Abigail Brooks is an assistant managing editor for 

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

The US Food and Drug Administration (FDA) has approved a new higher dose of Novo Nordisk’s semaglutide (Wegovy; Wegovy HD) injection 7.2 mg to be used along with a reduced calorie diet and increased physical activity to help adults with obesity lose weight and keep it off, provided they have tolerated the 2.4 mg dosage for ≥ 4 weeks and additional weight reduction is clinically indicated.

As described in a March 19, 2026, press release from the Company, the approval is based on the results from the STEP UP trial program. Of note, the new update supplements the existing semaglutide label, which also has distinct indications for semaglutide not offered by any other GLP-1 medication for weight loss.

"Wegovy® HD represents an important new tool in obesity management, allowing clinicians to better tailor treatment strategies and help improve outcomes," W Timothy Garvey, MD, professor of medicine and director of the Diabetes Research Center at the University of Alabama at Birmingham, said in a statement. "The weight loss demonstrated with Wegovy® HD could reshape healthcare professionals' expectations about what outcomes are possible for their patients with Wegovy®."

The FDA initially approved semaglutide 2.4 mg in June 2021 for chronic weight management in adults with obesity or overweight, marking a landmark approval for the GLP-1 RA class. A label expansion in March 2024 added an indication for reduction of cardiovascular risk among adults with obesity or overweight, based on results from the SELECT trial.

Prior to the approval of Wegovy HD, the highest approved dose of semaglutide injectable for weight loss was 2.4 mg, which is also indicated, along with a reduced calorie diet and increased physical activity, to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and with either obesity or overweight.

The newest approval is based on the results of the STEP UP trial program. STEP UP was a phase 3b 72-week randomized, double-blinded, placebo-controlled and active-controlled superiority trial designed to evaluate the efficacy and safety of semaglutide injection 7.2 mg compared to semaglutide injection 2.4 mg and placebo as an adjunct to lifestyle intervention. A total of 1407 adults with BMI ≥30 kg/m2 without diabetes were included in the trial.

The primary objective was to demonstrate superiority of semaglutide 7.2 mg against placebo on weight loss after 72 weeks with respect to the percentage change in body weight and the proportion of participants achieving weight loss of ≥ 5%. Select confirmatory secondary endpoints included number of participants achieving ≥10%, 15%, 20% and 25% weight loss, with semaglutide 7.2 mg vs placebo (and for ≥ 20% and 25%, semaglutide 7.2 mg vs semaglutide 2.4 mg).

In total, 1407 participants were randomly assigned in a 5:1:1 ratio to receive once-weekly subcutaneous semaglutide 7.2 mg, 2.4 mg, or placebo, alongside lifestyle intervention, for 72 weeks.

Topline results from the trial were announced in January 2025 and showed statistically significant and superior weight loss at 72 weeks with semaglutide 7.2 mg, compared with placebo, irrespective of treatment adherence.

As described in the release from Novo Nordisk, for those taking Wegovy HD, 89% achieved ≥ 5% body weight loss versus 38% taking placebo (from a baseline body weight of 248 lbs).

The most common adverse reactions reported with Wegovy HD were nausea, vomiting, dysesthesia, constipation, abdominal pain, fatigue, headache, dizziness, hair loss and flatulence. In clinical trials, dysesthesia was reported at a higher rate with Wegovy HD compared to semaglutide 2.4 mg and placebo.

Events related to a clinical picture of altered skin sensation such as sensitive skin, hyperesthesia, dysesthesia and paresthesia were reported by a greater proportion of participants, and at a higher rate, in the Wegovy HD arm (22%), compared to treatment with semaglutide 2.4 mg (6%) and placebo (0.3%).

As described in the press release from Novo Nordisk, Wegovy HD will be available in April through all channels where patients can access semaglutide, including 70,000 plus pharmacies in the US like CVS and Costco, select telehealth providers, NovoCare Pharmacy, GoodRx, and others.

"We are excited to bring Wegovy® HD injection to adults with obesity who are looking for powerful weight loss, as no other weight loss medicine has been studied to show superiority to Wegovy® HD," said Jamey Millar, executive vice president, US Operations of Novo Nordisk. "In addition to significant weight loss, Wegovy® is the only GLP-1 for adults with obesity that is proven to reduce the risk of events such as stroke, heart attack, or cardiovascular death in those who also have known heart disease. Today's milestone expands the strong clinical profile of Wegovy® that includes multiple indications that no other GLP-1 for weight loss can claim."

Novo Nordisk. FDA approves Novo Nordisk's new Wegovy® HD injection, delivering the highest weight loss to date for a Wegovy® injection, adding to its already expansive clinical profile. March 19, 2026. Accessed March 19, 2026. 

https://www.prnewswire.com/news-releases/fda-approves-novo-nordisks-new-wegovy-hd-injection-delivering-the-highest-weight-loss-to-date-for-a-wegovy-injection-adding-to-its-already-expansive-clinical-profile-302718982.html

Iapoce C. Semaglutide 7.2 mg Displays 20.7% Weight Loss in Phase 3b STEP UP Trial. HCPLive. January 17, 2025. Accessed March 19, 2026. 

https://www.hcplive.com/view/semaglutide-7-2-mg-displays-20-7-weight-loss-in-phase-3b-step-up-trial

Articles

FDA approval of semaglutide 7.2 mg (Wegovy HD) expands dosing options for chronic weight management in adults with obesity without diabetes who have tolerated 2.4 mg for at least four weeks and need further weight reduction. The decision is supported by STEP UP, a 72-week phase 3b randomized, double-blind, placebo- and active-controlled superiority trial comparing 7.2 mg with 2.4 mg and placebo alongside lifestyle intervention. High-dose semaglutide increased clinically meaningful weight loss but showed higher rates of altered skin-sensation events.

The approval is based on results from the STEP UP trial program showing substantial weight loss in adults with obesity. 

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FDA Approves Higher Dose Semaglutide (Wegovy HD) Injection 7.2 mg for Obesity

Allergist-immunologist at Yale New Haven Hospital

Non-Narcotic Analgesic Allergy Labels in Pregnancy Drive Suboptimal Care and Adverse Outcomes, With Chang Su, MD

Unverified drug allergy labels are a well-documented driver of suboptimal prescribing — but a large population-based study presented at the 

American Academy of Allergy, Asthma & Immunology (AAAAI)

 2026 Annual Meeting held in Philadelphia, Pennsylvania, from February 27 to March 2, now extends that harm into the perinatal setting, showing that mothers carrying non-narcotic analgesic allergy labels face significantly elevated risks of eclampsia, preterm birth, and adverse neonatal outcomes compared to those without such labels.

To discuss the findings, we spoke with Chang Su, MD, allergist-immunologist at Yale New Haven Hospital, who conducted the research during her time at University of California San Francisco. The study drew on the Study of Outcomes in Mothers and Infants, a population-based cohort of all singleton livebirths in California between 2016 and 2021 (N = 2,244,210), of which 10,460 were born to mothers carrying non-narcotic analgesic allergy labels (NNAALs). After adjustment for maternal characteristics, NNAALs were significantly associated with increased rates of eclampsia (aRR, 1.5, 95% CI, 1.06-2.12), preterm birth (aRR, 1.21, 95% CI, 1.14-1.28), NICU admission (aRR, 1.17, 95% CI, 1.10-1.25), and neonatal withdrawal syndrome (aRR, 1.51, 95% CI, 1.24-1.84), as well as longer mean infant hospital stays (

 <.0001). A decreased rate of large-for-gestational-age infants was also observed (aRR, 0.92, 95% CI, 0.87-0.98). No significant associations were found with maternal preeclampsia, small-for-gestational-age infants, major structural birth defects, or 5-minute APGAR score below 7.

Su highlighted 2 primary mechanisms through which NNAALs appear to be shaping obstetric management — and outcomes — in ways that diverge from clinical guidelines. First, aspirin is recommended for preeclampsia prevention in up to 85% of pregnant patients with relevant risk factors, yet patients carrying an NSAID or aspirin allergy label are substantially less likely to receive it, even when indicated. The significantly elevated eclampsia risk in the NNAAL cohort — a condition that prophylactic aspirin is specifically intended to prevent — is consistent with that gap in guideline-concordant care, though Su was careful to note the association cannot establish causality with certainty. Second, non-narcotic analgesics are the recommended first-line treatment for postpartum pain, and prior studies have shown that patients with NNAALs receive opioids at higher rates and higher doses postpartum — a prescribing pattern with downstream implications in the context of the ongoing opioid epidemic. Together, Su argued, these findings make a strong case that proactive allergy de-labeling should be considered as part of routine prenatal care, not reserved for specialist referral after an adverse event has already occurred.

“People with NNAALs have a higher risk of eclampsia, whether that's because they're not started on aspirin when they need to or due to other reasons… but it does seem like when patients are less likely to receive the recommended preventative care, that that leads to the adverse outcome that it's aiming to prevent,” Su said.

Su has no relevant disclosures to report.

1. Su C, Baer R, Otani I, Schatz M, Chambers C. The relationship between maternal non-narcotic analgesics allergy labels and maternal and fetal outcomes: results from a large, administrative cohort. Presented at: AAAAI 2026 Annual Meeting, February 27-March 2, Philadelphia, Pennsylvania. Abstract #L24

2. Non-Narcotic Analgesics Allergy Labels Linked to Adverse Maternal and Fetal Outcomes. News release. AAAAI. February 26, 2026. 

https://www.aaaai.org/about/news/news/2026/narcotic

Videos

Su described how NNAALs drive management decisions in pregnancy and post partum care.

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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.

Eli Lilly and Company have announced positive topline results from the phase 3 TRANSCEND-T2D-1 trial assessing the efficacy and safety of retatrutide, an investigational first-in-class GIP, GLP-1 and glucagon triple hormone receptor agonist, as an adjunct to diet and exercise in people with type 2 diabetes and inadequate glycemic control.

As described in a March 19, 2026, release from the Company, in the study, retatrutide met the primary and all key secondary endpoints, delivering superior A1C reduction and weight loss at 40 weeks compared to placebo, using both the efficacy and treatment-regimen estimands.

"For many people with type 2 diabetes, it is a struggle to achieve both A1C control and weight loss, since obesity has historically been harder to treat for those with type 2 diabetes," Kenneth Custer, PhD, executive vice president and president, Lilly Cardiometabolic Health, said in a statement. "With triple agonist retatrutide, we set out to make a molecule that could help patients achieve substantial A1C reduction and weight loss. These results support the remarkable potential of this novel molecule for people living with type 2 diabetes, with up to 2% A1C improvement and nearly 17% weight loss in 40 weeks of treatment."

Retatrutide is an investigational once-weekly triple hormone receptor agonist that activates the body's receptors for GIP, GLP-1, and glucagon. Lilly is studying retatrutide in multiple phase 3 clinical trials to evaluate its potential efficacy and safety in obesity and overweight with ≥ 1 weight-related medical problem, type 2 diabetes, knee osteoarthritis, moderate-to-severe obstructive sleep apnea, chronic low back pain, cardiovascular and renal outcomes, and metabolic dysfunction-associated steatotic liver disease.

Lilly announced positive topline results from the phase 3 TRIUMPH-4 clinical trial evaluating the safety and efficacy of retatrutide in adults with obesity or overweight and knee osteoarthritis, and without diabetes, as an adjunct to healthy diet and physical activity in December 2025. In the trial, participants taking retatrutide 12 mg lost an average of 28.7% of their body weight at 68 weeks.

Its use in people with type 2 diabetes and inadequate glycemic control is being assessed in TRANSCEND-T2D-1, a phase 3, 40-week, randomized, double-blind, placebo-controlled study comparing the efficacy and safety of retatrutide with placebo. The study randomly assigned 537 participants in a 1:1:1:1 ratio to receive either retatrutide 4 mg, 9 mg or 12 mg, or placebo.

The objective of the study was to demonstrate that retatrutide is superior to placebo in A1C reduction from baseline after 40 weeks, in adults with type 2 diabetes who have not taken any anti-diabetes medications for ≥ 90 days prior to visit 1, and are naïve to insulin therapy except for gestational diabetes. Study participants had A1C between ≥7.0% and ≤9.5% and a BMI of ≥23 kg/m2 at visit 1.

Participants randomized to retatrutide initiated treatment with 2 mg once-weekly and increased the dose in a step-wise approach every four weeks until reaching the target dose of 4 mg (via one step at 2 mg), 9 mg (via steps at 2 mg, 4 mg and 6 mg) or 12 mg (via steps at 2 mg, 4 mg, 6 mg and 9 mg).

For the primary endpoint, results showed participants taking retatrutide achieved average A1C reductions of up to 2.0%, using the efficacy estimand. For a key secondary endpoint, participants taking retatrutide lost up to an average of 36.6 lbs (16.8%), using the efficacy estimand. Weight loss continued through the end of the treatment period.

Of note, retatrutide also showed clinically meaningful improvements from baseline across key cardiovascular risk factors, including non-HDL cholesterol, triglycerides and systolic blood pressure.

Consistent with the types of adverse events seen in clinical trials for other incretin-based therapies, the most common adverse events among participants treated with retatrutide (4 mg, 9 mg, 12 mg) were nausea (16.4%, 19.5%, 26.5%, respectively vs 3.7% with placebo), diarrhea (18.7%, 26.3%, 22.8%, respectively vs 4.5% with placebo) and vomiting (15.7%, 15.0%, 17.6%, respectively vs 2.2% with placebo), and occurred primarily during dose escalation.

Incidence of dysesthesia occurred in 4.5%, 2.3% and 4.4% (4 mg, 9 mg and 12 mg, respectively) of patients treated with retatrutide, compared to 0.0% with placebo. Discontinuation rates due to adverse events were 2.2%, 4.5% and 5.1% with retatrutide 4 mg, 9 mg and 12 mg, respectively, compared to 0.0% with placebo.

Lilly described plans to present detailed TRANSCEND-T2D-1 results at the American Diabetes Association Scientific Sessions in June and publish them in a peer-reviewed journal. Additional results from the retatrutide clinical trial program are expected over the next year.

Lilly. Lilly's triple agonist, retatrutide, demonstrated significant reductions in A1C and weight in first Phase 3 trial for treatment of type 2 diabetes. March 19, 2026. Accessed March 19, 2026. 

https://www.prnewswire.com/news-releases/lillys-triple-agonist-retatrutide-demonstrated-significant-reductions-in-a1c-and-weight-in-first-phase-3-trial-for-treatment-of-type-2-diabetes-302718589.html

Lilly. Lilly's triple agonist, retatrutide, delivered weight loss of up to an average of 71.2 lbs along with substantial relief from osteoarthritis pain in first successful Phase 3 trial. December 11, 2025. Accessed March 19, 2026. 

https://investor.lilly.com/news-releases/news-release-details/lillys-triple-agonist-retatrutide-delivered-weight-loss-average

Lilly reported positive topline phase 3 data for once-weekly retatrutide, a first-in-class GIP/GLP-1/glucagon triple receptor agonist, in adults with type 2 diabetes inadequately controlled on no recent antihyperglycemic therapy. In TRANSCEND-T2D-1 (n=537; 40 weeks), retatrutide met the primary and all key secondary endpoints, achieving up to 2.0% A1C reduction and up to 16.8% mean weight loss versus placebo, with continued weight loss through week 40. Safety was characterized mainly by dose-escalation gastrointestinal events and low discontinuation rates.

The first-in-class GIP, GLP-1 and glucagon triple hormone receptor agonist delivered superior A1C reduction and weight loss at 40 weeks in people with type 2 diabetes.

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Retatrutide Delivers A1C Reduction, Weight Loss in Phase 3 TRANSCEND-T2D-1 Trial

Maya Clark Cutaia, PhD, RN, is the inaugural Evelyn Lauder Associate Dean for Nurse Practitioner Programs and Professor at the Hunter-Bellevue School of Nursing at Hunter College.

Neighborhood Disadvantage and Its Downstream Effects on Equitable Kidney Care, With Maya Clark Cutaia, PhD, RN

Neighborhood disadvantage creates barriers to kidney care at every stage of the continuum, from chronic kidney disease (CKD) diagnosis to disease progression to kidney failure requiring transplantation.

 is a place-based measure, defined as 1/5th of a population living below the federal poverty line, and with indices such as the Area Deprivation Index (ADI). Measurable data from the US Census Bureau identified 24 million Americans living in disadvantaged neighborhoods, with a disproportionate amount of racial and ethnic families residing within these communities. For example, only 4.3% of white Americans live in a disadvantaged neighborhood compared to 20.9% of black Americans.

“Unfortunately, for many of the patients that I come in contact with that are facing, you know, access barriers they present far later than I'd like, often after years of silent disease and silent decline, because that earlier phase of chronic kidney disease, which is typically asymptomatic… the screening and follow up may be inconsistent, or, in a lot of cases, non existent,” said Maya Clark Cutaia, PhD, RN, inaugural Evelyn Lauder Associate Dean for Nurse Practitioner Programs and Professor at Hunter-Bellevue School of Nursing at Hunter College.

Clark highlights how subtle clinical biases can compound the problem, influencing who receives close monitoring, early counseling, and timely nephrology referral. These gaps accumulate over time, allowing CKD to advance before intervention begins.

Even for patients who reach advanced disease, geography remains a significant barrier. Clark Cutaia points out that some patients travel 6 to 8 hours to reach a transplant center, an unsustainable burden for those who are working, caregiving, or managing multiple conditions. Transplant programs often assume resources and support structures that simply don't reflect the realities of disadvantaged communities.

“Recognizing, yes, I now have a person who's in a disenfranchised neighborhood. I should be trying even harder to get some of that… preemptive care screening available to them so that they don't end up having the same outcome… doing some of these referrals sooner, the handoff sooner, getting them connected with resources, sooner, as opposed to waiting for us to have, you know, a negative outcome, or for these patients to become symptomatic, because we know that that is going to likely be their end game."

social and neighborhood context into every CKD care

 plan is now a core clinical competency for anyone committed to equitable kidney care.

Editor’s Note: Clark Cutaia reports no relevant disclosures.

Christie-Mizell CA. Neighborhood Disadvantage and Poor Health: The Consequences of Race, Gender, and Age among Young Adults. 

International Journal of Environmental Research and Public Health

Li Y, Menon G, Kim B, et al. Residential Neighborhood Disadvantage and Access to Kidney Transplantation. 

https://doi.org/10.1001/jamanetworkopen.2025.49679

An expert breaks down how poverty, limited healthcare access, and geographic barriers delay CKD diagnosis, reduce transplant access, and widen health disparities, and what clinicians can do about it.


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.

2026 American Academy of Dermatology (AAD)

 Annual Meeting arrives at a pivotal moment for the field, with a slate of late-breaking data poised to reshape treatment paradigms across some of dermatology's most challenging conditions.

From atopic dermatitis and plaque psoriasis to hidradenitis suppurativa (HS) and dermatomyositis, this year's program is headlined by phase 3 readouts that represent years of clinical development, and in several cases, potential first-in-class approvals that could redefine the standard of care.

Taken together, the sessions reflect a broader maturation of the dermatology pipeline, one increasingly defined by oral precision therapies, novel biologic mechanisms, and a growing willingness to tackle rare and historically underserved diseases head-on.

Efficacy and Safety of Monotherapy Amlitelimab, a Non-Depleting Anti-OX40 Ligand Antibody, in Moderate-to-Severe Atopic Dermatitis: 24-Week Results From the Pivotal COAST 1 and COAST 2 Phase 3 Trials and Efficacy and Safety of Amlitelimab, a Non-Depleting Anti-OX40 Ligand Antibody, in Combination With Topical Therapy in Participants With Moderate-to-Severe Atopic Dermatitis: 24-Week Results From the SHORE Phase 3 Trial

Presenter: Eric Lawrence Simpson, MD, FAAD

Sanofi’s amlitelimab, a non-depleting anti-OX40 ligand monoclonal antibody, consolidates 24-week data from three pivotal phase 3 studies. COAST 1 (n=601) met all primary and key secondary endpoints across Q4W and Q12W dosing. SHORE met all EU estimand primary and key secondary endpoints in combination with topical corticosteroids. COAST 2 met the US estimand co-primary endpoint, narrowly missing EU co-primary endpoints.

 Global regulatory submissions are planned for H2 2026.

Efficacy and Safety of Abrocitinib in Patients with Chronic Hand Eczema: A Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial

Presenter: Robert Bissonnette, MSc, MD, FAAD

Pfizer’s abrocitinib (Cibinqo), an oral selective JAK1 inhibitor approved for moderate-to-severe atopic dermatitis, presents phase 3 results from the first randomized, placebo-controlled trial dedicated to chronic hand eczema (CHE). Prior phase 2b data (HAWK) established proof-of-concept for JAK1 inhibition in CHE.

 A positive outcome would support a label expansion for Cibinqo, positioning abrocitinib as the first oral JAK inhibitor with dedicated pivotal evidence in this indication. AAD 2026 marks the first public disclosure of the full trial results.

Envudeucitinib (ESK-001) in moderate-to-severe plaque psoriasis: 24-week results from the randomized, double-blind, active comparator- and placebo-controlled, Phase 3 ONWARD 1 and 2 studies

Alumis’ envudeucitinib, a highly selective oral TYK2 inhibitor, met all co-primary and ranked secondary endpoints in both phase 3 ONWARD studies (total n > 1,700), with superiority over placebo and apremilast (

< .0001). Across both trials, 74% of patients achieved PASI 75 at week 16; by week 24, approximately 65% achieved PASI 90 and more than 40% achieved PASI 100, with no new safety signals.

 Full 24-week data will be presented publicly for the first time at AAD 2026. An NDA filing is planned for H2 2026.

Efficacy and Safety of Upadacitinib in Adolescents and Adults for Treatment of Non-Segmental Vitiligo: Results of Two Phase 3 Studies (Viti-Up)

AbbVie’s upadacitinib (Rinvoq) 15 mg once daily met both co-primary endpoints across two replicate phase 3 Viti-Up studies (combined n≈614) in adults and adolescents ≥12 years with non-segmental vitiligo. T-VASI 50 at week 48 was achieved by 19.4% and 21.5% of treated patients versus 5.9% on placebo; F-VASI 75 by 25.2% and 23.4% versus 5.9% and 6.9%.

 Regulatory submissions have been filed with the FDA and EMA. If approved, upadacitinib would be the first systemic therapy indicated for vitiligo.

Concomitant therapy with ixekizumab plus tirzepatide in adults with psoriatic arthritis and overweight or obesity demonstrated superior disease control compared to ixekizumab alone: results from the Ph3b TOGETHER-PsA trial

Eli Lilly’s TOGETHER-PsA is the first randomized trial to test whether co-treating obesity alongside a biologic improves psoriatic arthritis outcomes. In the phase 3b study (n=271), 31.7% of patients receiving ixekizumab (Taltz) plus tirzepatide (Zepbound) achieved the composite primary endpoint of ACR50 plus ≥10% weight reduction at week 36 versus 0.8% on ixekizumab alone (

< .001). ACR50 alone also favored the combination (33.5% vs. 20.4%; 

Once-daily Oral Zasocitinib Demonstrates Rapid and Reproducible Skin Clearance with a Consistent Safety Profile in Moderate-to-Severe Plaque Psoriasis: Results from Two Randomized Phase 3 Trials (LATITUDE-PsO-3001 and 3002)

Takeda’s zasocitinib, an oral once-daily TYK2 inhibitor with more than one-million-fold selectivity for TYK2 over other JAK enzymes, met all primary and all 44 ranked secondary endpoints in both phase 3 LATITUDE studies (n=693 and n=1108), with superiority over placebo and apremilast. More than half of treated patients achieved PASI 90 and approximately 30% achieved PASI 100 at week 16.

 Full 24-week data will be presented for the first time at AAD 2026. Takeda plans to file an NDA in fiscal year 2026.

Povorcitinib in Patients With Moderate to Severe Hidradenitis Suppurativa: 54-Week Efficacy and Safety Results From the STOP-HS1 & STOP-HS2 Phase 3 Studies

Incyte’s povorcitinib (INCB54707), a selective oral JAK1 inhibitor, met the primary endpoint of HiSCR50 at week 12 in both phase 3 STOP-HS studies (~600 patients each), with 40.2–42.3% responding versus 28.6–29.7% on placebo.

 The 54-week dataset at AAD 2026 represents the most comprehensive durability evidence yet for any oral therapy in hidradenitis suppurativa, and is expected to support Incyte’s planned US regulatory submission in early 2026. No MACE events or deaths were observed through week 24.

Sonelokimab in moderate-to-severe HS: Long-term results through Week 40 of two Phase 3 trials

Presenter: Alexandra Boer Kimball, MD, MPH, FAAD

MoonLake Immunotherapeutics’ sonelokimab, a trivalent Nanobody targeting IL-17A and IL-17F, will present long-term data through week 40 from the VELA phase 3 program (n=838). VELA was the first phase 3 HS program to use HiSCR75 as its primary endpoint. VELA-1 met statistical significance at week 16; VELA-2 narrowly missed, attributed to an elevated placebo response.

 The week 40 data at AAD 2026 — the longest follow-up from any phase 3 HS trial — are pivotal for assessing durability and informing MoonLake’s regulatory path.

Brepocitinib Achieves Rapid and Sustained Control of Cutaneous Disease Activity, Itch, and Skin-Related Quality of Life in Dermatomyositis: Results From the Phase 3 VALOR Trial

Presenter: Ruth Ann Vleugels, MD, MBA, MPH, FAAD

Priovant Therapeutics’ brepocitinib, an oral dual TYK2/JAK1 inhibitor, is the first therapy to demonstrate efficacy in a randomized, placebo-controlled phase 3 trial in dermatomyositis. VALOR (n=241) met its primary endpoint with a mean Total Improvement Score of 46.5 versus 31.2 for placebo at week 52 (

= .0006), with all nine key secondary endpoints met and steroid-sparing effects demonstrated.

 The FDA has accepted the NDA and granted Priority Review. If approved, brepocitinib would be the first targeted therapy for dermatomyositis.

Sanofi. Sanofi’s amlitelimab confirms its potential in atopic dermatitis. GlobeNewswire. Published January 23, 2026. Accessed March 18, 2026. 

https://www.globenewswire.com/news-release/2026/01/23/3224400/0/en/Press-Release-Sanofi-s-amlitelim…

King B, Silverberg JI, Gimenez-Arnau AM, et al. Abrocitinib monotherapy in adults with chronic hand eczema (HAWK): a randomised, double-blind, placebo-controlled phase 2b trial. Lancet. 2023;401(10386):1423-1434. Accessed March 18, 2026. 

https://doi.org/10.1016/S0140-6736(23)00296-X

Alumis Inc. Alumis’ envudeucitinib delivers leading skin clearance among next-generation oral plaque psoriasis therapies in phase 3 program. BusinessWire. Published January 6, 2026. Accessed March 18, 2026. 

https://investors.alumis.com/news-releases/news-release-details/alumis-envudeucitinib-delivers-lead…

AbbVie Inc. AbbVie announces positive topline results from phase 3 pivotal studies evaluating upadacitinib (RINVOQ) in adults and adolescents with vitiligo. Published October 29, 2025. Accessed March 18, 2026. 

https://news.abbvie.com/2025-10-29-AbbVie-Announces-Positive-Topline-Results-from-Phase-3-Pivotal-S…

Eli Lilly and Company. Lilly’s Taltz (ixekizumab) and Zepbound (tirzepatide) used together demonstrated superior disease control compared to ixekizumab alone: results from the Ph3b TOGETHER-PsA trial. Published January 8, 2026. Accessed March 18, 2026. 

https://investor.lilly.com/news-releases/news-release-details/lillys-taltz-ixekizumab-and-zepbound-…

Takeda Pharmaceutical Company. Takeda’s zasocitinib delivers landmark data from two phase 3 studies in plaque psoriasis. Published December 18, 2025. Accessed March 18, 2026. 

https://www.takeda.com/newsroom/newsreleases/2025/takeda-zasocitinib-phase-3-plaque-psoriasis-data-…

Incyte Corporation. Incyte announces positive topline results from two phase 3 clinical trials of povorcitinib in patients with hidradenitis suppurativa. BusinessWire. Published March 17, 2025. Accessed March 18, 2026. 

https://www.businesswire.com/news/home/20250317947508/en/Incyte-Announces-Positive-Topline-Results-…

MoonLake Immunotherapeutics AG. MoonLake announces topline results from the VELA phase 3 program evaluating sonelokimab in hidradenitis suppurativa. GlobeNewswire. Published 2025. Accessed March 18, 2026. 

Roivant Sciences Ltd / Priovant Therapeutics Inc. Roivant and Priovant announce positive phase 3 VALOR study results for brepocitinib in dermatomyositis. GlobeNewswire. Published September 17, 2025. Accessed March 18, 2026. 

https://investor.roivant.com/news-releases/news-release-details/roivant-and-priovant-announce-posit…

Late-breaking phase 3 datasets at AAD 2026 underscore a dermatology pipeline shifting toward oral precision immunomodulators, differentiated biologic mechanisms, and expansion into underserved indications. Key readouts include anti–OX40L amlitelimab in atopic dermatitis with mixed US/EU estimand success, and new pivotal evidence for abrocitinib in chronic hand eczema. Multiple oral TYK2 programs (envudeucitinib, zasocitinib) report high PASI90/100 rates versus placebo and apremilast. Additional highlights include systemic upadacitinib for vitiligo, obesity co-therapy improving PsA control, durable HS datasets, and a first positive phase 3 dermatomyositis trial with brepocitinib.

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Podcasts

ATTD 2026 reveals AI “digital twins,” next-gen closed-loop pumps, and sensors that boost time-in-range and ease diabetes management.

Type 1 Diabetes

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Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives is a monthly podcast hosted by Diana Isaacs, PharmD, and Natalie Bellini, DNP, aimed at providing a regular roundup of the latest clinically applicable insights across diabetes and metabolic diseases, with a focus on leveraging technology to improve care.

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

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This Q&A highlights Dr. Alexa B. Kimball's responses to questions on the FDA approval of secukinumab for pediatric patients with hidradenitis suppurativa (HS).

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The MiniMed Flex is a discreet, smartphone-controlled insulin pump that is roughly the size of 2 stacked insulin vials.

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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...

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