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.

Omalizumab demonstrated superior efficacy to multiallergen oral immunotherapy (MOIT) for 

 in the intention-to-treat analysis of the OUTMATCH stage 2 randomized clinical trial. However, the advantage narrowed once accounting for treatment discontinuation.¹

Omalizumab (Xolair) received US Food & Drug Administration (FDA) approval in 2024 for reducing allergic reactions, including anaphylaxis, following accidental food exposure, and remains 1 of only 2 approved food allergy therapies alongside a peanut oral immunotherapy (OIT) product: Palforzia, which will be permanently discontinued on July 31, 2026.2,3

Despite widespread clinical use of non-FDA-approved multiallergen OIT formulations, no prior randomized trial had directly compared omalizumab with MOIT.¹ The OUTMATCH stage 2 trial addressed this gap across 10 US academic centers.¹

"There was a very low rate of dropouts in the omalizumab side," trial investigator Robert A. Wood, MD, professor of pediatrics, Johns Hopkins University School of Medicine, told HCPLive at the 2025 American Academy of Allergy, Asthma, & Immunology (AAAAI) meeting in San Diego.4

OUTMATCH stage 2 enrolled 117 participants (median age, 7 [1-29] years; 64 male [55%]) with allergy to peanuts and ≥ 2 other foods among milk, eggs, wheat, cashews, hazelnuts, or walnuts.¹ Participants completed 16 weeks of open-label omalizumab before randomization to double-blind MOIT with placebo omalizumab or omalizumab with placebo MOIT, followed by 44 weeks of blinded treatment.¹ MOIT was escalated to a goal maintenance dose of 1000 mg per food.¹

The primary end point was cumulative tolerated dose (CTD) of 4044 mg or greater for all 3 foods at the end-of-treatment food challenge.¹ In the intention-to-treat population, omalizumab achieved success in 36% of participants compared with 19% of participants receiving MOIT (odds ratio [OR], 2.6; 95% CI, 1.1-6.3; 

 =.03).¹ The per-protocol analysis, limited to participants who completed the study, showed no significant difference between arms (OR, 1.2; 95% CI, 0.5-3.3; 

Omalizumab Safety Versus MOIT in Food Allergy

Superiority for omalizumab extended to CTDs of 4044 mg or greater for 2 or more foods (OR, 3.3; 95% CI, 1.5-7.3; 

 =.002) and for individual foods including peanut (OR, 4.3; 95% CI, 1.9-9.7; 

 <.001), milk (OR, 6.2; 95% CI, 1.4-27.6;

 =.02), and egg (OR, 11.7; 95% CI, 1.9-70.2; 

=.004).¹ At a lower threshold relevant to accidental exposure, 72% of participants on omalizumab tolerated 444 mg or more of all 3 allergens compared with 39% of participants on MOIT.¹

Safety findings favored omalizumab across every measured category.¹ Participants receiving MOIT experienced more serious adverse events (31% vs 0%), events leading to discontinuation (22% vs 0%), and events treated with epinephrine (37% vs 7%).¹ Anaphylaxis occurred in 27% of MOIT participants versus 2% in the omalizumab arm, and 3 cases of biopsy-confirmed eosinophilic esophagitis occurred only in the MOIT group.¹

What is the difference in efficacy between omalizumab and multiallergen OIT for multifood allergy? 

In the OUTMATCH stage 2 intention-to-treat analysis, omalizumab achieved treatment success in 36% of participants compared with 19% for MOIT, though the difference was not significant in the per-protocol population.

How do the safety profiles of omalizumab and MOIT compare in multifood allergy treatment?


MOIT was associated with substantially higher rates of serious adverse events, epinephrine-treated reactions, and anaphylaxis than omalizumab, along with 3 cases of eosinophilic esophagitis not seen in the omalizumab arm.

Why did MOIT show a high rate of study discontinuation in OUTMATCH stage 2?


Nearly half of participants receiving MOIT discontinued treatment, primarily due to adverse events, compared with 12% in the omalizumab arm, a gap investigators say drove most of the intention-to-treat difference.

Discontinuation reached 49% in the MOIT arm compared with 12% for omalizumab, and investigators attributed most withdrawals to MOIT-related adverse events rather than a true efficacy gap among treatment completers.¹ A post hoc subgroup analysis suggested participants reaching the full 3000-mg MOIT maintenance dose had greater success rates than those at lower doses (54% vs 24%; 

 =.13), though the comparison was underpowered.¹

The investigators called for further comparative and cost-benefit research to guide individualized selection between anti-IgE and OIT strategies for multifood allergy.¹

“…although the ITT analysis demonstrated higher rates of treatment success with omalizumab across numerous end points, this difference was largely driven by the high rate of MOIT-related adverse events and study discontinuations rather than a difference in efficacy among those who completed treatment,” investigators concluded. “Both omalizumab and omalizumab-facilitated MOIT represent viable treatment options, each with distinct risk-benefit profiles that must be weighed in the context of individual patient needs and preferences.”

Wood RA, Togias A, Burk CM, et al. Treatment of multifood allergy with omalizumab or multiallergen oral immunotherapy: a randomized clinical trial. JAMA Pediatr. Published online July 27, 2026.

US Food and Drug Administration. FDA approves first medication to help reduce allergic reactions to multiple foods after accidental exposure. Accessed April 4, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-approves-first-medication-help-reduce-allergic-reactions-multiple-foods-after-accidental

With Palforzia® Ending, What’s Next for Peanut Allergy Patients. Allergy & Asthma Network. Published February 19, 2026. Accessed July 28, 2026. 

https://allergyasthmanetwork.org/news/palforzia-discontinued/

Omalizumab performs better than oral immunotherapy for food allergy, with Robert Wood, MD. HCPLive. Published April 21, 2026. Accessed July 28, 2026. 

https://www.hcplive.com/view/omalizumab-performs-better-than-oral-immunotherapy-food-allergy-with-robert-wood-md

Articles

OUTMATCH stage 2 compared anti-IgE therapy with multiallergen oral immunotherapy in pediatric-predominant patients allergic to peanut plus at least two other foods. After 16 weeks of open-label omalizumab, participants received blinded omalizumab or MOIT for 44 weeks. Intention-to-treat analyses favored omalizumab for achieving higher cumulative tolerated doses across multiple foods, including clinically relevant low-dose thresholds, but per-protocol results were similar. Marked MOIT toxicity drove discontinuations, narrowing apparent efficacy differences among completers.

In the OUTMATCH stage 2 randomized trial, omalizumab achieved greater intention-to-treat success than multiallergen oral immunotherapy.

News

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Clinical

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

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

Omalizumab Outperforms Multiallergen OIT for Multifood Allergy

Carolyn H. Baloh, MD, from the division of allergy and clinical immunology at Brigham and Women's Hospital, Harvard Medical School.

 FARE Registry Reveals Disparities in Seed and Spice Allergies

New data from the FARE (Food Allergy Research & Education) Patient Registry show 

 most often begin in childhood, occur at greater rates among Black, American Indian/Alaska Native, and Hispanic patients and those with lower household income, and can trigger reactions severe enough to require epinephrine.¹

Sesame allergy carries an estimated prevalence of 0.1% to 0.2%, but allergists increasingly encounter reactions to non-sesame seeds and spices as consumers turn to alternatives like sunflower seed butter.

 Until now, evidence on these triggers was limited mostly to case reports and single-center series.¹ The FARE registry, launched in 2017 and encompassing roughly 14,000 pediatric and adult participants, gave investigators the statistical power to characterize these under-recognized allergens nationally.¹

"This is the largest and most comprehensive analysis to date of patient-reported non-sesame seed and herb spice allergens, and allergies to these foods often present in childhood and are more prevalent among specific socioeconomic groups," said Carolyn H. Baloh, MD, from the Division of Allergy and Clinical Immunology, Brigham and Women's Hospital, Harvard Medical School. "Our hope is this information will help guide providers in the evaluation and treatment of these often hidden or under-recognized food allergens."

Non-Sesame Seed and Herb/Spice Allergen Patterns in the FARE Cohort

Investigators extracted deidentified survey data on 2601 participants reporting a sesame (n = 1195), non-sesame seed (n = 968), and/or herb/spice (n = 616) allergy from the FARE registry between August 24, 2017, and July 1, 2025.¹ The overall cohort was 51% male and 56% Caucasian, though demographics diverged sharply by allergen group.¹ Participants reporting only sesame allergy were significantly more likely to identify as White than those reporting only herb/spice allergy (P <.0001).¹

Black or African American (23.3%) and American Indian/Alaska Native (16.4%) race were particularly common among the herb/spice group.¹ Hispanic or Latino ethnicity was reported by 38% of the herb/spice group, versus 18% of the sesame group and 29% of the non-sesame seed group (P<.0001).¹ Household income < $25,000 was reported by 27% of the herb/spice-only group compared with 8% of the sesame-only group and 14% of the non-sesame seed-only group (P <.0001).¹

Sunflower (28%; n = 515), mustard (19%; n = 343), and flaxseed (14%; n = 256) were the top non-sesame seed allergens, while garlic (6%; n = 111), black pepper (6%; n = 110), cinnamon (5%; n = 96), ginger (5%; n = 95), and curry (5%; n = 94) led the herb/spice list.¹ Diagnosis occurred before 18 years old in roughly 80% of participants across all 3 groups, though diagnosis before 1 years old was significantly more common with sesame allergy (18%) than non-sesame seed (7%) or herb/spice allergy (2%) (P <.0001).¹

Epinephrine Use and Reaction Severity Across Allergen Groups

Epinephrine was administered for approximately one-third of reported reactions regardless of the causative allergen, per registry-wide descriptive data.¹ In the mutually exclusive analysis, epinephrine use was reported by 42% of participants with only sesame allergy, 40% with only non-sesame seed allergy, and 29% with only herb/spice allergy (P =.05).¹ Use of ≥ 1 epinephrine dose was numerically greater among the non-sesame seed-only group, though the difference did not reach statistical significance.¹

Biphasic reactions occurred across all 3 groups and were most frequent among participants with only herb/spice allergy (40%), compared with 17% in the sesame-only group and 34% in the non-sesame seed-only group.¹ Atopic comorbidities were common across allergen groups, with allergic rhinitis (46%), eczema (49%), and asthma (38%) frequently reported among sesame-allergic participants.¹ Sesame and non-sesame seed allergies were reportedly outgrown in 24% of respondents, compared with 46% of respondents with herb/spice allergy.¹

Investigators noted the registry relies on participant-reported and self-diagnosed data and could not stratify outcomes by allergist-confirmed diagnosis in all cases, pointing to a need for confirmatory studies incorporating oral food challenge or component-resolved testing.¹

“Participants reporting an herb or spice allergy in our study were more likely to report a lower family income and to identify as Black or African American, American Indian, Alaska Native, or Hispanic," Baloh concluded. “This really emphasizes the importance of including a diverse participant population in clinical studies and trials and a need to improve clinical practice to provide equitable care for everyone.”

Liu EY, Lopez S, Bufford JL, Laidlaw TM, Baloh CH. Seeds, Spices-Not Always so Nice: A Report on the FARE (Food Allergy Research & Education) Patient Registry. J Allergy Clin Immunol Pract. 2026. d

Patel A, Bahna SL. Hypersensitivities to sesame and other common edible seeds. Allergy. 441 2016 Oct;71(10):1405–13. doi:10.1111/all.12962 PubMed PMID: 27332789. 442 7.

Treffeisen ER, Mepyans C, Conroy ER, Baer HJ, Williams DN, Williams KA, et al. 443 Characterization and Incidence of Sunflower Seed Allergy in a Pediatric Allergy Clinic. J 444 Allergy Clin Immunol Pract. 2024 Nov;12(11):3081-3088.e6. doi:10.1016/j.jaip.2024.07.029 445 PubMed PMID: 39117271; PubMed Central PMCID: PMC11560651.

Videos

A FARE Patient Registry analysis finds herb and spice allergies disproportionately affect Black, Hispanic, and lower-income patients, Carolyn Baloh, MD, says.

FARE Registry Reveals Disparities in Seed and Spice Allergies

Cary James is the Chief Executive at The World Hepatitis Alliance

Nearly 9 in 10 Canadians report having little to no awareness of chronic hepatitis B (CHB), according to new survey findings released for World Hepatitis Day, highlighting persistent gaps in understanding of the infection’s role in liver cancer, prevention, and the importance of testing.

To better understand what these findings reveal about current hepatitis B awareness, barriers to diagnosis, and opportunities to accelerate progress toward elimination, HCPLive spoke with Cary James, chief executive officer of the World Hepatitis Alliance.

The global survey, commissioned and funded by GSK and conducted by Ipsos, found that only 31% of Canadian respondents considered CHB a high cancer risk, despite chronic hepatitis B being a major contributor to liver cancer globally. Additionally, only 14% of respondents reported having previously been tested for CHB, even though the infection affects an estimated 262,000 people in Canada.

The survey included approximately 5000 adults across Japan, Taiwan, China, Germany, and Canada, including 1061 Canadian respondents ≥ 18 years of age. Conducted ahead of World Hepatitis Day on July 28, the survey examined awareness of CHB, perceptions of cancer risk, testing behaviors, and understanding of prevention and treatment options.

CHB is a long-term viral infection that can remain undetected for years because many individuals experience few or no symptoms. Over time, untreated infection can contribute to serious liver complications, including cirrhosis and liver cancer. Globally, CHB accounts for approximately 56% of liver cancer cases and affects more than 240 million people worldwide.

The survey findings highlighted several gaps in public understanding of CHB:

Only 31% of Canadians identified CHB as a high cancer risk, ranking it lower than risk factors such as regular alcohol use and obesity.

Nearly 9 in 10 respondents reported knowing little to nothing about CHB.

Eleven percent said they had never heard of hepatitis B.

Only 8% believed they were likely to contract CHB.

Forty-five percent of respondents reported they had never been tested for hepatitis B because they had not considered testing or did not believe they were at risk.

More than half of respondents (55%) incorrectly believed there was no treatment available for CHB.

Approximately 3 in 4 respondents were unaware that hepatitis B vaccination can help prevent infection.

The findings come as public health organizations continue efforts to meet the World Health Organization’s goal of eliminating viral hepatitis as a public health threat by 2030. Updated Canadian guidelines emphasize universal screening, infant vaccination, and expanded treatment eligibility for individuals with CHB.

Despite available tools for prevention, diagnosis, and treatment, awareness remains a major challenge.

Q&A: Survey Reveals Low Awareness of Chronic Hepatitis B’s Link to Liver Cancer

: When you are looking at these new survey findings, what do they tell you about the current state of hepatitis B awareness?

 Well, it's not good. I think we knew it was not good, and we've done kind of similar surveys in the past and found the same thing. I mean, I think unfortunately, hepatitis B around the world is under understood, very misunderstood, and very stigmatized in many parts of the world. And yeah, people just don't realize the seriousness of it, or that's even within their community.

So there's so much to do about raising awareness, making people making sure people are aware and of the benefits of getting tested, even if they don't think that they, you know, could have ever been exposed before, and the benefits of treatment.

I mean, I think the cancer information is interesting because we did a survey in I think it was eight countries geographically around the world, and we found that the link between hepatitis and liver cancer is a very good motivator for testing. We asked people if they knew about hepatitis and liver cancer, and we got a very similar result to this survey, where about half said yes. Then if we asked them, "Now that you know that, would you be more likely to get tested?" three quarters said they would be more likely to get tested. This was true from North America to Asia—it was a universal finding.

Then we asked them, "If you tested positive, would you want treatment?" Again, about three quarters said they would want treatment.

So yeah, I think it's startling when you think about more than 200 million people are affected by chronic hepatitis B and just how little it is known and understood.

 What do you think these findings reveal about the biggest barriers that prevent people from getting tested or diagnosed earlier?

 Well, I think if you don't know about it, you can't test for it, right? If people just don't know about hepatitis, if they see a poster, they don't know what it is. They don't know if it could affect them. Even if you're doing awareness campaigns, that's a really big first barrier to overcome.

Number two, in a lot of countries—including some of the countries in this survey, which have quite well-developed health systems—you would expect these numbers to be a bit better. But sometimes accessing hepatitis B testing can be difficult. It's not always readily available through general practitioners, and there's not really an obvious place to get tested.

Plus, there's a really big stigma around hepatitis B, almost universally, I would say. It makes people hesitant to ask for a hepatitis test because they think there might be some judgment attached. It also makes healthcare providers nervous about offering a hepatitis B test if they think the patient would benefit from it because they don't want the patient to feel judged.

We find the same thing with other communicable diseases like HIV. So I think the stigma around hepatitis B is a really big barrier in more ways than just society—it also affects access to healthcare, testing, and treatment.

: One of the strongest themes in this survey is that many people don't perceive hepatitis B as a significant health risk. You also mentioned the stigma associated with it. Why do you think hepatitis B has remained outside the public conversation compared with so many other chronic diseases?

 Well, the diagnosis rates are so low. You probably don't know anyone who has chronic hepatitis B—at least in Europe. In Asia it's probably different. But if you're talking about Canada or Germany, diagnosis rates are quite low, so you've probably never heard of anyone having chronic hepatitis B.

Maybe if you're part of certain communities, like gay men and other men who have sex with men, you've heard someone talk about hepatitis B vaccination to prevent a sexually transmitted infection, but it's not really discussed outside of that context.

We also know that most hepatitis B acquired in adulthood results in an acute infection and doesn't become chronic. Chronic infection is mostly acquired from mother to child, and that's just not really understood.

An example of how under the radar hepatitis B can be comes from the UK. They started a pilot program where emergency departments did opt-out testing for hepatitis B, hepatitis C, and HIV. Everyone who had blood drawn was automatically tested unless they opted out.

Originally it was an HIV pilot, and hepatitis was added later. They expected to find mostly HIV and hepatitis C cases and figured hepatitis B was worth including too. Instead, they found four times more undiagnosed hepatitis B than anything else. They identified thousands of undiagnosed hepatitis B cases in London—so many that hepatology departments wanted to stop emergency department testing because they couldn't manage the number of patients needing follow-up.

No one expected that. Many of the people testing positive were first- and second-generation diaspora communities from high-prevalence countries. If that's true in London, it's probably true in Berlin, Madrid, and other cities with significant migration from high-prevalence countries.

So yes, I think hepatitis B is very misunderstood in most places, both by health systems and by the general population.

: When people don't recognize hepatitis B as a long-term health threat, what are the real-world consequences that you're seeing for patients and for public health?

 Well, untreated hepatitis B can lead to very serious disease. It can lead to cirrhosis, and cirrhosis often leads to liver cancer.

Because those complications often develop later in life, the connection isn't always made that the liver disease could have been caused by hepatitis B.

We're a network of community-based organizations, and we've heard too many stories where generations of families have lost relatives to liver cancer before anyone thought to test for hepatitis B. Then finally someone in the youngest generation gets tested, and they discover hepatitis B has been present in the family for generations.

It's very serious if it's not identified and treated. But many of those deaths are simply recorded as liver disease or liver cancer without connecting them back to hepatitis B.

That's one reason we've worked closely with cancer organizations to make that connection more visible and to incorporate hepatitis B testing into cancer prevention programs.

Last year, at the United Nations High-Level Meeting on Noncommunicable Diseases, we were successful in getting hepatitis testing, treatment, and hepatitis B vaccination recognized as cancer prevention measures and as a way to improve outcomes through earlier diagnosis.

So the impact can be devastating, but it often goes unrecognized if people are never tested.

: The World Health Organization has set a goal of eliminating viral hepatitis as a public health threat by 2030. Looking at these survey findings and data, where do you see the biggest opportunities to move us closer to that goal?

 Well, today is World Hepatitis Day, and we just had a high-level event here in Rio during the AIDS Conference. The Director-General, Dr. Tedros, was the keynote speaker. We also had the Ministers of Health from Brazil and Honduras, along with many other speakers.

I think the really important thing is getting more people tested and more people on treatment. Obviously, we'd like dedicated hepatitis programs, but at the World Hepatitis Alliance we really focus on having a whole health system response to hepatitis.

That means integrating hepatitis into primary care, into cancer and noncommunicable disease programs, and here at the AIDS Conference we've been talking a lot about triple elimination—preventing mother-to-child transmission of HIV, hepatitis, and syphilis together.

As part of that, women are tested for hepatitis B, and if they test positive they're offered treatment. It's about using the infrastructure that's already been built for HIV and expanding it, and that's really gaining momentum.

Another important area is working with harm reduction programs and communities affected by unsafe injection practices. Hepatitis B is often underreported in those settings as well.

So I think there's value in both dedicated hepatitis responses and integrated approaches. Countries sometimes think they need to fund an entirely new program, but they don't. They can make incremental additions to the healthcare systems they already have, and those relatively small changes could make a huge difference.

 We always say that this could be one of the great global health achievements of our time—eliminating hepatitis B—because we already have all of the tools. And now, with new curative treatments on the horizon, even being able to functionally cure people represents an incredible opportunity.

We're really urging governments and health systems to take up that challenge and be the ones that make this historic decision to do something.

I know we haven't really talked about cures or new therapies, but I think it's important to mention them because of what's happening with HIV treatment.

At the moment, many HIV treatments contain tenofovir disoproxil fumarate (TDF), which also treats hepatitis B. That means there are millions of people—particularly in Africa—with undiagnosed hepatitis B who are unknowingly receiving treatment through their HIV medication.

As HIV care moves toward long-acting injectable therapies that don't contain TDF, we need to make sure those patients' hepatitis B is also being treated. If someone struggles with taking daily HIV medication, they're likely to face the same challenge with daily hepatitis B medication.

That's why developments like functional cures offer real hope. In the future, someone could receive a long-acting injectable for HIV while also accessing a functional cure for hepatitis B. That's still some way off, but when you think about how these innovations are evolving together, they have the potential to completely change the global landscape.

Editor’s Note: Cary James is chief executive officer of the World Hepatitis Alliance.

GlaxoSmithKline Inc. New survey reveals Canadians underestimate chronic hepatitis B and its link to liver cancer. CNWGroupJuly 28, 2026. Accessed July 28, 2026. https://www.newswire.ca/news-releases/new-survey-reveals-canadians-underestimate-chronic-hepatitis-b-and-its-link-to-liver-cancer-840531048.html

Survey data show profound Canadian knowledge deficits around chronic hepatitis B (CHB), with low perceived cancer risk, limited vaccination awareness, and minimal testing uptake despite substantial national prevalence. Misconceptions about treatment availability persist, and many respondents report not seeking testing because they feel low risk. Expert commentary highlights stigma, fragmented access pathways, and underdiagnosis in diaspora communities as key drivers, with real-world consequences including unrecognized familial transmission and preventable cirrhosis and hepatocellular carcinoma. Progress toward 2030 elimination hinges on scaling screening, normalizing testing, and integrating hepatitis services into HIV, primary care, and cancer prevention programs.

World Hepatitis Day survey findings reveal gaps in chronic hepatitis B awareness and liver cancer risk perception, with Cary James discussing elimination efforts.

Hepatology

Survey Reveals Low Awareness of Chronic Hepatitis B’s Link to Liver Cancer

Walter J. Liszewski, MD, is an associate professor of dermatology and cancer epidemiology at Northwestern University Feinberg School of Medicine.

Treatment selection in atopic dermatitis is becoming increasingly personalized as therapeutic options expand.

Biologics, JAK inhibitors, and advanced topicals each play distinct roles in long-term disease management.

Biomarkers and real-world evidence may help guide more individualized treatment decisions in the future.

 has created new opportunities for personalized care, but it has also made treatment selection increasingly complex, according to Walter Liszewski, MD.

Revolutionizing Atopic Dermatitis (RAD) Conference

 in Nashville, Liszewski discussed how clinicians are navigating a growing number of oral, biologic, and topical drugs while tailoring treatment plans to individual patient needs.

What Factors Should Guide Atopic Dermatitis Treatment Selection? With Walter Liszewski, MD

Liszewski explained that the increase in available therapies has shifted the conversation toward shared decision-making. Rather than focusing solely on efficacy, clinicians can now consider patient preferences regarding route of administration, treatment speed, potential adverse effects, and long-term disease management. He added that having multiple therapeutic options is especially valuable for patients who do not respond adequately to an initial therapy, providing clinicians with additional strategies when treatment failure occurs.

Addressing Treatment Gaps in Atopic Dermatitis

When discussing advanced systemic therapies, Liszewski noted that Janus kinase (JAK) inhibitors remain highly effective options, although current US Food and Drug Administration labeling generally reserves them for patients who have already received another systemic therapy. He suggested that as additional long-term safety data continue to emerge, dermatologist confidence in prescribing JAK inhibitors is likely to grow. Meanwhile, advanced topical therapies continue to fill an important role for patients with persistent disease who may not require biologic treatment, while also serving as adjunctive therapy to address localized areas of residual disease in patients receiving systemic agents.

Liszewski acknowledged that sequencing therapy after treatment failure remains one of the least defined areas in eczema management. Current evidence is limited, with clinicians often relying on case reports and real-world experience when considering combination therapy, phototherapy, or dose adjustments. He noted that emerging therapies with new mechanisms of action may help expand these options in the coming years.

Looking Ahead: The Future of Eczema Treatment

Looking to the future, Liszewski highlighted the growing importance of patient-reported outcomes, including measures of itch and sleep, alongside objective skin clearance. He also pointed to biomarkers and accumulating real-world evidence as promising tools that could help clinicians better identify which patients are most likely to benefit from specific therapies. While an expanding evidence base may increase the complexity of treatment decisions, he emphasized that it will ultimately support more individualized, patient-centered care.

Disclosures: Liszewski did not have any relevant disclosures of note.

Liszewski W, Rubin C, Cotter D, et al. Session 4: Medical Crossfire® and Clinical Case Challenge. Session presented at: 2026 Revolutionizing Atopic Dermatitis Conference; June 17-19, 2026; Nashville, TN.

Liszewski W. Q&A: How Is Treatment Selection Changing in Atopic Dermatitis? HCPLive. July 27, 2026. Accessed July 28, 2026. 

https://www.hcplive.com/view/q-a-how-treatment-selection-changing-atopic-dermatitis-

How is drug selection evolving in atopic dermatitis? Walter Liszewski, MD, discusses personalized therapy and long-term care.

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.

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.

Conference

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

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.

Image Credit: US Food and Drug Administration

 has granted Fast Track designation to HTX-001 for the treatment of 

nonobstructive hypertrophic cardiomyopathy (nHCM)

HAYA Therapeutics announced the designation on July 28, 2026. The designation provides access to an expedited development pathway for therapies intended to treat serious conditions and address an unmet medical need.

“Patients with nonobstructive HCM are seeking treatments that go beyond management of symptoms. This designation reflects the urgency of delivering better therapeutic options,” Jordan Shin, MD, PhD, chief medical officer of HAYA Therapeutics, said in a statement. “With our Phase I clinical trial already underway, Fast Track designation allows us to work more closely with the FDA as we advance HTX-001, our investigational precision RNA-guided therapy designed to reprogram disease-driving cardiac fibroblasts - the sentinel effector cells that act to drive fibrosis and remodeling in the myocardium.”

Fast Track status does not constitute marketing approval or establish efficacy or safety. Instead, the designation may provide more frequent interactions with the FDA during clinical development and permit rolling submission of portions of a new drug application or biologics license application when relevant requirements are met.

What FDA Fast Track Designation Means for HTX-001

Under FDA guidance, Fast Track designation is available for drugs intended to treat serious conditions when nonclinical or clinical data demonstrate potential to address an unmet medical need. The evidence needed can vary according to the product’s development stage and the availability of existing treatments. Early in development, a mechanistic or nonclinical rationale may contribute to the agency’s assessment; later requests generally can incorporate clinical evidence.

Benefits may include more frequent meetings and written communications with the FDA concerning study design, biomarker strategy, development plans, and data needed for a future application. A product also may become eligible for rolling review, allowing the agency to review completed application sections before receipt of the full submission. Fast Track products can be considered separately for priority review or accelerated approval if applicable criteria are satisfied.

The designation does not guarantee use of those additional programs, a shortened clinical development timeline, acceptance of a marketing application, or eventual approval. Standard requirements for demonstrating safety, efficacy, and manufacturing quality remain in place.

What Is Known About HTX-001 and the Supporting Evidence

HTX-001 is a differentiated antisense oligonucleotide, designed to downregulate the heart stress-specific lncRNA 

, which is overexpressed in HCM. Investigators believe that, by targeting 

 in cardiac myofibroblasts, HTX-001 may promote precision reprogramming of this cell state towards a healthy phenotype.

A Phase I trial investigating HTX-001 is currently underway: on May 20, 2026, HAYA Therapeutics announced that the first cohort of patients had been fully dosed. The trial aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics in both healthy patients and those with nHCM across a series of multiple-ascending dose cohorts.

HAYA Therapeutics receives FDA Fast Track designation for HTX-001. Business Wire. Published July 28, 2026. 

https://www.businesswire.com/news/home/20260728393451/en/HAYA-Therapeutics-Receives-FDA-Fast-Track-Designation-for-HTX-001

Expedited Programs for Serious Conditions—Drugs and Biologics: Guidance for Industry.

HAYA Therapeutics. HAYA Therapeutics Announces First Cohort Dosed in Phase 1 Clinical Trial of HTX-001. May 20, 2026. Accessed July 28, 2026. 

https://www.hayatx.com/haya-therapeutics-announces-first-cohort-dosed-in-phase-1-clinical-trial-of-htx-001-an-investigational-precision-cellular-reprogramming-therapy-for-cardiac-fibrosis/

The FDA has granted Fast Track designation to HTX-001 for nonobstructive hypertrophic cardiomyopathy, enabling closer FDA engagement and potential rolling review while preserving standard evidentiary requirements for safety, efficacy, and CMC. Eligibility rests on potential to address unmet need in a serious condition, supported early by mechanistic or nonclinical rationale and later by clinical data. HTX-001 is an antisense oligonucleotide targeting the stress-induced lncRNA WISPER to modulate cardiac myofibroblast state and myocardial fibrosis/remodeling. A Phase I multiple-ascending-dose study is underway, with the first cohort fully dosed.

The FDA has officially granted Fast Track designation to HTX-001 for the treatment of non-obstructive hypertrophic cardiomyopathy.

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Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for 

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FDA Grants Fast Track Designation to HTX-001 for nHCM