phase 3 FIND-CKD data showed finerenone significantly improved eGFR slope in nondiabetic CKD over 32 months, supporting a potential FDA label expansion. In IgA nephropathy, povetacicept produced robust proteinuria reductions at 36 weeks. Additional coverage highlighted neighborhood disadvantage as a key CKD determinant and rapid glomerular-disease mechanistic advances.

Catch up on the guideline updates, trial news, and featured content from March 2026. 


5 Nephrology Headlines You Missed in March 2026

The first quarter of 2026 established a brisk regulatory pace that Q2 shows no signs of slowing. In the span of 3 months, the 

United States Food and Drug Administration

 (US FDA) cleared deucravacitinib for psoriatic arthritis (PsA) — the first TYK2 inhibitor approved for the indication — navepegritide for achondroplasia, and sublingual epinephrine film as the first needle-free epinephrine option for anaphylaxis. The Commissioner's National Priority Voucher program continued to make headlines, most recently with the fastest New Molecular Entity (NME) approval since 2002 in early April.

Q2 now arrives with a calendar that spans nephrology, endocrinology, cardiology, pulmonology, and dermatology — and that carries several decisions with genuine first-in-class or first-in-indication stakes. April brings what could be a long-awaited milestone for the rare kidney disease community, with a ruling expected on sparsentan in focal segmental glomerulosclerosis, a condition affecting more than 40,000 patients in the US for which no approved pharmacologic therapy currently exists. May narrows to a single high-profile call on whether to approve inhaled insulin for children and adolescents ages 4–17 — a decision that, if favorable, would represent the first needle-free insulin option for pediatric patients in over a century of insulin therapy. June closes the quarter with 3 decisions clustered near month's end: cytisinicline's potential to become the first new smoking cessation pharmacotherapy in nearly 20 years, a pediatric label expansion for roflumilast cream, and a pair of cardiometabolic rulings on olezarsen and baxdrostat that could introduce first-in-class mechanisms to severe hypertriglyceridemia and treatment-resistant hypertension, respectively. 

Here are the 6 FDA decisions to watch in Q2 2026, listed chronologically by expected decision date.

 Focal segmental glomerulosclerosis (FSGS) in adults

 The FDA extended the review timeline for the supplemental New Drug Application (sNDA) of sparsentan (Filspari) for focal segmental glomerulosclerosis, pushing the PDUFA date from January 13, 2026, to April 13, 2026, following Travere's submission of additional data requested by the FDA to further characterize the drug's clinical benefit — with no safety or manufacturing concerns raised. Sparsentan is a non-immunosuppressive, oral medication that directly targets podocyte injury by selectively blocking the endothelin A receptor and the angiotensin II subtype 1 receptor, with the sNDA supported by the phase 3 DUPLEX and phase 2 DUET studies. While DUPLEX achieved its pre-specified interim FSGS partial remission of proteinuria endpoint with statistical significance at 36 weeks, it did not achieve the primary efficacy eGFR slope endpoint over 108 weeks of treatment. Two-year DUPLEX data published in the 

 showed significant proteinuria reduction, higher remission rates, and a lower rate of end-stage kidney disease compared to active control irbesartan.

2. Insulin Human Inhalation Powder (Afrezza) 

 Type 1 or type 2 diabetes in children and adolescents aged 4–17 years

 MannKind's sBLA for Afrezza in pediatric patients is supported by phase 3 INHALE-1 study results, which compared Afrezza in combination with a basal insulin against multiple daily injections in children and adolescents with type 1 or type 2 diabetes. Notably, the INHALE-1 study did not meet its primary endpoint of noninferiority with respect to HbA1c, but investigators reported greater treatment satisfaction and reduced weight gain in the Afrezza arm — points the FDA will weigh in its benefit-risk assessment. If approved, Afrezza would offer young children and teenagers with diabetes a potential alternative to multiple daily injections or an insulin pump system — representing the first needle-free insulin option for pediatric patients since insulin therapy was first developed over a century ago.

 Nicotine dependence for smoking cessation in adults

 The NDA for cytisinicline is supported by data from more than 2,000 participants in the phase 3 ORCA-2 and ORCA-3 trials, where cytisinicline demonstrated significantly higher smoking abstinence rates compared to placebo. Cytisinicline is a plant-derived alkaloid that acts on nicotinic acetylcholine receptors, reducing nicotine craving and the rewarding properties of tobacco use. Its receptor selectivity profile has been associated with a lower rate of nausea than older agents, a tolerability advantage the company has emphasized ahead of the review. The drug carries Breakthrough Therapy designation for the separate indication of e-cigarette or vaping cessation. If approved for smoking cessation, cytisinicline has the potential to become the first new FDA-approved treatment option in nearly 20 years — entering a market still anchored by varenicline and nicotine replacement therapy.

 Hard-to-control hypertension as add-on to antihypertensive therapy in adults

 The BaxHTN trial demonstrated a −14.5 to −15.7 mmHg change in systolic blood pressure with baxdrostat compared to −5.8 mmHg with placebo, and AstraZeneca expects the FDA to act on the NDA during Q2 2026 following Priority Review acceptance and the use of a Priority Review voucher. Baxdrostat selectively inhibits aldosterone synthase (CYP11B2), reducing aldosterone production without meaningfully affecting cortisol — a mechanistic specificity that distinguishes it from older antihypertensive classes. The phase 3 BaxHTN results, published simultaneously in the 

 and presented at the European Society of Cardiology 2025, met the primary and all secondary endpoints. If approved, baxdrostat would become the first aldosterone synthase inhibitor authorized for clinical use.

 Severe hypertriglyceridemia (sHTG; triglycerides ≥500 mg/dL) in adults

 The sNDA for olezarsen in severe hypertriglyceridemia was granted Priority Review by the FDA on the strength of phase 3 CORE and CORE2 data, which across 1,061 patients demonstrated a placebo-adjusted mean reduction in triglycerides of up to 72.2% at 6 months and an 85% relative reduction in acute pancreatitis events — results published in the 

 and accompanied by the FDA's Breakthrough Therapy designation in November 2025. Olezarsen is an antisense oligonucleotide targeting apolipoprotein C-III, dosed once monthly by subcutaneous injection. The drug is already approved as Tryngolza for the rarer indication of familial chylomicronemia syndrome; the sHTG sNDA represents a meaningful expansion into a larger patient population.

 Plaque psoriasis in children aged 2 to 5 years

 The FDA accepted Arcutis's sNDA for roflumilast (Zoryve) cream 0.3% to expand the plaque psoriasis (PsO) indication to children aged 2–5 years, assigning a PDUFA date of June 29, 2026. Roflumilast cream 0.3% is currently approved for plaque psoriasis in adults and children down to age 6. The sNDA is supported by a 4-week Maximal Usage Systemic Exposure study in children aged 2–5 demonstrating minimal-to-no systemic absorption, as well as long-term open-label data showing sustained efficacy and tolerability across age groups. Plaque psoriasis in this younger age group commonly affects sensitive areas including the face and intertriginous regions, where steroid use is particularly challenging. If approved, roflumilast cream 0.3% would be the first topical PDE4 inhibitor indicated for plaque psoriasis in children as young as 2, adding to a portfolio that already includes approvals in atopic dermatitis (ages 2+) and seborrheic dermatitis.

Travere Therapeutics. Travere Therapeutics announces FDA acceptance of sNDA for FILSPARI® (sparsentan) in FSGS. Business Wire. May 2025. 

https://ir.travere.com/press-releases/news-details/2025/Travere-Therapeutics-Announces-FDA-Acceptance-of-sNDA-for-FILSPARI-sparsentan-in-FSGS/default.aspx

US Food and Drug Administration. FDA approves first new molecular entity under National Priority Voucher program. FDA.gov. April 1, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-approves-first-new-molecular-entity-under-national-priority-voucher-program

Q2 2026 FDA action dates feature multiple potential first-in-class or first-in-indication decisions across nephrology, endocrinology, cardiometabolic disease, smoking cessation, and dermatology. A pivotal near-term ruling targets sparsentan for FSGS amid mixed eGFR outcomes but durable proteinuria and remission signals. Pediatric inhaled insulin faces a benefit–risk test after missing HbA1c noninferiority yet improving satisfaction and weight outcomes. Late June concentrates decisions on cytisinicline for nicotine dependence, baxdrostat for resistant hypertension, olezarsen for severe hypertriglyceridemia, and expanded pediatric labeling for roflumilast cream.

Check out 6 FDA decisions to watch in Q2 2026, listed chronologically by expected decision date.

Q2 2026 Preview: 6 FDA Decisions to Watch

Atopic dermatitis commanded a substantial share of the late-breaking program at the 

 held in Denver, Colorado, from March 27-31, with data spanning the full arc of the therapeutic pipeline — from approved agents accumulating long-term real-world and extension data to investigational mechanisms that could reshape how the disease is managed altogether. Two themes ran through much of the atopic dermatitis  program: the continued push to extend treatment options to younger pediatric populations, where approved choices remain limited, and a growing body of evidence on durability that moves the field's benchmark from short-term response to sustained, multi-year disease control. Here are 6 updates from the meeting that clinicians managing atopic dermatitis should know.

Tapinarof Cream Clears Skin, Eases Itch Within 1 Week in Kids as Young as 2

Data from the pivotal phase 3 ADORING 1 and ADORING 2 trials, discussed at AAD 2026 by Linda Stein Gold, MD, director of dermatology clinical research at Henry Ford Health System, showed that once-daily tapinarof cream 1% demonstrated early and sustained improvements in both disease signs and symptoms, including itch, in patients aged 2 years and older with moderate-to-severe atopic dermatitis — a population in which approximately 80% of trial participants were children or adolescents and the study cohort was racially and ethnically diverse with high representation of patients with skin of color. Clinical improvements were observed as early as week 1, with skin clearance and itch relief continuing to accrue over the full 8-week treatment period. The nonsteroidal mechanism addresses a longstanding need for steroid-sparing topical options that can be applied continuously to any body site, including the face, without the safety concerns that have historically limited corticosteroid use in young children.

Late-Breaking Data Highlight Nemolizumab Efficacy in Children With Atopic Dermatitis

Phase 2 data presented in a late-breaking session by Lawrence Eichenfield, MD, professor of dermatology and pediatrics at UC San Diego and chief of pediatric dermatology at Rady Children's Hospital, showed that nemolizumab was well tolerated and effective in children aged 2 to 11 years with moderate-to-severe atopic dermatitis, producing clinically meaningful and sustained reductions in skin lesions and itch for up to a year.  IGA 0/1 was observed as early as week 4, with 41–47% of patients achieving it by week 16 — responses sustained through week 52. Skin lesion reductions were considered clinically meaningful at week 4 and were sustained through week 52, and clinically meaningful reductions in itch were noted at week 1 and similarly sustained through week 52, with no serious adverse events reported. The findings extend nemolizumab's established profile in adults and adolescents down to a younger population with limited approved options, setting the stage for potential label expansion of the IL-31Rα antagonist.

Tolerability of Roflumilast Cream 0.05% in Infants with Eczema, With Lawrence Eichenfield, MD

REZOLVE-AD: Rezpegaldesleukin Shows Consistent Efficacy Across Atopic Dermatitis Severity

Raj Chovatiya, MD, PhD, MSCI, FAAD, associate professor at Rosalind Franklin University and founder and director of the Center for Medical Dermatology and Immunology Research in Chicago, presented phase 2b REZOLVE-AD findings showing rezpegaldesleukin achieved dose-dependent, statistically significant improvements in atopic dermatitis outcomes across both moderate and severe disease — with consistent EASI responses observed regardless of baseline severity, geographic region, or asthma comorbidity status. On the primary endpoint, the highest-dose arm achieved a 61% mean EASI reduction versus 31% for placebo (

 <.001). Chovatiya highlighted the consistency across baseline vIGA scores of 3 and 4 as a potential differentiator from standard-of-care biologics, which can show attenuated responses in more severe patients. The phase 3 ZENITH-AD program is in final planning with initiation expected in Q2 2026, with Chovatiya noting that the Treg-modulating mechanism raises the prospect of extended dosing intervals or treatment breaks — a meaningfully different proposition from the continuous cytokine inhibition model that defines the current standard of care.

REZOLVE-AD: Rezpegaldesleukin Shows Consistent Efficacy Across Atopic Dermatitis Severity, With Raj Chovatiya, MD, PhD

TRACE: Tralokinumab Data for Atopic Dermatitis in Skin of Color

A post-hoc analysis from the TRACE real-world study, presented by April Armstrong, MD, MPH, professor and chief of dermatology at UCLA's David Geffen School of Medicine, found that 80.4% of patients with skin of color and moderate-to-severe atopic dermatitis who were treated with tralokinumab achieved at least 1 clinically meaningful disease control endpoint — defined as IGA 0/1, EASI ≤7, or SCORAD <10 — at 12 months. Across the overall study population of 824 patients, 91% achieved at least 1 moderate treatment target after 12 months of tralokinumab use, with approximately three-quarters meeting both clinician-reported and patient-reported moderate endpoints and nearly half attaining optimal targets consistent with minimal disease activity. The skin of color analysis carries particular clinical weight given the historically underrepresented enrollment of Fitzpatrick type IV–VI patients in AD trials and the distinct disease manifestations — including lichenification and postinflammatory dyspigmentation — that can complicate assessment and management in this population.

TRACE: Tralokinumab Data for Atopic Dermatitis in Skin of Color, With April Armstrong, MD, MPH

RADIANT-AD: Rademikibart Effective Over 52 Weeks in Atopic Dermatitis

Cheng Zhou, MD, of Peking University People's Hospital and an investigator in the RADIANT-AD trial, described phase 3 results showing rademikibart produced rapid, clinically meaningful improvements in adults and adolescents with moderate-to-severe atopic dermatitis, with responses that continued to deepen and were sustained through 52 weeks rather than reaching an early plateau. EASI-75 response at week 16 was 74.2% versus 34.4% for placebo, with antipruritic effects and skin lesion clearance also observed at week 16 and maintained through week 52. Notably, rademikibart was associated with lower rates of conjunctivitis — 3.9% at week 16 and 6.3% at week 52 — compared with other agents in its class, addressing a known concern with IL-4/IL-13 pathway inhibition. No FDA submission timeline has been publicly disclosed, as the trial was conducted in China by partner Simcere Pharmaceutical.

Lebrikizumab for Atopic Dermatitis Leads to 4 Years of Clearance, Itch Reduction

Interim findings from the first year of the ongoing phase 3b ADlong study, presented at AAD, showed that 94% of patients achieved meaningful skin improvement (EASI-75) with up to 4 years of lebrikizumab treatment, with 75% achieving near-complete skin clearance (EASI-90) and 78% experiencing meaningful itch relief (Pruritus NRS ≤4). Notably, these outcomes were largely achieved with monotherapy, as 77% of those assessed did not require concomitant systemic or topical treatments, and approximately 80% maintained disease control without the use of topical corticosteroids — with 80% of subjects achieving clinical responses while on once-monthly injections. Safety in the first year of ADlong was consistent with lebrikizumab's established profile, with no new signals identified. The ADlong study remains ongoing with an additional year of follow-up planned.

Atopic dermatitis clinical development is increasingly defined by earlier intervention in pediatrics and longer-duration efficacy benchmarks. Phase 3 data supported rapid, steroid-sparing topical benefit with tapinarof starting in week 1 for patients ≥2 years, while pediatric nemolizumab demonstrated sustained lesion and pruritus control through 52 weeks. Novel immunomodulation with rezpegaldesleukin showed severity-agnostic, dose-dependent EASI improvements, with phase 3 planning underway. Real-world tralokinumab outcomes reinforced effectiveness in skin of color. Longer-term biologic datasets for rademikibart and lebrikizumab emphasized durable responses and tolerability.

Read 6 updates from the meeting that clinicians managing atopic dermatitis should know.