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.

The 2026 American Academy of Dermatology Annual Meeting, held March 27–31 in Denver, Colorado

, delivered one of the most consequential late-breaking programs in recent memory—one that may look, in retrospect, like a turning point for oral therapy in immune-mediated skin disease. Plaque psoriasis alone commanded multiple pivotal readouts, with the phase 3 LATITUDE and ONWARD programs for zasocitinib and envudeucitinib respectively positioning a second wave of TYK2 inhibitors as potential biologic-level competitors in a once oral-skeptical space. The message from both datasets was strikingly consistent: high skin clearance rates, rapid onset, durable responses, and safety profiles that don't carry the warnings associated with broader JAK inhibition.

Beyond psoriasis, the meeting made a compelling case that the dermatology pipeline has matured well beyond its traditional boundaries. In hidradenitis suppurativa, two distinct therapeutic approaches—MoonLake's IL-17A/F nanobody sonelokimab and Incyte's oral JAK1 inhibitor povorcitinib—each presented long-term data showing deepening clinical responses through 40 and 54 weeks respectively, raising the bar for what durable disease control looks like in a condition historically defined by high treatment failure rates. The Viti-Up trials offered the field its first phase 3 evidence for a systemic vitiligo therapy, with upadacitinib meeting both co-primary repigmentation endpoints and regulatory submissions now filed with both the FDA and EMA.

The meeting also surfaced two datasets that extend beyond dermatology's traditional scope. Eli Lilly's TOGETHER-PsA trial—the first randomized study to test a biologic plus an incretin therapy against a biologic alone—showed that adding tirzepatide to ixekizumab in patients with PsA and obesity substantially improved both joint and weight outcomes, introducing what investigators called a potential paradigm shift in how systemic inflammation and metabolic disease are managed together. And in alopecia areata, rezpegaldesleukin offered proof of concept for an entirely new mechanism—regulatory T-cell stimulation—in a disease where JAK inhibitors have been the only advanced option. 

Here are 7 updates from AAD 2026 that clinicians should know.

Zasocitinib Demonstrates Sustained PASI Responses Through Week 60

Late-breaking data from the phase 3 LATITUDE trial program, presented by Melinda Gooderham, MD, medical director of the SKiN Centre for Dermatology in Ontario, Canada, showed that zasocitinib achieved approximately 70% sPGA 0/1 and PASI 75 rates at week 16 against both placebo and apremilast, with PASI 75 and PASI 90 responses sustained through week 60—directly addressing a longstanding question about the durability of oral agents in psoriasis. More than 90% of week-40 responders maintained clear or nearly clear skin through week 60, and roughly one-third achieved PASI 100 by week 16. Gooderham framed the results as marking a new era in which an oral agent may deliver biologic-level efficacy, with Takeda planning an NDA submission in fiscal year 2026.

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

ONWARD: Envudeucitinib Demonstrates High PASI Responses in Phase 3

In an interview following his late-breaking presentation, Andrew Blauvelt, MD, MBA, principal investigator on the ONWARD program, described envudeucitinib as a second-generation TYK2 inhibitor engineered specifically for complete 24-hour target coverage—the only TYK2 inhibitor shown to achieve maximal inhibition over a full dosing interval in humans—with the ONWARD1 and ONWARD2 trials enrolling more than 1,700 adults and meeting all primary and secondary endpoints against both placebo and apremilast with high statistical significance. At week 16, approximately 74–75% of patients achieved PASI 75 and 59% achieved sPGA 0/1, with responses deepening through week 24 to include PASI 100 rates approaching 40%. An NDA submission is planned for the second half of 2026, alongside a once-daily extended-release formulation in development.

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

Rezpegaldesleukin Shows Favorable Safety, Durable Responses in Alopecia Areata

David Rosmarin, MD, chair of the Department of Dermatology at Indiana University School of Medicine, presented phase 2b REZOLVE-AA data at AAD showing rezpegaldesleukin—a novel Treg agonist—demonstrated statistically significant hair regrowth in severe-to-very-severe alopecia areata, with efficacy showing no plateau at week 36 and a 16-week extension expected to capture additional responders. The safety profile was reassuring across more than 1,000 patients exposed in 11 studies, with injection site reactions as the most common adverse event and no signals for MACE, thrombosis, serious infection, or malignancy. Rosmarin characterized the mechanism—selective Treg expansion via pegylated IL-2—as genuinely differentiated from JAK inhibitors, the only currently approved advanced option in the disease.

First in Class Rezpegaldesleukin: Favorable Safety, Durable Responses in Alopecia Areata, With David Rosmarin, MD

VELA: Phase 3 Data Suggest Sonelokimab Effective for HS

Week 40 data from the phase 3 VELA-1 and VELA-2 trials, presented by Alexa Kimball, MD, MPH, of Harvard Medical School, showed that 62% of patients treated with sonelokimab achieved HiSCR75 and up to 32% achieved HiSCR100 by week 40, with clinical improvement continuing to build on the response trajectory first established at the 16-week primary endpoint readout. Patients also reported substantial quality-of-life gains, including a 41% reduction in pain and improvements in depression and daily function at week 40. MoonLake Immunotherapeutics indicated plans to file a biologics license application later in 2026, with 52-week data expected in Q2.

VELA: Phase 3 Data Suggest Sonelokimab Effective for HS, With Alexa Kimball, MD, MPH

Povorcitinib Delivers Deepening Responses Through 54 Weeks in Moderate-to-Severe HS

Martina Porter, MD, of Harvard Medical School and Beth Israel Deaconess Medical Center, presented 54-week data from the STOP-HS1 and STOP-HS2 trials showing povorcitinib achieved HiSCR50 in up to 71% of patients, HiSCR75 in up to 57%, and HiSCR100 in up to 29%, with full clearance of all inflammatory lesions in up to 20% of patients—adding a mechanistically distinct oral JAK1 option to a treatment landscape anchored to injectable biologics. The safety profile through 54 weeks was consistent with prior 24-week data, with acne, nasopharyngitis, and upper respiratory infection among the most common TEAEs and no new signals of concern. Porter positioned JAK-STAT pathway inhibition as genuinely complementary to existing IL-17 and TNF inhibitors, with particular potential for biologic-experienced patients who have not responded adequately.

Povorcitinib Delivers Deepening Responses Through 54 Weeks in Moderate-to-Severe HS, With Martina Porter, MD

Next Steps for Upadacitinib in Non-Segmental Vitiligo

Phase 3 Viti-Up-1 and Viti-Up-2 data presented by Thierry Passeron, MD, PhD, professor and chair of the Department of Dermatology at the Université Côte d'Azur in Nice, France, showed that upadacitinib 15 mg once daily met both co-primary endpoints of T-VASI 50 and F-VASI 75 at week 48 in adults and adolescents with non-segmental vitiligo, with continuous improvement observed over the treatment period and no new safety signals or MACE identified. Passeron emphasized the importance of expectation management for patients seeking complete clearance, noting vitiligo repigmentation is a slower process than psoriasis or atopic dermatitis. Regulatory submissions to both the FDA and EMA have been filed, and if approved, upadacitinib would become the first systemic therapy indicated for vitiligo.

Upadacitinib Safe, Effective Over 48 Weeks for Non-Segmental Vitiligo, With Thierry Passeron, MD, PhD

TOGETHER-PsA: Ixekizumab Plus Tirzepatide Delivers Superior Efficacy Over Biologic Monotherapy

Detailed results from the phase 3b TOGETHER-PsA trial, presented at AAD and simultaneously published in 

, showed that in 271 adults with active PsA and obesity or overweight, 31.7% receiving concomitant ixekizumab and tirzepatide achieved the composite primary endpoint of ACR50 plus ≥10% weight reduction at 36 weeks, versus 0.8% on ixekizumab monotherapy, with improvements in disease activity, fatigue, physical function, and cardiometabolic markers also favoring the combination. The findings, presented by Joseph F. Merola, MD, professor and chair of dermatology at UT Southwestern Medical Center, represent the first randomized trial to test whether co-treating obesity alongside a biologic improves PsA outcomes—and suggest that for many patients, cardiometabolic disease may be an underappreciated driver of inadequate biologic response. Eli Lilly indicated it plans to discuss the findings with regulators, though no submission timeline was disclosed.

Together-PsA: Ixekizumab + Tirzepatide Deliver Superior Efficacy Over Biologic Monotherapy, With Joseph Merola, MD

Articles

AAD 2026 data reinforced a major shift toward high-efficacy oral immunomodulators and mechanistically diversified pipelines across immune-mediated skin disease. Second-generation TYK2 inhibitors delivered rapid, high PASI responses with durable maintenance to 60 weeks and without broader JAK-class warnings, supporting biologic-competitive oral positioning. Hidradenitis suppurativa readouts showed deepening, durable responses with both IL-17A/F blockade and oral JAK1 inhibition. Upadacitinib produced the first phase 3 systemic vitiligo repigmentation signal with filings underway. Combination ixekizumab–tirzepatide linked metabolic intervention to superior PsA outcomes.

Check out exclusive expert interviews of late breaking data from AAD 2026.

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Hidradenitis Suppurativa

Hidradenitis Suppurativa condition center page, audiences can find a variety of coverage mediums for medical news and updates, including articles, video interviews, podcasts, and breaking news on dermatology research, treatment, and drug development.

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

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Alopecia

AAD 2026: 7 Late-Breaking Data Updates to Know in Dermatology

Professor Stephen Nicholls is a world-renowned cardiologist, and leads the Victorian Heart Hospital (VHH) at Monash University.

Obicetrapib is Safe and Well-Tolerated in HeFH and ASCVD, With Stephen Nicholls, MD

Obicetrapib has a history of being safe and well-tolerated in patients with 

heterozygous familial hypercholesterolemia (HeFH)

atherosclerotic cardiovascular disease (ASCVD)

, based on a pooled safety analysis of the BROADWAY and BROOKLYN phase 3 trials.

American College of Cardiology (ACC) Scientific Sessions 2026

 in New Orleans, Louisiana, by Stephen Nicholls, MD, director of the Monash Velos Accelerator, program director of MonashHeart, Intensive Care and Victorian Heart Hospital, and director of the Monash Victorian Heart Institute at Monash Health.

“We saw less new onset diabetes, which we’ve seen with other CETP inhibitors, and we’ve also seen some potential favorable effects in slowing the reduction of eGFR,” Nicholls told 

 in an exclusive interview. “I think we need to understand more about potential mechanisms, but most importantly, this reassures me about safety and tolerability, and if we can combine that with better lipid effects and ultimately a reduction in cardiovascular risks, that would be great for patients.”

BROADWAY was a multinational, placebo-controlled, double-blind phase 3 trial including patients with either HeFH or established ASCVD. Additional criteria included being on maximally tolerated lipid-modifying therapy, a fasting serum LDL-C ≥55 to <100 mg/dL or non-DL-C ≥85 mg/dL to <130 mg/dL, and an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73m2 at screening, among others. Patients were excluded if they had NYHA class III or IV 

, left ventricular ejection fraction <30%, or major adverse cardiovascular events within 3 months of screening, among other criteria.

A total of 2530 patients were included in the trial and were randomly assigned to either obicetrapib 10 mg or placebo daily for 365 days. Over the course of the study, eGFR decreased significantly more among patients receiving obicetrapib compared to placebo. LDL-C also changed by a comparatively larger amount in the obicetrapib arm (-29.9%) versus placebo (+2.7%).

The BROOKLYN trial, meanwhile, specifically investigated patients with HeFH who were on maximally tolerated lipid-modifying therapy. Patients were excluded if they had NYHA class II or IV heart failure, last known left ventricular ejection fraction <30%, or had been hospitalized for heart failure within 5 years of screening, among other criteria.

The BROOKYLN investigators enrolled 354 patients and randomly assigned them in a 2:1 ratio to either obicetrapib 10 mg or placebo daily for 365 days. During this time, patients exhibited a placebo-adjusted LDL-C change of -36.3%. Secondary endpoints included changes in apolipoprotein B and non-HDL-C, which decreased by 24.4% and 34.5%, respectively.

For the present safety analysis, Nicholls and colleagues pooled data from both trials for a total of 2880 patients. The frequency of overall treatment-emergent adverse events was similar between obicetrapib and placebo groups (60.2% vs 62%). Adverse events leading to discontinuation were 4.1% and 5.3%, respectively. Among predicted events, dizziness, headache, hypertension, and myalgia were infrequent, while new onset diabetes mellitus, worsening glycemic control, and eGFR decline occurred less frequently with obicetrapib. Additionally, macular degeneration was rare and occurred in only 1 obicetrapib recipient.

“We know that many patients don’t get to goal, and every time we update our guidelines, they tell us that high-risk patients should go lower and lower,” Nicholls said. “But every time we lower the target, we’re going to leave more and more people behind. So, we need effective therapies that we can add to statins. Obicetrapib has the potential to be that therapy.”

Editors’ Note: Nicholls reports disclosures with AstraZeneca, NewAmsterdam Pharma, Amgen, Omthera, Merck, Boehringer Ingelheim, and others.

Nelson A, Kastelein J, Hsieh A, et al. Safety of Obicetrapib: An Integrated Pooled Phase III Safety Analysis. Abstract presented at the American College of Cardiology Scientific Sessions 2026, New Orleans, LA. March 28-30, 2026.

NewAmsterdam Pharma. Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies (BROADWAY). ClinicalTrials.gov Identifier: NCT05142722. Updated September 19, 2025. Accessed April 2, 2026. 

https://clinicaltrials.gov/study/NCT05142722

Nicholls SJ, Nelson AJ, Ditmarsch M, et al. Safety and efficacy of Obicetrapib in patients at high cardiovascular risk. 

NewAmsterdam Pharma. Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies (BROOKLYN). ClinicalTrials.gov Identifier: NCT05425745. Updated June 11, 2025. Accessed April 2, 2026. 

https://clinicaltrials.gov/study/NCT05425745

Nicholls, S.J., Nelson, A.J., Ditmarsch, M. et al. Obicetrapib in patients with heterozygous familial hypercholesterolemia: the BROOKLYN randomized clinical trial. 

https://doi.org/10.1038/s41591-025-04179-4

Videos

Nicholls discusses his recent pooled analysis of safety data from the BROADWAY and BROOKLYN phase 3 trials, proving the tolerable safety of obicetrapib.

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

Dyslipidemia

Atherosclerotic Cardiovascular Disease

Strategic Alliance Partnership

Abigail Brooks is an assistant managing editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

New analyses from the phase 3 VISIONARY trial evaluating Otsuka Pharmaceutical Development & Commercialization’s sibeprenlimab-szsi (Voyxact) in adults with IgA nephropathy (IgAN) at risk for disease progression highlight clinically meaningful improvements across key markers of IgAN.

The data were presented at the 2026 ISN World Congress of Nephrology and reinforce the potential of selectively inhibiting A PRoliferation Inducing Ligand (APRIL), a central driver of disease biology, to meaningfully impact patient outcomes.

“The new VISIONARY analyses highlight the differentiated clinical profile of sibeprenlimab and the potential clinical impact of targeting a key immune driver of the disease,” John Kraus, MD, PhD, executive vice president and chief medical officer, Otsuka, said in a statement. “In addition to meaningful reductions in proteinuria, the observed improvements in hematuria provide complementary evidence of an effect on underlying disease activity. Together, these findings reinforce the potential of [sibeprenlimab] to meaningfully improve clinical outcomes for adult IgAN patients at risk for disease progression.”

Sibeprenlimab is a humanized monoclonal antibody that binds to and blocks APRIL, which plays a key role in the 4-hit process of IgAN pathogenesis and is an important initiating and sustaining factor in IgAN progression by promoting the production of pathogenic galactose-deficient IgA1 (Gd-IgA1). Inhibition of APRIL results in reduced levels of serum Gd-IgA1, which is implicated in the pathogenesis of IgAN. Sibeprenlimab is a self-administered, subcutaneous injection dosed every 4 weeks.

It was granted accelerated approval by the US Food and Drug Administration for reducing proteinuria in primary IgAN in November 2025 based on 12-month data from the VISIONARY trial showing a 54.3% placebo-adjusted reduction in geometric mean 24-hour urine protein-to-creatinine ratio (UPCR) from baseline.

Of note, the accelerated approval was based on reduction of proteinuria. It has not been established whether sibeprenlimab slows kidney function decline over the long-term in patients with IgAN, and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.

The interim VISIONARY analyses presented at WCN showed a greater and faster proportion of patients achieving negative microscopic hematuria (0–5/HPF), an exploratory endpoint reflecting improvement in glomerular injury in IgAN. Among global patients with hematuria at baseline, 82.5% of patients receiving sibeprenlimab were negative for microscopic hematuria at week 48 compared with 52.6% of patients receiving placebo. Median time to achieve negativity for microscopic hematuria (0–5/HPF) was 9 weeks with sibeprenlimab versus 24 weeks with placebo.

As described in a press release from Otsuka, the findings complement robust proteinuria reductions observed with sibeprenlimab. Of note, the safety profile was comparable between sibeprenlimab and placebo.

In a previously prespecified interim analysis of the global main cohort of VISIONARY presented at the European Renal Association (ERA) congress in 2025, sibeprenlimab met the primary endpoint, demonstrating a -51.2% (

<.0001) placebo-adjusted reduction in 24-hour UPCR at 9 months.

The VISIONARY trial is ongoing to evaluate the safety and efficacy of sibeprenlimab in preserving kidney function based on estimated glomerular filtration rate slope over a 24-month treatment period.

Otsuka. Otsuka Showcases New Efficacy and Safety Data of VOYXACT® (sibeprenlimab-szsi) in Patients with IgA Nephropathy (IgAN) at the 2026 ISN World Congress of Nephrology Highlighting the Impact of APRIL Inhibition. March 25, 2026. Accessed April 2, 2026. 

https://www.businesswire.com/news/home/20260324322305/en/Otsuka-Showcases-New-Efficacy-and-Safety-Data-of-VOYXACT-sibeprenlimab-szsi-in-Patients-with-IgA-Nephropathy-IgAN-at-the-2026-ISN-World-Congress-of-Nephrology-Highlighting-the-Impact-of-APRIL-Inhibition

Campbell P. FDA Awards Accelerated Approval to Sibeprenlimab in IgA Nephropathy. HCPLive. November 25, 2025. Accessed April 2, 2026. 

https://www.hcplive.com/view/fda-awards-accelerated-approval-to-sibreprenlimab-in-iga-nephropathy

Campbell P. ERA 2025: Sibeprenlimab Halves Proteinuria in IgAN in Phase 3 VISIONARY Trial. HCPLive. June 6, 2025. Accessed April 2, 2026. 

https://www.hcplive.com/view/era-2025-sibeprenlimab-halves-proteinuria-in-igan-in-phase-3-visionary-trial

New phase 3 VISIONARY interim analyses of sibeprenlimab-szsi (Voyxact) in adults with progressive-risk IgA nephropathy show clinically meaningful improvements in disease activity markers beyond proteinuria. As a humanized anti-APRIL monoclonal antibody, sibeprenlimab targets a key driver of Gd-IgA1 production within IgAN pathobiology and is administered subcutaneously every 4 weeks. Accelerated FDA approval (Nov 2025) was based on proteinuria reduction, while long-term kidney function benefit remains unconfirmed pending ongoing eGFR-slope evaluation over 24 months.

Data presented at the World Congress of Nephrology highlight faster and higher rates of microscopic hematuria negativity with sibeprenlimab treatment.

Nephrology

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

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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.

New VISIONARY Analyses Reinforce Benefits of APRIL Inhibition With Sibeprenlimab in IgAN

Eingun James Song, MD, is the director of clinical research for Frontier Dermatology. 

Key Takeaways on JAK Inhibitors and Black Box Warnings, With Eingun James Song, MD

Eingun James Song, MD, spoke in an interview with 

 about dermatologists’ evolving understanding of Janus kinase (JAK) inhibitors at the 

2026 American Academy of Dermatology (AAD) Annual Meeting

Song, director of clinical research for Frontier Dermatology, emphasized the value of contextualizing safety data and interpreting boxed warnings with an increasing level of nuance. JAK inhibitors, Song noted, have generated significant discussion in recent years, largely given various concerns surrounding safety signals identified in clinical research.

“I think it really comes down to understanding trial designs and the population that are being studied, because whenever you look at clinical data, you have to understand what population or what type of patients were in the study,” Song explained.

In his discussion, Song described boxed warnings, while important, as not unique to JAK inhibitors. He stated they should not be interpreted as definitive indicators of risk across all patient populations. Instead, clinicians should normalize their existence and focus on individualized assessments of risk. Many safety concerns linked with JAK inhibitors, including major adverse cardiovascular events (MACE), were identified in trials involving older, comorbid populations, such as those with rheumatoid arthritis.

Such individuals will likely have a higher baseline risk of adverse events (AEs) independent of JAK use, complicating direct comparisons to dermatologic patient populations. Song additionally highlighted limitations in key studies related to JAK inhibitor therapies. Importantly, he noted, real-world data in dermatologic conditions such as atopic dermatitis and alopecia areata have not demonstrated a consistent rise in AEs among those treated with JAK inhibitors when matched for demographic and clinical risk factors.

“In other words, what I tell a patient is that if you have risk factors, these things are just more likely to happen to you whether or not you take the medication,” Song said. “And based on the data that we have, which admittedly isn't perfect, it doesn't seem to be appreciably higher than what [you] have.”

Emerging data from other indications, including hidradenitis suppurativa and vitiligo, further support JAK inhibitors’ generally favorable safety profile, with Song pointing to lower rates of serious AEs/ Longer-term placebo-controlled data, including 48-week trials, may be warranted to allow for additional reassurance as the evidence base continues to grow.

For further information on this discussion, view the full interview segment posted above.

Song has reported serving as an investigator, consultant, and/or speaker for AbbVie, Alphyn Biologics, Amgen, Apogee, Arcutis, Bristol Myers Squibb, Boehringer Ingelheim, Dermavant, DermBiont, Galderma, Incyte, Janssen, LEO Pharma, MoonLake, Novartis, Ortho, Pfizer, Regeneron, Sanofi, Sun Pharmaceutical Industries, Timber Pharmaceuticals, and UCB.

Song E. F099 JAK Inhibitors in Dermatology: Identifying Ideal Candidates. Sesson presented at: 2026 American Academy of Dermatology Annual Meeting; March 27–31, 2026; Denver, CO.

Smith T. Rethinking the Black Box: JAK Inhibitors Find Their Place in Dermatology. HCPLive. October 21, 2025. April 2, 2026. 

https://www.hcplive.com/view/rethinking-black-box-jak-inhibitors-find-their-place-dermatology

Song speaks about JAK inhibitors and their safety in dermatology care settings, contextualizing previous data on adverse events.

Chelsie Derman is an associate editor for 

who covers allergy and  psychiatry. 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.

FDA removes age requirement for epinephrine nasal spray

FDA grants fast track designation to bw-20805 siRNA therapy for HAE

FDA accepts NDA for bezuclastinib in non-advanced systemic mastocytosis

Viaskin peanut patch shows promise in phase 3 Vitesse trial

March 2026 brought a wave of regulatory updates and emerging therapeutic data across the 

 and immunology space, spanning anaphylaxis management, food allergy desensitization, hereditary angioedema (HAE), systemic mastocytosis, and chronic rhinosinusitis with nasal polyps (CRSwNP). Several developments centered on improving access to emergency therapies and accelerating disease-modifying approaches for IgE-mediated allergy and mast cell–driven conditions. Key updates from the month highlighted advances in noninvasive treatment options, RNA-based therapeutics, and targeted inhibitors with rapid onset of action.

This month in review spotlights the top 6 allergy news stories in March.

FDA Updates: Neffy Label Change, Fast Track for HAE Therapy, & More

FDA Removes Age Requirement for Epinephrine Nasal Spray

The US Food and Drug Administration (FDA) removed the minimum age requirement for 1 mg epinephrine nasal spray, allowing use in any patient weighing ≥ 33 lbs (15 kg). Previously, pediatric use was limited to those aged ≥ 4 years despite weight-based dosing alignment. The updated labeling now bases dosing solely on weight, expanding access to needle-free epinephrine for younger children at risk for anaphylaxis.

The revision also included practical updates, such as guidance for accidental sniffing after administration, allowances for freeze-thaw use, and expanded storage parameters, including temperature excursions up to 122°F. These changes aim to improve real-world usability in settings such as schools and childcare. Approximately 25% of children within the eligible weight range had previously been excluded due to age criteria, underscoring the clinical significance of the labeling change.

FDA Grants Fast Track Designation to BW-20805 siRNA Therapy for HAE

The FDA granted Fast Track designation to Argo Biopharmaceutical’s BW-20805, an investigational small interfering RNA (siRNA) therapy targeting the kallikrein pathway for prophylaxis of HAE. Early phase 2 findings suggest potential sustained suppression of disease activity, though investigators emphasized the preliminary nature of the data and the need for longer follow-up.

The ongoing phase 2 trial is expected to be completed in 2026, with plans for a global phase 3 study thereafter. The designation reflects the therapy’s potential as a long-acting treatment option in a disease requiring ongoing prophylaxis.

Related: BW-20805 Reduces HAE Attacks in Phase 2 Trial, With Markus Magerl, MD

FDA Accepts NDA for Bezuclastinib in Non-Advanced Systemic Mastocytosis

The FDA accepted the new drug application (NDA) for Cogent Biosciences’ bezuclastinib in adults with non-advanced systemic mastocytosis and assigned a PDUFA target action date of December 30, 2026. The agency indicated no planned advisory committee meeting and identified no major review issues at acceptance.

The submission is supported by data from the SUMMIT trial evaluating the selective KIT inhibitor (KIT D816V) in patients with mast cell–driven symptoms. The regulatory milestone signals potential progress toward a targeted oral therapy for a population with limited treatment options.

VIASKIN Peanut Patch Shows Strong Phase 3 VITESSE Results, With David Fleischer, MD

Phase 3 VITESSE trial data demonstrated strong desensitization outcomes with the VIASKIN peanut patch (VP250), an epicutaneous immunotherapy delivering 250 µg peanut protein. Among peanut-allergic children aged 4–7 years, 82.8% receiving VP250 increased their eliciting dose compared with 48% on placebo over 12 months.

The trial met its primary endpoint, with significantly greater responder rates in treated patients across baseline eliciting dose strata (46.3% vs 14.7% and 43.1% vs 14.6%, respectively; 

<.001). Additionally, 60% of participants improved by ≥ 2 dose levels during food challenge testing versus 23.4% on placebo. Investigators highlighted the patch’s noninvasive design and potential for improved adherence compared with oral immunotherapy.

“It's fantastic data to show that epicutaneous immunotherapy, [at] such a low dose, works to desensitize the vast majority of patients to a level that I think will protect them clinically from allergic reactions,” David Fleischer, MD, professor of pediatrics at Children’s Hospital Colorado, told 

Remibrutinib Enables Peanut Tolerance in as Little as 1 Week, With Robert Wood, MD

Phase 2 data presented at the 2026 AAAAI Annual Meeting demonstrated rapid desensitization with remibrutinib, a Bruton’s tyrosine kinase inhibitor. After only 1 week of treatment, 88% of adults with IgE-mediated peanut allergy tolerated a previously reactive dose during oral food challenge. The therapy was well tolerated, with no serious adverse events reported.

Across dose groups, 4 weeks of therapy produced estimated response rates ranging from 0.41 to 0.84, all exceeding placebo. In an interview, Robert Wood, MD, from Johns Hopkins Children's Center, said that the speed of remibrutinib may open up the possibility of the treatment to be used intermittently instead of continuously.

Verekitug Cuts Polyp Size in Severe CRSwNP, With Joseph Han, MD

At AAAAI 2026, HCPLive spoke with Joseph Han, MD, from Old Dominion University, on late-breaking phase 2 VIBRANT data demonstrating that verekitug, a thymic stromal lymphopoietin (TSLP) receptor–blocking therapy, reduced the need for surgery and improved outcomes in severe chronic rhinosinusitis with nasal polyps. Quarterly treatment reduced surgical need by 76% compared with baseline expectations, highlighting the biologic’s potential in severe disease management.

Han emphasized that targeting upstream epithelial cytokines such as TSLP may offer broader anti-inflammatory control compared with downstream biologics, supporting ongoing development in CRSwNP.

March 2026 allergy news: FDA label updates, mastocytosis NDA, and promising data for peanut patch, remibrutinib, and CRSwNP biologics.

Allergy

Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

Food Allergy

Seasonal Allergy

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The HCPLive anaphylaxis page is a comprehensive resource for clinical news and insights on acute allergic reactions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for preventing anaphylaxis, and more.

6 Allergy Headlines You Missed in March 2026

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.

ASH publishes 33 clinical recommendations and 4 good practice statements for the diagnosis and treatment of severe and very severe acquired aplastic anemia. 

Hematology

ASH Publishes Guidelines on Diagnosis and Management of Severe and Very Severe Acquired Aplastic Anemia

Nicholls discusses the investigational oral CETP inhibitor’s effects on kidney health for patients at high risk of cardiovascular disease due to elevated HDL-C.

Chronic Kidney Disease

BROADWAY: Obicetrapib Preserves Kidney Function, Prevents CKD, With Stephen Nicholls, MD 

Marcello Tonelli, MD, is a nephrologist and professor of medicine at the University of Calgary, founding director of the World Health Organization Collaborating Centre on Prevention and Control of Chronic Kidney Disease, and president of the International Society of Nephrology.

The WHO resolution on kidney health elevates kidney disease as a global health priority, emphasizing early detection, treatment, and system-wide action.

Elevating Kidney Disease in Global Health Policy, With Marcello Tonelli, MD

Rajiv Agarwal, MD, MS, is a Professor Emeritus of Medicine at Indiana University School of Medicine and VA Medical Centre in Indianaoplis.

Further CONFIDENCE analyses support safe combination therapy in CKD, with improved responses in key patient subgroups.

CONFIDENCE Trial Insights on CKD Combination Therapy, With Rajiv Agarwal, MD, MS

Pranav Garimella, MBBS, MPH, is chief medical officer of the American Kidney Fund.

New OPTN data shows kidney transplant gains from race-free GFR and restored wait times stall, as structural barriers still limit equitable listing access.

OPTN Policy Gave Back Time, Increased Transplants for Black Kidney Candidates So Why Have Rates Plateaued?

Michael E. Thase, MD, of the University of Pennsylvania

An interview with Thase explores rapid antidepressant effects and real-world considerations for single-day individualized GH001 dosing in TRD.


Psychiatry

Psychiatry condition center page is a comprehensive resource for clinical news and insights on mental illnesses. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for depression, schizophrenia, bipolar disorder, anxiety, and more.

Major Depressive Disorder

Major Depressive Disorder condition center page, resources on the topics of medical news and expert insight into depression can be found. Content includes articles, interviews, videos, podcasts, and breaking news on MDD research, treatment, and drug development.

Single-Day GH001 for TRD Shows Rapid Response, With Michael E. Thase, PhD

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.

Indirect data suggest oral semaglutide may reduce weight more than orforglipron, but cross-trial comparisons limit clinical interpretation.

Obesity Management

Obesity Management condition center page, resources on the topics of medical news and expert insight into clinical weight management can be found. Content includes articles, interviews, videos, podcasts, and breaking news on obesity research, treatment, and drug development.

Endocrinology

The HCPLive endocrinology page is a comprehensive resource for clinical news and insights on endocrine system conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for diabetes, hormonal disease, and more.

Indirect Analysis Suggests Greater Weight Loss With Oral Semaglutide vs Orforglipron

Ackerman offers a broad perspective on how psoriatic treatment is shifting, from oral IL-23 inhibitors to the emerging role of incretin therapy in psoriatic disease.

AAD 2026: Owning Psoriatic Disease, With Lindsay Ackerman, MD

Experts examine CSU endotypes and their implications for treatment selection and preview the emerging therapeutic pipeline including barzolvolimab and novel mast cell–depleting strategies.

Disease Mechanisms, Emerging Therapies, and Reducing Corticosteroid Reliance in CSU 

Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for HCPLive. He is also the executive producer of two podcasts: Skin of Color Savvy and The Medical Sisterhood. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

The durability of both skin clearance and itch reduction extended up to 4 years of lebrikizumab use in this assessment of adults and adolescents with atopic dermatitis.

Latest News

AAD 2026: 7 Late-Breaking Data Updates to Know in Dermatology

Obicetrapib is Safe and Well-Tolerated in HeFH and ASCVD, With Stephen Nicholls, MD

New VISIONARY Analyses Reinforce Benefits of APRIL Inhibition With Sibeprenlimab in IgAN

Key Takeaways on JAK Inhibitors and Black Box Warnings, With Eingun James Song, MD

6 Allergy Headlines You Missed in March 2026