Personalized medicine is expanding, but prior authorization remains a major obstacle.

Earlier recognition of type 2 inflammatory diseases could improve patient outcomes.

Understanding spontaneous remission may help shape future atopic dermatitis therapies.

 care is increasingly shifting toward a more personalized treatment paradigm, but several key barriers remain before those treating patients in dermatology can consistently match individuals with the medications most likely to benefit them, according to Jason Hawkes, MD, of the University of California, Davis.

Revolutionizing Atopic Dermatitis (RAD) Conference

, spoke about takeaways from his session, wherein he discussed the promise of precision medicine, the challenges posed by prior authorization, and data-related questions he believes will shape the next generation of eczema care.

Prior Authorization, Precision Medicine, and Eczema Remission, With Jason Hawkes, MD

How Personalized Medicine Is Changing Atopic Dermatitis Care

Hawkes explained that clinicians have long recognized recurring clinical patterns among patients with type 2 inflammatory disease, even before today's expanding medication landscape. Histories of childhood allergy, asthma, allergic rhinitis, and eczema often point toward shared inflammatory pathways. He described newer targeted therapies as allowing clinicians to better connect these characteristics with specific approaches to therapy.

Despite this progress, he noted that the healthcare system has not fully embraced individualized treatment. Step therapy requirements and prior authorization policies often require clinicians to prescribe medications based on formulary restrictions rather than selecting therapies they believe best fit a patient's clinical profile.

Hawkes suggested that while cost containment remains important, these policies can limit physicians' ability to practice personalized medicine and delay effective treatment for patients with chronic inflammatory skin diseases. He added that future research should focus on developing biomarkers or other objective measures that help clinicians identify the therapies most likely to succeed before treatment begins.

Why Earlier Recognition of Type 2 Diseases Remains Important

Hawkes also highlighted conditions he believes remain underrecognized despite increasing awareness. He pointed to chronic urticaria, mild asthma, hidradenitis suppurativa (HS), and atopic dermatitis itself, noting many patients continue to go undiagnosed or remain managed exclusively in primary care settings before reaching specialists. Earlier recognition of these interconnected type 2 inflammatory diseases could improve access to appropriate therapies as well as comprehensive care.

What Researchers Still Learn About Atopic Dermatitis

Looking ahead, Hawkes identified disease remission as one of the field's most important unanswered questions. He noted that some individuals naturally outgrow atopic dermatitis while others experience persistent disease into adulthood, yet the mechanisms underlying this difference remain poorly understood. Determining how the immune system achieves spontaneous remission could ultimately inform strategies aimed not only at controlling symptoms but also at inducing long-term remission or even preventing chronic disease altogether.

Disclosures: Hawkes has served as a consultant, advisory board member, investigator, and speaker for multiple pharmaceutical companies involved in dermatology, including AbbVie, Arcutis, Blueprint Medicines, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, Novartis, Regeneron, Sanofi, Sun Pharma, Takeda, and UCB, among others. He has also received research funding and reports stock ownership in Regeneron.

Hawkes J, Lieberman J. Session 2: Connecting AD to Other Dermatologic Disorders and Related Comorbidities. Session presented at: 2026 Revolutionizing Atopic Dermatitis Conference; June 17-19, 2026; Nashville, TN.

Hawkes J. How Are New Biologics Changing Atopic Dermatitis Treatment? HCPLive. July 22, 2026. 

https://www.hcplive.com/view/how-new-biologics-changing-atopic-dermatitis-treatment

Videos

Jason Hawkes, MD, highlights issues related to prior authorization as well as raising awareness of chronic urticaria, HS, atopic dermatitis, and other diseases.

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.

News

news page, resources on the topics of disease- and specialty-specific medical news and expert insight can be found. Content includes articles, interviews, videos, podcasts, and breaking news on health care research, treatment, and drug development.

Dermatology

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

Clinical

clinical page is a resource for content on every specialty, disease, and topic available on our medical news site.

Conference

 conference coverage page features articles, videos, and expert-led live coverage from major medical meetings throughout the year.

Philip Adamson, MD, MSc, is the chief medical officer of CVRx.

Alex Hajduczok, MD, is an advanced heart failure and pulmonary hypertension specialist at Oklahoma Heart Institute. 

Heart failure management has long been triggered by symptoms, yet the underlying neurohormonal cascade driving disease progression often begins well before congestion or breathlessness appear. Baroreflex activation therapy is drawing renewed attention as a way to intervene upstream, modulating the autonomic signaling the brain uses to interpret a failing heart as a circulatory emergency.

Moving the Needle in Medicine: Innovation, Leadership, and the Future of Heart Failure, With Philip Adamson, MD, MSc

, host Dr. Alex Hajduczok, MD, a cardiologist and heart failure specialist at Oklahoma Heart Institute, sits down with Dr. Philip Adamson, MD, MSc, chief medical officer of CVRx, to explore the personal experiences, mentors, and defining decisions that shaped his career in cardiovascular medicine.

Adamson traces his career from basic science and clinical investigation to device development and implementation science. Reflecting on his early research experiences, Adamson describes how an undergraduate laboratory project sparked a lifelong interest in scientific discovery while emphasizing the importance of intellectual curiosity, resilience, and remaining willing to challenge one’s own hypotheses throughout a research career.

Hajduczok and Adamson then examine the transformation of heart failure care over the past four decades, highlighting the shift from an era with limited therapeutic options to one defined by evidence-based, guideline-directed medical therapy. Adamson recounts the development of dedicated heart failure programs, the early skepticism surrounding subspecialization, and the growing recognition that multidisciplinary disease management is essential for improving long-term outcomes.

A major focus of the conversation centers on the development of implantable pulmonary artery pressure monitoring and the physiological principles underlying remote hemodynamic monitoring. Adamson reviews the lessons learned from early technologies that ultimately informed the creation of CardioMEMS, emphasizing that clinically useful monitoring must reflect meaningful pathophysiology, guide therapeutic intervention, assess treatment response, and provide sufficient lead time to prevent decompensation. Together, Hajduczok and Adamson also discuss implementation challenges, including clinician workflow, data management, and the emerging role of artificial intelligence and machine learning in transforming large volumes of physiologic data into actionable clinical insights.

The conversation also explores patient empowerment through remote monitoring technologies. Hajduczok and Adamson discuss how providing patients with actionable physiologic data may improve engagement, enhance self-management, and reduce heart failure hospitalizations by enabling earlier intervention before symptomatic congestion develops. They describe remote monitoring as an extension of chronic disease management, drawing parallels to continuous glucose monitoring in diabetes and emphasizing its potential to improve the scalability of care for increasingly complex heart failure populations.

Attention then shifts to autonomic modulation and baroreflex physiology, where Adamson reviews decades of work investigating baroreflex sensitivity as a predictor of cardiovascular outcomes and the rationale for neuromodulation therapies. He and Hajduczok discuss the evolution of Barostim therapy and its potential to influence multiple aspects of heart failure pathophysiology, including ventricular function, pulmonary pressures, autonomic balance, exercise capacity, and overall functional status. A recent patient experience serves to illustrate the systemic effects of neuromodulation, reinforcing the concept that heart failure requires therapies targeting interconnected physiologic networks rather than isolated mechanisms.

The episode concludes with reflections on scientific leadership, mentorship, and career development. Adamson encourages early-career investigators to embrace unexpected opportunities, learn from failure, maintain intellectual curiosity, and recognize that meaningful advances arise from continually questioning established knowledge. Together, Hajduczok and Adamson underscore that while research directions and professional roles evolve over time, a sustained commitment to improving the lives of patients with heart failure remains the driving force behind scientific innovation and clinical progress.

Editors’ Note: Hajduczok reports disclosures with CVRx, Edwards Lifesciences, and Impulse Dynamics. Adamson reports employment with CVRx.

Podcasts

Hear Philip Adamson, MD, MSc, discuss his path through heart failure and his work with Abbott and CVRx.

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...

Heart Failure

The HCPLive heart failure page is a resource for medical news and expert insights on HF. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for heart disease, reduced and preserved ejection fraction, and more.

podcasts page features a feed of medical news and interview podcast series, including DocTalk, Lungcast, Derm Discussions, and Heart Trials.

Moving the Needle in Medicine

Moving the Needle in Medicine is a monthly podcast from HCPLive Cardiology exploring the backstories and nuanced career paths that led the field’s movers and shakers to where they are today. Hosted by Alex Hajduczok, MD, the show will offer listeners insight into the biggest names in cardiology and beyond. 

This podcast is available via video on YouTube and on the HCPLive Cardiology podcast platforms on popular audio players.

Richard Lafayette, MD, is a professor of medicine and director of the Glomerular Disease Center at Stanford University Medical Center.

US Food and Drug Administration’s (FDA) 

accelerated approval of atacicept (Trutakna) for adults with primary

at risk for disease progression, Richard Lafayette, MD, FACP, discusses how BAFF/APRIL inhibition may reshape the treatment landscape for IgAN.

The approval was supported by data from the phase 3 ORIGIN 3 trial, in which atacicept reduced proteinuria by 42% compared with placebo at 36 weeks (

<.0001) and lowered galactose-deficient IgA1 (Gd-IgA1) levels by 68%. 

Q&A: Atacicept and Upstream Immune Targeting in IgAN With Richard Lafayette, MD

: Atacicept’s approval represents a major milestone in IgAN care. How do you see this therapy shaping the next era of disease management?

 I think this is really an amazing event. Patients now have access to a medication that can completely retarget their disease course and can actually give them the promise of not slowing, but completely preserving, their kidney function.

Of course, that data is yet to be seen from the phase 3 study, but the phase 3 study results showing very dramatic improvements in proteinuria, hematuria, and control of galactose-deficient IgA to a similar, if not better, degree than what we saw in the phase 2 trial gives us great optimism that this will really control their disease in a meaningful way and give them that chance of true preservation of kidney function.

: Atacicept targets both BAFF and APRIL, addressing key pathways involved in B-cell activation and IgAN pathogenesis. What does this approach reveal about our evolving understanding of the biology driving this disease?

 I think there is a lot of potential pushback about the four-hit hypothesis and the underlying tenets of that, including the role of mucosal immune dysregulation and genetic predisposition.

I think the fact that a BAFF plus APRIL inhibitor is being so effective at managing these biomarkers of IgA nephropathy really lends credence to this being a disease of B-cell misregulation or dysregulation, and that both BAFF and APRIL have key elements in controlling the disease.

Atacicept itself can be successful at managing BAFF and APRIL and, in turn, reducing the aberrant immune response that underlies IgA nephropathy.

: With the rapid expansion of disease-modifying therapies in IgAN, how should clinicians think about where atacicept fits within the broader treatment landscape?

 I think we have very clear goals from KDIGO and other treatment guidelines to get the patient’s disease activity under control rapidly and effectively.

So if patients are not already near goal where they can be simply managed with supportive therapy, atacicept really represents a true way forward that is targeted, effective, well tolerated, and really should be a tool that we reach for in the vast majority of patients who have the need for intervention.

 As clinicians begin incorporating atacicept into practice, which patients do you believe are most likely to derive the greatest benefit from this therapy?

I think any patient who is deemed at risk for progression. Again, those patients with more moderate disease can be stabilized with conservative therapy.

But any patient who fails reaching KDIGO guidelines of completely controlled proteinuria and no progression would be a fantastic candidate for atacicept, and hopefully will be treated in the near term.

: The ongoing ORIGIN 3 trial will eventually provide important insight into long-term kidney outcomes. What questions do you hope these data will answer about atacicept’s potential to alter the trajectory of IgAN?

 As I mentioned, we certainly have to wait for the GFR data for ORIGIN 3. Again, I’m confident that it will look similar to the phase 2b study, but seeing it is believing, and actually getting to that data will be really important.

We also hope it will shine light on the more long-term safety and tolerability of a once-weekly simple injection of atacicept, and that we’ll see, similar to the 9-month report, that the drug is well tolerated, that it’s safe, that it’s not associated with any excess infection, and most importantly, that the GFR truly is stable from baseline in patients who are experiencing these biomarker changes of improved proteinuria and hematuria.

: Is there anything else you would like to highlight about atacicept and its role in IgAN?

 Just to again go even deeper with the fact that this is the first real release of a drug that blocks both BAFF and APRIL, and that both cytokines have been legitimately linked to IgA nephropathy.

This really gives us the first opportunity to really control the source of the galactose-deficient IgA production and do it effectively.

Editor’s Note: Relevant disclosures for Lafayette include Aurinia, Callidatas, Complexa, Mallinckrodt, Omeros, Pfizer, Vera Therapeutics, and others.

Vera Therapeutics Receives FDA Accelerated Approval for TRUTAKNA™ for Adult Patients with Primary IgA Nephropathy.

Lafayette R, Barbour SJ, Brenner RM, et al. 

A Phase 3 Trial of Atacicept in Patients with IgA Nephropathy.

 N Engl J Med. Published online November 6, 2025. doi:10.1056/nejmoa2510198

Articles

FDA accelerated approval of atacicept for adults with primary IgA nephropathy at risk for progression introduces upstream BAFF/APRIL blockade as a disease-modifying strategy. In ORIGIN 3, atacicept achieved a 42% proteinuria reduction versus placebo at 36 weeks and a 68% decrease in galactose-deficient IgA1, with accompanying improvements in hematuria. Dual-cytokine inhibition supports a B-cell dysregulation model and offers a targeted, once-weekly injectable option. Definitive impact on eGFR preservation, long-term safety, and infection risk awaits mature phase 3 outcomes.

Richard Lafayette, MD, discusses how atacicept's FDA approval advances BAFF/APRIL targeting in IgA nephropathy.

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.

IgA Nephropathy

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.

FDA News

Atacicept and Upstream Immune Targeting in IgAN With Richard Lafayette, MD

Ann Marie Navar, MD, PhD, is an associate professor of cardiology at the University of Texas Southwestern Medical Center.

Ann Marie Navar, MD, PhD | Image Credit: UT Southwestern

On July 16, 2026, enlicitide (Lipfendra) received approval from the US Food and Drug Administration (FDA) to lower LDL-C in patients with hypercholesterolemia or heterozygous familial hypercholesterolemia (HeFH). The 20 mg tablet, administered once daily as an adjunct to diet and exercise, substantially reduced LDL-C in the CORALreef Lipids and CORALreef HeFH trials compared to placebo.

Now, with the drug expected to be accessible in a few weeks, parent company Merck will continue to investigate the drug’s safety and efficacy in lowering the risk of major adverse cardiovascular events through LDL-C lowering.

Ann Marie Navar, MD, PhD, associate professor of medicine in the Division of Cardiology at UT Southwestern Medical Center and a lead investigator throughout enlicitide’s investigational pathway, spoke with

 to discuss the drug’s potential impact on this condition, which affects a disproportionate percentage of the US population.


Q&A: Enlicitide’s FDA Approval for LDL-C Reduction and the CORALreef Outcomes Trial

How significant is this approval for preventive cardiology? Can it meaningfully change clinical practice?

I think this is really big. We now have an oral option that lowers LDL cholesterol by ≤60% on top of high intensity statins and other background therapies. That's huge in terms of getting more patients to goal. The approval, though, is just the first step. Now we actually have to get it into the hands of our clinician prescribers, and then ultimately into our patients. So, it's going to come down to: are people going to use it, and are we going to be able to get payers and insurers to cover it for the patients that need it?

What barriers did the field encounter with injectable PCSK9 inhibitors, and how might an oral version overcome them?

Well, some of the early barriers to uptake were the high sticker price, which led to really high copays and high rates of insurance company refusals, so we just couldn't get patients approved for the drug. That's actually gotten a lot better. The sticker price has come way down. The directed patient price for Repatha is <$250 a month, and a lot of PBMs have actually even dropped a prior authorization. So, approval rates are really high. The challenge is that not all of my colleagues are using them. We looked a couple of years ago, and 40% of cardiologists had never prescribed an injectable PCSK9. Over 90% of primary care doctors hadn't prescribed one. So, these drugs just haven't made it into the armamentarium of all of the clinicians that are seeing the patients who need further cholesterol lowering. This is where I'm hopeful for Lipfendra, enlicitide’s new brand name, that we'll be able to have more clinicians actually using this as an add-on after statins if people are not at LDL goal, and while the injections are really well tolerated and they work really well, I think it just takes a little bit more time to prescribe it in clinic than it does to prescribe a pill. And I think for some patients, it just sort of psychologically feels like a much bigger deal to add on a shot versus adding on a pill. I'm really hopeful that the availability of an oral PCSK9 actually broadens the number of people who are using these therapies. Maybe even use more injectables as well.

How do you interpret the 56-59% LDL-C reduction from CORALreef in the context of currently available lipid-lowering therapies?

Well, if you look at the LDL lowering, the non-HDL lowering, the ApoB, and the Lp(a) lowering, the efficacy of enlicitide looked almost identical numerically to what we saw with alirocumab and evolocumab. Now, all three of them have a little bit greater relative reductions in atherogenic lipoproteins than in glycerin, though even in glycerin is getting you well over 50%, so we know that inhibiting PCSK9 is a really powerful way to lower LDL cholesterol. This is just basically evolocumab or Repatha in a pill.

Which patients do you expect to benefit most from enlicitide initially?

Well, I would anticipate that probably the payers are going to make it easiest for us to get this drug for people with established ASCVD. That's certainly been the experience with the injectable PCSK9s, and that's also where we have cardiovascular outcomes data for at least the injectable class. So probably those with established ASCVD who are not reaching LDL goals, there's certainly a subgroup of patients, including those with FeFH, who just really do not want an injection and are waiting for more oral options, or on statin ezetimibe, and they're not at goal. I think this is going to be a great option for them now if they can get access to it to be able to increase their therapy and get to that goal of <55.

How do you weigh the convenience of oral medications against the adherence advantages of therapies administered every few months, like injectables?

Well, the CORALreef Lipids trial was a clinical trial, but it also was conducted in the real world. The participants in the trial lived their normal lives for a year, and we saw that the durability of the efficacy of enlicitide was sustained for the entire year that patients were on therapy. So, we've seen in thousands of patients that people are able to get on drug and stay on it. The administration requirements for Lipfendra are that you have to take it first thing in the morning on an empty stomach, but you can take it with your other medicines. So, you could take your statin and ezetimibe at the same time. I actually think for those patients, it was actually helpful to give them very explicit instructions on when to take it because we were able to make a habit out of it. People woke up, took their meds in the morning, and they continued on. And it really just is not that big of a deal. We also have had some data since then that a cup of black coffee or black tea does not affect the exposure to drug, so you can't eat food with it because that impacts the absorption. But if you're like me and don't want to talk to anybody without a cup of coffee, you can have a cup of black coffee before that 30 minute window is up.

What further questions are you hoping that the ongoing CORALreef Outcomes trial will answer?

Well, that trial is going to be really important to show us, you know, adherence data and LDL data for longer than a year. It will be also important to add to the continued body of evidence that lowers better not only in secondary prevention, but high-risk primary prevention. We saw data from the Vesalius trial recently that in high-risk individuals who have not had a prior cardiovascular event, PCSK9 inhibition, lowering LDL cholesterol well below 55, reduced cardiovascular events, and that was in people with high-risk diabetes or coronary calcium scores >100. CORALreef Outcomes is also including a high-risk primary prevention group, and so that's a group I'm really excited to continue to have more data on because I think the more evidence we have that lower is better in primary prevention, we'll be able to make even more aggressive recommendations to try to prevent the heart attacks before they happen, instead of waiting until they've already had an event to try to drive the cholesterol down.

Editors’ Note: This transcript has been edited for grammar and clarity using artificial intelligence tools.

Livingston R. Enlicitide Receives FDA Approval for Hypercholesterolemia Following CORALreef Trials. 

. July 17, 2026. Accessed July 22, 2026. 

https://www.hcplive.com/view/enlicitide-receives-fda-approval-for-hypercholesterolemia-following-coralreef-trials

Merck Clinical Trials. CORALreef Outcomes. Accessed July 22, 2026. 

https://www.merckclinicaltrials.com/trial/nct06008756/

FDA approval of oral enlicitide (Lipfendra) adds a once-daily PCSK9 inhibitor that reduced LDL-C ~56–59% in hypercholesterolemia and HeFH as adjunct to diet/exercise and background therapy. Efficacy across LDL-C, non–HDL-C, ApoB, and Lp(a) appears numerically comparable to alirocumab/evolocumab, potentially improving goal attainment, especially when injections are a barrier. Real‑world–conducted trial data suggest yearlong durability with fasting morning dosing. Access and payer coverage will likely determine uptake, while CORALreef Outcomes will test longer-term adherence and MACE reduction, including high-risk primary prevention.

Ann Marie Navar, MD, PhD, highlights enlicitide’s FDA approval for hypercholesterolemia and its potential to fundamentally change therapy.

Dyslipidemia

Enlicitide’s FDA Approval for LDL-C Reduction and the CORALreef Outcomes Trial

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.

Monopar Therapeutics Inc. has initiated the rolling submission of a New Drug Application (NDA) to the 

for ALXN1840 (bis-choline tetrathiomolybdate; TMC) in Wilson disease.

If approved, ALXN1840 would become the first FDA-approved Wilson disease therapy with a novel mechanism of action in decades. Current treatment options for Wilson disease have focused primarily on reducing copper accumulation through chelation or limiting intestinal copper absorption.

Wilson Disease Treatment Landscape Remains Focused on Copper Reduction

Wilson disease is a rare autosomal recessive disorder caused by pathogenic variants in the ATP7B gene, which impair biliary copper excretion and result in toxic copper accumulation in tissues, particularly the liver and brain. Patients may develop a range of manifestations, including liver disease and neurological or psychiatric symptoms such as personality changes, tremors, and difficulty with movement, swallowing, or speech.

Current FDA-approved therapies include copper chelators such as penicillamine and trientine, which increase urinary copper excretion, as well as zinc acetate, which reduces intestinal copper absorption.

“Wilson disease is a serious, lifelong condition, and patients and their families have waited a long time for a new treatment option,” said Chandler Robinson, MD, chief executive officer of Monopar, in a statement. “Initiating the rolling NDA submission marks an important milestone in our efforts to bring this novel copper-sequestering therapy to patients.”

ALXN1840 Designed to Promote Copper Mobilization

ALXN1840 (bis-choline tetrathiomolybdate) is an investigational once-daily oral therapy designed to bind and remove excess copper from tissues and blood through a novel mechanism of action. The therapy has received orphan drug designation from the FDA and orphan designation from the European Medicines Agency for Wilson disease.

The therapy is designed to address copper dysregulation by promoting copper mobilization and facilitating removal from the body. Unlike existing Wilson disease therapies that primarily rely on copper chelation or reducing absorption, ALXN1840 is intended to target copper stored in tissues and circulating in the blood.

Phase 3 FoCus Trial Supports NDA Submission

The regulatory submission is supported by findings from the pivotal phase 3 FoCus trial, a randomized, rater-blinded, multicenter study evaluating ALXN1840 compared with standard of care in patients with Wilson disease ≥ 12 years of age.

The trial enrolled 214 patients across 2 cohorts. The treatment-experienced cohort included patients who had received standard of care for more than 28 days, while the second cohort included patients who were treatment-naïve or had received standard of care for 28 days or less. Patients were randomized to receive ALXN1840 or standard of care.

The primary endpoint assessed copper mobilization over 48 weeks using the daily mean area under the effect curve (AUEC) for directly measured non-ceruloplasmin-bound copper (dNCC). ALXN1840 met the primary endpoint, demonstrating significantly greater copper mobilization compared with standard of care over 48 weeks.

According to Monopar, ALXN1840 demonstrated approximately three-times greater copper mobilization compared with standard of care (least squares mean difference, 2.18 µmol/L; 

 < .0001). Copper mobilization was observed within 4 weeks and sustained through the 48-week treatment period.

ALXN1840 Safety Profile Reported in Clinical Development Program

Across the ALXN1840 clinical development program, Monopar reported 645 patient-years of follow-up across 266 patients. In the FoCus trial, ALXN1840 was generally well tolerated, with most adverse events considered mild to moderate. The most frequently reported adverse event in the ALXN1840 treatment group was a reversible increase in transaminase levels.

The rolling NDA submission allows Monopar to submit completed sections of the application to the FDA for review as they become available. The FDA will determine whether the completed application is accepted for review following submission of all required components.

Monopar Therapeutics Inc. Monopar Initiates Rolling NDA Submission for ALXN1840 in Wilson Disease. GlobeNewswire News Room. Published July 22, 2026. Accessed July 22, 2026. 

https://www.globenewswire.com/news-release/2026/07/22/3331283/0/en/monopar-initiates-rolling-nda-submission-for-alxn1840-in-wilson-disease.html

ALXN1840.; 2025. Accessed July 22, 2026. 

https://www.monopartx.com/pipeline/alxn1840

Monopar Therapeutics has begun a rolling NDA submission to the FDA for ALXN1840 (bis-choline tetrathiomolybdate) for Wilson disease, positioning it as a potential first-in-decades therapy with a distinct copper-sequestering mechanism. Wilson disease results from ATP7B variants causing impaired biliary copper excretion with hepatic and neuropsychiatric toxicity. In the phase 3 FoCus trial (n=214; ≥12 years), ALXN1840 achieved significantly greater copper mobilization versus standard of care over 48 weeks, with early onset and durability. Safety was generally favorable; reversible transaminase elevations were most common.

Monopar initiated a rolling NDA submission for ALXN1840, an investigational therapy for Wilson disease targeting copper dysregulation.

Hepatology

Neurology

Neurology condition center page is a comprehensive resource for clinical news and insights on nervous system disorders. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for Alzheimer's disease, brain injury, PTSD, and more.

Monopar Files Rolling NDA for ALXN1840 in Wilson Disease

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.

Experts unpack where new eczema creams fit, and why insurance hurdles and steroid fear keep patients from faster itch relief.

New Topicals in Atopic Dermatitis: Evidence, Barriers, and Real-World Perspectives 

Jason Hawkes, MD, explains how targeted therapies are advancing precision medicine and reshaping personalized care for atopic dermatitis.

How Are New Biologics Changing Atopic Dermatitis Treatment?

Phase 2 data suggest zabopegdutide improved liver fat, stiffness, and fibrosis biomarkers within 12 weeks in adults with MASH.

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.

Phase 2 Data Show Early Liver Benefits With Zabopegdutide in MASH

Linda Stein Gold, MD, is a dermatologist at Henry Ford Health. 

Most newer nonsteroidal topical options are now approved for children as young as 2 years. Linda Stein Gold, MD, discusses adherence and misconceptions of pediatric AD.

Treatment Selection, Adherence, and Misconceptions in Pediatric Atopic Dermatitis

Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

If approved, encaleret will be the first treatment specifically indicated for this underrepresented patient population.

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.

This page also hosts content previously published by EndocrinologyNetwork. 


Hormonal Disorders

FDA Accepts NDA for Encaleret for Autosomal Dominant Hypocalcemia Type 1

Abigail Brooks is a strategic content lead overseeing 

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.

Plozasiran cut triglycerides up to 81% and reduced acute pancreatitis events in phase 3 SHASTA-3, SHASTA-4 trials for severe hypertriglyceridemia.

Plozasiran Meets Primary Endpoint in SHASTA-3, SHASTA-4 sHTG Trials

In the final episode of the series, the discussion turns to therapies currently in development for CSU.

Video Series

Emerging Therapies on the Horizon for CSU

In this episode titled “Building Therapeutic Alliance and Addressing Access Barriers in CSU,” the panel focuses on practical strategies for empowering both patients and clinicians earlier in the CSU care journey.

Building Therapeutic Alliance and Addressing Access Barriers in CSU

This Q&A highlights the significance of the FDA approval of risankizumab (Skyrizi) for psoriasis and psoriatic arthritis in pediatric patients.

Plaque Psoriasis

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.

Q&A: How Is Risankizumab’s FDA Approval Changing the Psoriatic Disease Landscape?

New topical mechanisms introduce more ways to control pediatric AD without the sting, burn, or long-term steroid concerns that limit adherence, Linda Stein Gold, MD, says.

Latest News

Prior Authorization, Precision Medicine, and Eczema Remission, With Jason Hawkes, MD

Moving the Needle in Medicine: Innovation, Leadership, and the Future of Heart Failure, With Philip Adamson, MD, MSc

Atacicept and Upstream Immune Targeting in IgAN With Richard Lafayette, MD

Enlicitide’s FDA Approval for LDL-C Reduction and the CORALreef Outcomes Trial

Monopar Files Rolling NDA for ALXN1840 in Wilson Disease