Andrew Adams MD, PhD, is Professor of Surgery and Chief of the Division of Transplantation at the University of Minnesota

Tegoprubart Sustains Higher eGFR Than Tacrolimus Long-Term

Tegoprubart Sustains Increased Longterm eGFR Compared to Tacrolimus

Long-term follow-up from the phase 2 BESTOW extension study found that kidney transplant recipients treated with tegoprubart maintained increased estimated glomerular filtration rate (eGFR) compared with those receiving tacrolimus, with the difference remaining statistically significant at 18 months.

The findings, presented at the American Transplant Congress 2026, provide additional follow-up on whether CD154-directed immunomodulation with tegoprubart may offer a strategy to reduce reliance on calcineurin inhibitor-based regimens, which remain the standard of care in kidney transplantation but are associated with long-term toxicities, including nephrotoxicity.

For transplant clinicians, the ongoing challenge is balancing effective rejection prevention with preservation of kidney function over the lifetime of the graft. Tacrolimus remains highly effective at preventing rejection, but cumulative exposure has been associated with complications including calcineurin inhibitor nephrotoxicity, metabolic effects, and other adverse events.

“Even the best of kidneys over time tend to have damage and scar formation,” said Andrew Adams, MD, PhD, professor of surgery and chief of the division of transplantation at the University of Minnesota. “Some of that traces directly to the immunosuppressive therapy itself.”

Tegoprubart is an investigational monoclonal antibody targeting CD154 (CD40 ligand), a pathway involved in T-cell activation and immune responses that contribute to organ rejection.

“Interrupting that pathway with an antibody like tegoprubart can prolong survival, and it does so in a very specific way so that we don't see the side effects that traditional immunosuppression tends to bring along,” Adams said.

Among patients who completed 12 months of treatment in BESTOW, 96% of tegoprubart-treated patients and 86% of tacrolimus-treated patients entered the long-term extension study. Mean follow-up reached 21 months, including 89 patients followed through 18 months.

Kidney function, measured by eGFR, remained higher among tegoprubart-treated patients at each reported time point. At month 18, mean eGFR was 74 mL/min/1.73 m² with tegoprubart compared with 61 mL/min/1.73 m² with tacrolimus (

Biopsy-proven acute rejection (BPAR) events after 6 months were not observed among tegoprubart-treated patients, compared with 7 events (9.4%) among patients receiving tacrolimus. Among patients who experienced rejection, those who remained on tegoprubart had higher observed mean eGFR compared with tacrolimus-treated patients, with the difference increasing from approximately 15 mL/min/1.73 m² at 12 months to approximately 25 mL/min/1.73 m² at 21 months in an exploratory analysis.

Patient-reported outcomes also favored tegoprubart at 52 weeks. Tegoprubart-treated patients reported lower symptom burden on the Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD-59R) and higher scores on the KDQOL-36 Symptoms and Problems domain compared with tacrolimus-treated patients.

During long-term follow-up, several adverse events occurred less frequently in the tegoprubart group compared with the tacrolimus group, including headache, extremity pain, falls or loss of balance, acute kidney injury, and diarrhea.

No graft loss, progressive multifocal leukoencephalopathy, post-transplant lymphoproliferative disorder, BK or CMV nephropathy/disease, or new malignancies were reported in the tegoprubart cohort. One death occurred in the tegoprubart arm and was not attributed to study treatment.

Following an FDA End-of-Phase 2 meeting, Eledon Pharmaceuticals plans to initiate a phase 3 kidney transplant program in late 2026. The planned phase 3 study will evaluate non-inferiority versus tacrolimus at 52 weeks using a composite endpoint of biopsy-proven acute rejection, graft loss, and death.

Although the BESTOW extension data represent the longest reported follow-up for tegoprubart in kidney transplantation to date, larger phase 3 studies will be needed to determine whether the observed eGFR advantage translates into improved long-term transplant outcomes.

Editor’s Note: Adam’s reports relevant disclosures Eledon Pharmaceuticals, Miromatrix, and Sanofi.

Eledon Pharmaceuticals, Inc. Eledon presents long-term extension phase 2 BESTOW results at American Transplant Congress showing sustained higher kidney function and improved patient-reported outcomes with tegoprubart compared with tacrolimus. News release. GlobeNewswire. June 22, 2026. Accessed July 10, 2026. 

https://www.globenewswire.com/news-release/2026/06/22/3315172/0/en/eledon-presents-long-term-extension-phase-2-bestow-results-at-american-transplant-congress-showing-sustained-higher-kidney-function-and-improved-patient-reported-outcomes-with-tego.html

Kidney Disease: Improving Global Outcomes (KDIGO) Transplant Work Group. KDIGO clinical practice guideline for the care of kidney transplant recipients. 

Videos

Andrew Adams, MD, PhD, discusses Bestow Phase 2 data in tegoprubart compared to tacrolimus. 

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Chronic Kidney Disease

Tegoprubart Sustains Increased eGFR Longterm Compared to Tacrolimus

Parag Joshi, MD, is an assistant professor of medicine at UT Southwestern Medical Center and an adjunct assistant professor of medicine at Johns Hopkins School of Medicine.

Beyond Atherosclerosis: Coronary Calcium Scoring in Dyslipidemia, CKM Syndrome

Coronary calcium (CAC) scoring has experienced a resurgence after the official classification of cardio-kidney-metabolic (CKM) syndrome, with new guidelines supporting its use in 

In a presentation at the American Society for Preventive Cardiology (ASPC) 2026 Virtual Imaging Symposium, Parag Joshi, MD, assistant professor of medicine at UT Southwestern Medical Center and adjunct assistant professor of medicine at Johns Hopkins School of Medicine, discusses the inherent value of CAC scoring in disease states beyond 

atherosclerotic cardiovascular disease (ASCVD)

“Plaque can form regardless of your cholesterol numbers for the most part; what is normal for a given individual may be very different than what is sort of low for a population,” Joshi told 

 in an exclusive interview. “What we think of as normal cholesterol may still be enough to develop significant amounts of plaque. While it’s more likely that people with higher cholesterol will develop plaque, and people with lower cholesterol will be somewhat protected from that, it’s not 100%.”

CAC scoring is among the most thoroughly studied and widely available tests in cardiology. The process involves a computerized tomography (CT) scan of the heart, examining patients for calcium deposits in the arteries. Modern scans take roughly 10-15 minutes and roughly 1 mSy of radiation without the need for contrast agents.

The 2026 Guideline on the Management of Dyslipidemia, released by the American College of Cardiology (ACC) and American Heart Association (AHA) Joint Committee on March 13, 2026, notes that CAC testing can potentially identify patients without CAC who are less likely to benefit from statin therapy for ASCVD, as well as identify those who are at risk without known ASCVD.

The guideline also heavily emphasizes the value of CAC beyond solely atherosclerosis. The document recommends CAC scoring in men ≥40 years and women ≥45 years to provide guidance for LDL-C and non-HDL-C goals. Moreover, in patients resistant to implementing or reinitiating further lipid-lowering therapy or statins, CAC scoring is suggested as an option to support the need, or lack thereof, for further medication.

Joshi also addresses the potential risks of CT scanning for CAC, particularly the need for radiation exposure. He posits that the impact of the radiation is not yet fully understood and that only time will tell if the value is worth the risk. Additionally, he mentions ongoing investigations into further advancements in CT scanning to optimize CAC while minimizing radiation exposure.

“Are the trade-offs worth it? What I mean is, is radiation exposure worth getting the more advanced test over just a simpler test like a calcium score?” Joshi said. “I think time will tell what the answer to that will be. There are companies that have platforms for AI evaluation of CT angiogram-based plaque, and some of those companies are doing trials to see how that will impact outcomes compared to usual care and repeating a CT angiogram to see how plaque progresses on a certain treatment regimen.”

Editors’ Note: Joshi reports disclosures with Novo Nordisk, Amgen, Kaneka, Novartis, and Eli Lilly.

Joshi P. CAC in Cardiometabolic Risk: Diabetes, CKD, Women, and “The Paradox of Normal LDL-C”. Presented at the American Society for Preventive Cardiology (ASPC) 2026 Virtual Imaging Symposium. April 25, 2026.

Greenland P, Blaha MJ, Budoff MJ, Erbel R, Watson KE. Coronary Calcium Score and Cardiovascular Risk. J Am Coll Cardiol. 2018;72(4):434-447. 

Blumenthal RS, Morris PB, Gaudino M, et al. 2026 ACC/AHA/AACVPR/ABC/ACPM/ADA/AGS/APHA/ASPC/NLA/PCNA guideline on the management of dyslipidemia: A report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2026;153(17). 

Parag Joshi, MD, highlights CAC scoring’s value as a prognostic tool for lipid-lowering therapy.

Cardiology

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Dyslipidemia

Atherosclerotic Cardiovascular Disease

Davinder Parsad, MD, serves as a professor for the Department of Dermatology at the Postgraduate Institute of Medical Education & Research (PGIMER) in Chandigarh, India.

On June 25, 2026, a new World Vitiligo Day took place, allowing new opportunities for those in the dermatology field to advocate for and empower patients living with 

 Vitiligo, an acquired autoimmune depigmenting condition known to impact approximately 0.36% of the population around the world, is 1 of the most visible skin conditions and can strongly affect patients’ well-being and quality of life.

This awareness day is designed to potentially impact legal frameworks as well as draw in pharmaceutical investment. In India, Davinder Parsad, MD, a professor in the Department of Dermatology at the Postgraduate Institute of Medical Education & Research (PGIMER) in Chandigarh, successfully unified 3 national dermatological societies to endorse World Vitiligo Day.

 editorial team following World Vitiligo Day, highlighting the importance of the awareness day, upcoming therapies in the vitiligo treatment space, and continuing misconceptions the public has about the disorder:

World Vitiligo Day and Vitiligo Awareness Month have both concluded recently. From your perspective, what would you say is the impact of these awareness days and months on actual clinical practice? Have you noticed any changes in patient engagement?

Yeah, as you rightly pointed out, when we organized World Vitiligo Day, when it started, the focus was on a single day. This year, we thought, why not have a long-term, ongoing process rather than just a single day of organization like World Health Day. And yes, probably with the education given through this platform to the patient, it has helped to an extent. But I think we have to go a long way to involve patients in every aspect of the treatment, and to improve their quality of life. It should be an ongoing process, which has to be focused on daily basis rather than just one day per year.

 Despite the growing awareness you mentioned, what would you say are the biggest misconceptions about vitiligo among patients, or even among healthcare providers?

I would say it varies from region to region. Here in our part of the world, India, we have many stigmas, many myths concerning this disease. We are educating our patients on that as well, and some…consider it a cosmetic disease. So they say the treatment is optional, but that is not a correct message. Because we have to treat this disease early, and in some cases, maybe aggressively to control the disease activity, that message has just not been fully implemented.

We are in an era now where repigmentation is an actual attainable treatment goal for many patients. How would you say the availability of targeted therapies has changed conversations with patients?

Yes, over the last few years, with the first FDA approval for repigmentation therapy, that is ruxolitinib ointment. It has sort of opened a hope for vitiligo patients. The targeted treatment can be used in the near future in the management of vitiligo. We have also, in our daily practice, started with broad-spectrum immunosuppressives like oral mini-pulse and other broad-spectrum immunosuppressive agents. But now, with this pathomechanism of the JAK-STAT pathway, which is emerging as one of the best models to tackle vitiligo, we are very hopeful that we are moving towards a targeted treatment with the JAK inhibitors and other such therapies, which can target that pathway.

Which clinical data or potential regulatory milestones are you looking at most closely in the vitiligo space?

As of now, we have just one topical approved as a repigmentation therapy in vitiligo, but I understand the phase 3 results of new JAK inhibitors like upadcitinib, ritlecitinib, and povorcitinib are encouraging. Probably, that will be in the pipeline for approval in the management of vitiligo, and for controlling the disease activity, we need a systemic approach with these targeted molecules.

Beyond efficacy, what would you say are any unanswered questions that remain for clinicians?

 This is a very important point because of the durability of repigmentation with the currently available JAKs. We probably need a long-term treatment because, especially in non-segmental vitiligo, it's a dynamic process. To achieve total stability of the treatment is still is a is a dream as of now for the management of vitiligo. We have to give maintenance therapy in the form of topical agents like topical calcineurin inhibitors, or a long-term therapy with a safe molecule which we can continue for a long period of time. Then probably intermittent therapy, which can be given for a longer duration.

What are you most looking forward to for next year’s World Vitiligo Day?

We are still, I think, lagging behind in stabilization and repigmentation. So we have good molecules now, JAK inhibitors and other molecules in the pipelines, but we need to focus on the repigmentation strategies. Some newer molecules can make the melanocyte proliferate faster, then migrate to give rise to better repigmentation. So, as of now, phototherapy is the gold standard, because the majority of this treatment they are dependent on a combination with phototherapy. Probably we need to look into that term of repigmentation strategies, and we have to focus on the next 4 to 5 years.

Regarding the World Vitiligo Day, we just want to keep focus on awareness and educating about vitiligo subjects and the population at large. This is a treatable condition, so one needs to start an early treatment because vitiligo is a disease which is differs from other autoimmune diseases in a sense. Here we are relying on the reservoir, so if we don't have a reservoir of melanocytes, which tend to get depleted with the long-term duration of vitiligo, it's very difficult to repigment. Just to save this reservoir, we need to start the treatment early, and that is the message we want to disseminate, as early treatment is one of the best approaches for successful treatment.

Disclosures: Parsad reported no relevant financial disclosures.

Valle Y, Parsad D, Sigova J, et al. World vitiligo day: a model for grassroots medical activism and pharmaceutical innovation. Front Med (Lausanne). 2025 Apr 15;12:1571422. 

Seneschal J, Bae JM, Picardo M, et al. Vitiligo. Nat Rev Dis Primers. 2025 Dec 4;11(1):85. 

Mendonça CR, Mohamed A, Torres T, et al. New and emerging treatments for vitiligo: a narrative review. Expert Rev Clin Pharmacol. 2026 Jan-Feb;19(2):117-132. 

Articles

World Vitiligo Day is positioned as an ongoing platform for patient education, stigma reduction, and policy and investment engagement, with particular momentum in India through coordinated dermatology-society advocacy. Vitiligo remains highly visible and quality-of-life limiting, and misconceptions—especially framing it as merely cosmetic—delay appropriate care. Targeted therapy has shifted expectations, with topical ruxolitinib establishing repigmentation as attainable and multiple systemic JAK inhibitors showing encouraging phase 3 signals. Key unmet needs include durable repigmentation, long-term maintenance strategies, and earlier intervention to preserve melanocyte reservoirs.

In this Q&A interview, Davinder Parsad, MD, highlights vitiligo misconceptions and upcoming news in the vitiligo treatment pipeline.

Dermatology

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Vitiligo condition center page is a comprehensive resource for clinical news and insights on the dermatologic condition. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for the affected skin of vitiligo patients.

Q&A: Where is Vitiligo Headed in 2026? With Davinder Parsad, MD

Hilary Baldwin, MD, medical director of the Acne Treatment & Research Center at Atlantic Health and associate professor of dermatology at SUNY Downstate Medical Center. 

 affects millions of adults, yet it remains one of the most misunderstood conditions in dermatology.

 Many patients believe their symptoms are caused by alcohol use or are simply untreatable, misconceptions that can delay diagnosis and rosacea treatment for years.

Diagnosis is often complicated further by overlapping rosacea subtypes and presentations that mimic or coexist with acne, making an accurate read of the skin essential before starting therapy.

 Hilary Baldwin, MD, medical director of the Acne Treatment & Research Center at Atlantic Health, addressed the persistent stigma around rosacea, the current rosacea treatment pipeline and her approach to patients presenting with more than one rosacea subtype simultaneously. This interview follows Baldwin’s “Acne and Rosacea Update 2026” presentation at Maui Derm NP+PA Summer 2026 in Colorado Springs.

The Stigma Behind Rosacea: Separating Fact From Misconception

 Are there persistent misconceptions around rosacea?

 The outside world looks at somebody with an enlarged red nose, especially if it has telangiectasias on it, and [immediately assume] that the person is consuming too much alcohol. It's called a “whiskey nose”—a “rum blossom” in the past—and this is simply not true. That is an assumption that everybody makes when they see patients with rhinophymatous noses, or red noses.

One of the other misconceptions of the patient is that there's no treatment. I have patients come in all the time for other issues with a red face or [with] papules [on their] face as an adult, and [when] I [point it] out, [they say], “Oh, I didn't know that could be treated,” or “I've always looked like this,” or “my sister looks like this and so does my mother.”

That doesn't necessarily mean you don't want treatment. It's incumbent upon us to mention the findings of rosacea in patients who come in for other reasons and don't specifically ask about their rosacea because they simply don't know that there are excellent treatments out there.

A Quiet Pipeline: Where Rosacea Treatment Development Stands Today

What's currently in the pipeline for rosacea?

 I don't think there is anything. I am unaware of anything in the pipeline.

How do you help clinicians decide which treatment to reach for in a patient presenting with multiple rosacea subtypes at once?

 Most of our rosacea patients do not fit neatly into a category of erythematotelangiectatic, papulopustular, phymatous, or ocular. They have a little bit of everything, or more than 1 component.

Unfortunately, the treatments that we have treat only 1 aspect of rosacea, so when patients have combination rosacea, they're going to need at least 2 medications, sometimes 2 medications [and] a procedure.

What I like to do is hand them a mirror [and] have them look at themselves while I point out the salient features of their disease. Your eyes are a little bit red when you wake up in the morning, or your eyes [are] dry. You have gunk in the corner of your eye that you need to clean out. Notice this little redness on your cheeks. You've got a couple pimples over here; you've got some…broken blood vessels, or telangiectasias on [your] nose.

I point out all the features, and then I say, ‘Okay, so this is what you've got. What do you care about?’ This is a crucial question. You would be amazed at what doesn't bother people and what does.

I've had people come in with a bright red face, stop sign red, not even realizing that they have a red face. Sometimes that doesn't bother them, and you can't assume what would bother you on your face…bothers them. Additionally, there might be 1 thing that can be treated with pharmacologic treatment with a co-pay, and another 1 that's going to require a procedure and out-of-pocket expense. So, I [ask] them first: Which of all these things that I just showed you do you care about the most? 

It's very important to get the patient buy-in and make sure that they understand all the little aspects of this because it's a chronic disease. It's going to require chronic treatment, so they really need to be a part of the decision-making process.

Rosacea or Acne? Key Clinical Clues for Adult Patients

 Acne and rosacea can overlap or can be confused in adult patients. What clinical features help you separate the 2 when a patient presents with the mixed picture?

 Acne and rosacea have a lot of features in common. One of our first jobs is to determine which disease they have.

Let's start with age. An acne patient is more likely to be younger, and a rosacea patient more likely to be older. Of course, many women go on to have adult acne, so that's not always the most important feature. The most important to me is the presence or absence of comedones.

If you see comedones, it is acne. Period. It is not rosacea. If there's no comedones, it could be either one. Hyperpigmentation and scarring really does not occur in rosacea; a papule comes and goes and generally leaves no mark behind, except maybe a little erythema.

Of course, [the patient] could have rosacea now [but] had acne as a child, so they have some scarring from that. But if the lesions that they get are creating scars, it is acne.

Background erythema [is] a hallmark of rosacea. In acne, there is no such thing. The pimples are red, but the normal skin surrounding the pimple is usually not red. Acne can be on the chest and back as well, and rosacea is generally not.

Rosacea is usually the center of the face. Acne can be the center of the face as well, but when it is, it's mostly comedones, and that would not be seen in rosacea.

The size of the pimples matter. When you see big, juicy red papules…that's mostly acne. Rosacea papules, although quite red, tend to be smaller than acne papules.

If a clinician can only change one habit in their acne or rosacea management this year, what would it be?

 Consistent use of the medications that we recommend.

I think the patients don't realize when we come up with a relatively complicated regimen, perhaps 2 topicals, or a topical and a pill, that there's a reason for each of the ingredients that we have recommended to them. [Patients] tend to stop something, and…[say], “That wasn't working.” How do you know? You were using 2 things, and you stopped 1.

Compliance is important, but ultimately, I think the fault comes back to us. If the patient doesn't recognize the importance of multiple steps in their regimen, [it] is because we [failed] to educate them adequately [on] why we're forcing them to use more than 1 thing. It's not a plot to make them miserable. There's a rational reason for the combination therapies. Patient education is paramount, and [it is] often not done quite as well as we could.

Watch the interview with Baldwin as she uses a single hypothetical patient to illustrate how 

Editor’s note: Reported disclosures for Baldwin include Galderma Laboratories, L.P, Ortho Dermatologics, a division of Bausch Health US, LLC, SUN PHARMACEUTICAL INDUSTRIES INC., LNHC, Inc, GENZYME CORPORATION, Journey Medical Corporation, and Novartis Pharmaceuticals Corporation.

Rosacea Prevalence. National Rosacea Society. Accessed July 10, 2026. 

https://www.rosacea.org/press/prevalence-map

Baldwin H. Acne and Rosacea Update 2026. Session presented at the Maui Derm NP+PA Summer 2026 meeting in Colorado Springs.

In this Q&A, Hilary Baldwin, MD, discusses common misperceptions, the current pipeline, and how she separates rosacea from acne.

Conference

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The Rosacea Misconception Clinicians Still Hear Every Day

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 New Drug Application (NDA) for deucrictibant for on-demand treatment of hereditary angioedema (HAE) attacks and supplemental NDAs (sNDA) for mitapivat in 

 and roflumilast cream 0.05% (Zoryve) for infants aged 3 months to younger than 24 months living with 

, as well as the accelerated approval of atacicept (Trutakna) to reduce proteinuria in adults with primary 

 at risk for disease progression. Compass Pathways additionally reported 6-month data from the phase 3 COMP006 trial showing the benefit of 2 fixed doses of COMP360 in 

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 July 5, 2026 — let's jump in!

FDA Accepts NDA for Oral Deucrictibant for HAE Attacks

On July 6, 2026, the FDA accepted Pharvaris' NDA for deucrictibant immediate-release (IR) capsules, an oral bradykinin B2 receptor antagonist intended for on-demand treatment of HAE attacks, with a Prescription Drug User Fee Act (PDUFA) target action date of April 23, 2027. If approved, deucrictibant IR would become the first oral agent in its drug class for acute HAE attack treatment.

FDA Grants Priority Review to Agios’ Mitapivat sNDA for Sickle Cell Disease

On July 7, 2026, the FDA accepted Agios Pharmaceuticals’ supplemental New Drug Application (sNDA) for mitapivat in sickle cell disease and granted the application Priority Review, along with assigning a Prescription Drug User Fee Act (PDUFA) goal date of November 1, 2026.

If approved, mitapivat would become the first oral pyruvate kinase (PK) activator for patients with sickle cell disease, providing a potential new treatment approach for a population with significant unmet medical needs.

FDA Approves Atacicept (Trutakna) for IgA Nephropathy

On July 7, 2026, the FDA granted accelerated approval to atacicept (Trutakna) to reduce proteinuria in adults with primary IgAN at risk for disease progression, offering patients an autoinjector for at-home self-administration of a once-weekly subcutaneous injection.

The decision was supported by data from a prespecified interim analysis of the ORIGIN 3 trial, where participants treated with atacicept achieved a 46% reduction from baseline in proteinuria, with a statistically significant and clinically meaningful 42% reduction compared to placebo (

COMP360 Psilocybin Sustains Depression Benefit Through 26 Weeks

On July 7, 2026, Compass Pathways reported 6-month data from the phase 3 COMP006 trial trial showing 2 fixed doses of COMP360, an investigational synthetic psilocybin formulation, produced a reduction in depressive symptoms that was maintained through 26 weeks in more than a third of participants with treatment-resistant depression.

FDA Accepts sNDA for Roflumilast Cream 0.05% in Infants Down to 3 Months with Eczema

On July 8, 2026, the FDA accepted a supplemental New Drug Application (sNDA) from Arcutis Biotherapeutics for the expansion of the indication for topical roflumilast cream 0.05% (Zoryve) to include infants aged 3 months to younger than 24 months living with mild to moderate atopic dermatitis. The Agency has assigned the medication a Prescription Drug User Fee Act (PDUFA) target action date of February 23, 2027. 

If approved, the expanded indication for roflumilast cream 0.05% would make it the first once-daily, nonsteroidal, targeted topical option specifically indicated for atopic dermatitis in this younger age bracket. Currently, the drug is approved for children in the 2 - 5 year range with mild to moderate disease.

Multiple FDA actions this week signal momentum across rare disease, hematology, nephrology, dermatology, and neuropsychiatry. Pharvaris’ oral bradykinin B2 antagonist deucrictibant for on-demand hereditary angioedema attacks received NDA acceptance with an April 2027 PDUFA date. Agios’ mitapivat sNDA in sickle cell disease secured Priority Review and a November 2026 PDUFA. Accelerated approval was granted to atacicept for primary IgA nephropathy proteinuria reduction. Six‑month phase 3 data supported durable COMP360 benefit in treatment‑resistant depression, and roflumilast cream’s infant atopic dermatitis sNDA was accepted.

This week’s headlines include the FDA acceptance of mitapivat and roflumilast applications, the approval of atacicept for IgA nephropathy, and more.

Allergy

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The HCPFive: Top News for Healthcare Providers from the Week of 07/05

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.

New phase 2 findings on tralokinumab, from TRAPEDS-1, show favorable results in children 6 - 11 years with atopic dermatitis.

Atopic Dermatitis

Atopic Dermatitis 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 dermatitis research, treatment, and drug development.

TRAPEDS-1: Tralokinumab Effective, Safe in Children With Atopic Dermatitis

Piotr Witkowski, MD, PhD, is a professor of surgery in the Transplantation Institute at the University of Chicago.

Piotr Witkowski, MD, PhD, discusses the CD40L inhibitor’s efficacy in improving outcomes for patients with T1D undergoing islet transplant.

Endocrinology

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This page also hosts content previously published by EndocrinologyNetwork. 


Type 1 Diabetes

All 12 Tegoprubart Recipients Off External Insulin Following Islet Implant in Pilot Study

Patricia de Sequera, MD, PhD, chief of nephrology at University Hospital Infanta Leonor in Madrid

MOTheR trial data suggest expanded hemodialysis offers comparable outcomes to online hemodiafiltration for dialysis patients, Patricia de Sequera, MD, PhD explains. 

Expanded Hemodialysis Offers Alternative to Online Hemodiafiltration

Justin Gregory, MD, MS, is the field medical director for autoimmune T1D at Sanofi.

Justin Gregory, MD, MPH, and Steve Zortman, MPH, RN, discuss the critical need for early detection and intervention in this underrepresented population.

Screening for Type 1 Diabetes in Adults: What Needs to Change

At Maui Derm NP+PA Summer 2026, Benjamin Ungar, MD, discussed early clues for scarring alopecia, pipeline JAK inhibitors, and setting patient expectations.

Alopecia

Early Signs of Scarring Alopecia, Pipeline Outlook, With Bejamin Ungar, MD

An expert explains why long-acting growth hormone analogs represent more than a convenience upgrade, emphasizing adherence, treatment burden, and future directions in individualized dosing.


Video Series

Long-Acting Growth Hormone Analogs: Beyond Convenience to Individualized Care

An expert discusses how clinicians can apply registry data alongside randomized trial evidence to address long-term safety, persistence, and real-world outcomes in growth hormone therapy.


Leveraging Growth Hormone Registries to Inform Long-Term Treatment Decisions


An expert compares insights from historical and contemporary growth hormone registries with randomized trial data, highlighting their complementary roles in evaluating long-acting GH analogs.


Real-World Registries vs Clinical Trials in Long-Acting Growth Hormone Therapy

Stevan Gonzalez, MD, MS, is the Director of Liver Transplantation at Baylor Scott and White All Saints Medical Center in Fort Worth, Texas. 

Earlier diagnosis is imperative for chronic liver disease; Stevan Gonzalez, MD, MS, explains how PCPs and community-based screening programs can help. 

Hepatology

MASH / MASLD

The HCPLive MASH & MASLD page is a comprehensive resource for clinical news and insights on metabolic dysfunction-associated steatotic liver disease and steatohepatitis. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for fatty liver disease, steatohepatitis, and more.

Strategic Alliance Partnership

Chronic Liver Disease: How PCPs Can Improve Early Detection 

An expert reviews key considerations for IGF-1 monitoring, timing of blood draws, and dose individualization when transitioning patients from daily growth hormone to long-acting analogs.

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The Rosacea Misconception Clinicians Still Hear Every Day

The HCPFive: Top News for Healthcare Providers from the Week of 07/05