HCPLive Editorial Staff

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include the US Food and Drug Administration (FDA) approvals of icotrokinra (Icotyde) for moderate to severe plaque psoriasis in adults and pediatric patients ≥ 12 years of age weighing ≥ 40 kg who are candidates for systemic therapy or phototherapy, a new higher dose of semaglutide (Wegovy; Wegovy HD) injection 7.2 mg for weight loss in adults with obesity, and setmelanotide (Imcivree) for acquired hypothalamic obesity in adults and pediatric patients ≥ 4 years of age, as well as phase 3 data supporting retatrutide’s use in type 2 diabetes and finerenone’s role in nondiabetic chronic kidney disease.

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of March 15, 2026—let’s jump in!

Icotrokinra, an Oral Il-23 Inhibitor, Receives FDA Approval for Psoriasis

On March 18, 2026, the FDA approved Johnson & Johnson’s icotrokinra (Icotyde) for the treatment of moderate to severe plaque psoriasis in adults and pediatric patients ≥ 12 years of age weighing ≥ 40 kg who are candidates for systemic therapy or phototherapy. The approval marks the first for an oral targeted peptide selectively blocking the IL-23 receptor and introduces a new mechanistic class to the psoriasis treatment landscape backed by data from multiple trials in the phase 3 ICONIC program.

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

On March 19, 2026, the FDA 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. The update supplements the existing semaglutide label, which also has distinct indications for semaglutide not offered by any other GLP-1 medication for weight loss.

FDA Approves Setmelanotide (Imcivree) for Acquired Hypothalmic Obesity

On March 19, 2026, the FDA approved an expanded indication for setmelanotide (Imcivree) to treat acquired hypothalamic obesity in adults and pediatric patients ≥ 4 years of age, making it the first and only FDA-approved therapy for this rare condition. The approval was based on data from the global, randomized, double-blind, placebo-controlled phase 3 TRANSCEND trial.

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

On March 19, 2026, Eli Lilly and Company 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. 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.

Finerenone Proves CKD Benefit Extends Beyond Diabetes in FIND-CKD

On March 16, 2026, Bayer announced the phase 3 FIND-CKD trial evaluating finerenone (Kerendia) in adult patients with nondiabetic chronic kidney disease met its primary endpoint, demonstrating a statistically significant improvement in eGFR slope versus placebo over 32 months. The company indicated it plans to submit the data to the FDA to seek a label expansion into this patient population, which would represent the broadest application of the agent to date across a CKD program now spanning > 20,000 patients in phase 3 trials.

Articles

Five near-term practice-shaping developments span dermatology, obesity medicine, endocrinology, and nephrology. FDA cleared icotrokinra, a first-in-class oral peptide IL‑23 receptor blocker, for moderate-to-severe plaque psoriasis in adults and adolescents meeting weight thresholds. Semaglutide received a higher 7.2 mg Wegovy HD dose option for adults with obesity after demonstrated tolerability at 2.4 mg. Setmelanotide gained the first approval for acquired hypothalamic obesity down to age 4. Retatrutide phase 3 data showed robust A1C and weight effects in type 2 diabetes. Finerenone improved eGFR slope in nondiabetic CKD, supporting label expansion.

Stay updated with the latest healthcare breakthroughs, including FDA actions and new phase 3 data, in this week’s essential news roundup.

The HCPFive: Top News for Healthcare Providers from the Week of 03/15

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include positive data from a pre-specified week 36 interim analysis of the ongoing phase 3 RAINIER trial of povetacicept in IgA nephropathy (IgAN), the US Food and Drug Administration (FDA) acceptance of a New Drug Application (NDA) for lorundrostat in hypertension, new data on weight regain after GLP-1 RA discontinuation, the FDA approval of GSK’s leucovorin calcium (Wellcovorin) tablets as the first treatment for cerebral folate deficiency, and data from the phase 3 INTEGUMENT-OLE study of once-daily roflumilast (Zoryve) cream 0.05% in children 2 to 5 years of age with mild-to-moderate atopic dermatitis.

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of March 08, 2026—let’s jump in!

RAINIER: Povetacicept Reduces Proteinuria By 52.0%

On March 9, Vertex Pharmaceuticals announced positive data from a pre-specified week 36 interim analysis of the ongoing phase 3 RAINIER trial of povetacicept, an engineered fusion protein and dual inhibitor of the BAFF and APRIL cytokines, in IgAN. Results showed patients treated with povetacicept achieved a 52% reduction from baseline in proteinuria as measured by 24-hour urine protein to creatinine ratio (UPCR) and achieved a statistically significant and clinically meaningful 49.8% reduction in UPCR versus placebo (

Lorundrostat Secures FDA NDA Acceptance for Hypertension, Falls Short in Phase 2 OSA Trial

On March 9, 2026, the FDA accepted Mineralys Therapeutics’ NDA for lorundrostat for the treatment of adult patients with hypertension in combination with other antihypertensive drugs. The NDA was based on positive data from the phase 3 Launch-HTN and phase 2 Advance-HTN trials demonstrating favorable safety and blood pressure reduction in adults with hypertension. With the acceptance, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 22, 2026.

Discontinuing GLP-1 Treatment Associated With Up to 60% Weight Regain, With Brajan Budini

Findings from a recent study suggest GLP-1RA cessation is associated with a predictable and decelerating pattern of weight regain, reaching 60% at 1 year, that plateaus below pre-treatment levels, suggesting that partial weight-loss benefit may persist long-term but is substantially attenuated.

FDA Approves Leucovorin Calcium (Wellcovorin) Tablets as First Cerebral Folate Deficiency Treatment

On March 10, 2026, the FDA approved GSK’s leucovorin calcium (Wellcovorin) tablets for the treatment of cerebral folate deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (CFD-FOLR1), making it the first treatment for the rare genetic condition of cerebral folate deficiency. The approval was based on a systematic review of the published literature on the topic, including published case reports with patient-level information, as well as mechanistic data.

New Long-Term Data Announced on Roflumilast Cream for Atopic Dermatitis in Children

On March 10, 2026, Arcutis Biotherapeutics announced that 

 published data from the phase 3 open-label extension (INTEGUMENT-OLE) study evaluating once-daily roflumilast (Zoryve) cream 0.05% in children 2 to 5 years of age with mild-to-moderate atopic dermatitis. Data from the INTEGUMENT-OLE trial, which supported the FDA approval of roflumilast cream 0.05% in October 2025, demonstrated that roflumilast cream 0.05% is safe and well-tolerated, and efficacy was not only maintained but continued to improve with up to 56 weeks of treatment.

Vertex reported week-36 interim phase 3 RAINIER data showing povetacicept (dual BAFF/APRIL inhibitor) reduced 24-hour UPCR 52% from baseline and 49.8% versus placebo (P<.0001) in IgA nephropathy. Mineralys’ lorundrostat NDA for adjunctive hypertension therapy was accepted, with a Dec 22, 2026 PDUFA date, supported by Launch-HTN and Advance-HTN results. GLP-1RA discontinuation was linked to decelerating weight regain approaching 60% at one year. FDA approved GSK’s Wellcovorin for CFD-FOLR1. Long-term INTEGUMENT-OLE data supported sustained/improving pediatric AD control with roflumilast cream to 56 weeks.

Stay updated with the latest healthcare breakthroughs, including FDA actions and new trial data, in this week’s essential news roundup.

The HCPFive: Top News for Healthcare Providers from the Week of 03/08

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include the US Food and Drug Administration acceptance of a New Drug Application for rusfertide in polycythemia vera, topline data from the phase 3 AFFIRM study of risankizumab (Skyrizi) subcutaneous induction in Crohn’s disease, phase 3 data for ralinepag in pulmonary arterial hypertension, phase 2 SUMMIT trial data on bezuclastinib in nonadvanced systemic mastocytosis, and ACTIVATE trial data on vaginal seeding in cesarean-delivered infants.

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of March 01, 2026—let’s jump in!

FDA Accepts New Drug Application for Rusfertide, Grants Priority Review In Polycythemia Vera

On March 2, 2026, the FDA accepted and granted Priority Review to an NDA for rusfertide for polycythemia vera based on results from the phase 3 VERIFY, phase 2 REVIEW, and long-term extension THRIVE study. Announced by Takeda and Protagonist, the Prescription Drug User Fee Act (PDUFA) target action date is set for the third quarter of this calendar year.

AFFIRM: Risankizumab (Skyrizi) Subcutaneous Induction Achieves Primary Endpoints in Crohn’s Disease

On March 2, 2026, AbbVie announced positive topline results from the phase 3, randomized, placebo-controlled, double-blind AFFIRM study evaluating the efficacy and safety of risankizumab (Skyrizi) subcutaneous (SC) induction treatment versus placebo in adult patients with moderately to severely active Crohn's disease. Findings showed significantly greater proportions of patients treated with risankizumab SC induction achieved the co-primary endpoints of Crohn's Disease Activity Index clinical remission and endoscopic response at week 12 compared to placebo.

ADVANCE OUTCOMES: Ralinepag Outperforms Placebo in Slowing Disease Progression in PAH

On March 2, 2026, United Therapeutics Corporation announced that its investigative prostacyclin receptor agonist ralinepag met its primary endpoint of reducing worsening clinical events in patients with pulmonary arterial hypertension in the phase 3 ADVANCE OUTCOMES study. The study additionally met several important secondary endpoints, including increasing odds of clinical improvement by 47%, in predominantly pre-treated patients with pulmonary arterial hypertension.

SUMMIT: Bezuclastinib Delivers Durable, Deepening Symptom Relief in NonAdvSM, With Cem Akin, MD

Bezuclastinib, an oral, highly selective type 1 KIT inhibitor, has demonstrated that clinically meaningful symptom improvement not only holds but continues to deepen out to 48 weeks of treatment in patients with nonadvanced systemic mastocytosis (NonAdvSM), with every assessed symptom domain showing progressive gains over the treatment course. Data from the pivotal, multicenter, randomized, double-blind, placebo-controlled phase 2 SUMMIT trial were presented at the 

American Academy of Allergy, Asthma & Immunology (AAAAI)

 2026 Annual Meeting held in Philadelphia, Pennsylvania.

Vaginal Seeding Partially Modifies Infant Microbiome in ACTIVATE, With Jose Clemente, PhD

Vaginal seeding in cesarean-delivered infants was associated with altered early gut microbiome patterns and differences in food sensitization at 12 months, according to late-breaking ACTIVATE trial data presented at the 2026 AAAAI Annual Meeting in Philadelphia. Jose Clemente, PhD, associate professor of Genetics and Genomics and Immunology at the Icahn School of Medicine at Mount Sinai, explains the biologic rationale behind the trial and what the findings may mean for clinicians.

FDA granted Priority Review for rusfertide in polycythemia vera, with an NDA supported by phase 3/2 and extension datasets and a PDUFA decision targeted for Q3. In Crohn’s disease, subcutaneous risankizumab induction met co-primary endpoints at week 12, demonstrating clinical remission and endoscopic response versus placebo. In pulmonary arterial hypertension, ralinepag reduced worsening clinical events and improved odds of clinical improvement in largely pre-treated patients. Bezuclastinib showed durable, deepening symptom benefit through 48 weeks in nonadvanced systemic mastocytosis. Vaginal seeding modestly shifted infant microbiome trajectories and food sensitization signals.

Stay updated with the latest healthcare breakthroughs, FDA actions, and new trial data, in this week’s essential news roundup.

The HCPFive: Top News for Healthcare Providers from the Week of 03/01

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include phase 3 data for obinutuzumab in primary membranous nephropathy as well as ixekizumab and tirzepatide in moderate-to-severe plaque psoriasis and obesity or overweight with ≥ 1 additional weight-related comorbid condition, new data supporting the cardiovascular benefits of AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted), findings from a second phase 3 trial evaluating COMP360 in treatment-resistant depression, and preclinical data for Thykamine™ in a human metabolic-associated steatohepatitis (MASH) model using PhysioMimix® Liver-on-a-Chip platform.

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of February 15, 2026—let’s jump in!

MAJESTY: Obinutuzumab Achieves 2 Year Complete Remission in Primary Membranous Nephropathy

On February 16, 2026, Genentech, a member of the Roche Group, announced that the phase 3 MAJESTY study in adults with primary membranous nephropathy met its primary endpoint, showing statistically significant and clinically meaningful results with obinutuzumab (Gazyva).

In the study, significantly more people achieved complete remission at 2 years (104 weeks) with obinutuzumab versus tacrolimus, with no new safety signals identified. Genentech described plans to present the data at an upcoming medical meeting and share it with health authorities, including the US Food and Drug Administration.

Ixekizumab, Tirzepatide Effective Together for Psoriasis and Obesity or Overweight

On February 19, 2026, Eli Lilly and Company announced positive topline results from the landmark TOGETHER-PsO open-label phase 3b clinical trial evaluating the concomitant use of ixekizumab (Taltz) and tirzepatide (Zepbound) compared to ixekizumab alone in adults with moderate-to-severe plaque psoriasis and obesity or overweight with ≥ 1 additional weight-related comorbid condition.

Results showed that at 36 weeks, treatment with ixekizumab and tirzepatide met the primary and all key secondary endpoints, delivering superior skin clearance and weight loss versus ixekizumab monotherapy.

AREXVY Vaccine Reduces Hospitalization, Major Adverse Cardiovascular Events in RSV

On February 18, 2026, GSK announced new effectiveness data for AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) at RSVVW’26, the 9th Conference of the Respiratory Syncytial Virus Foundation (ReSViNET) in Rome, Italy.

This retrospective cohort study included >2.5 million patients, of whom 520,440 were vaccinated and matched in a 1:4 ratio to 2,081,760 patients who did not receive the vaccine. Results showed the vaccine was associated with 75.6% effectiveness against RSV-related hospitalization at a median follow-up period of 5.6 months post-vaccination. Additional exploratory endpoints indicated 63.1% vaccine effectiveness against major adverse cardiovascular events, including heart attack and stroke, during hospitalization among patients aged ≥60 years.

COMP360 Psilocybin Meets Primary Endpoint in Second Phase 3 Trial for TRD

On February 17, 2026, Compass Pathways announced that its investigational synthetic psilocybin formulation, COMP360, met the primary endpoint in the second pivotal phase 3 trial evaluating the therapy in adults with treatment-resistant depression.

In the COMP006 study, a pair of 25-mg doses administered 3 weeks apart produced a statistically significant reduction in depressive symptom severity at week 6 compared with a 1-mg dose control, reinforcing findings from the companion COMP005 trial and advancing the program toward regulatory submission.

Thykamine Shows Disease-Modifying Potential in MASH Using Liver-on-a-Chip Platform

On February 19, 2026, Devonian Health Group announced positive results from a follow-up preclinical study evaluating Thykamine™ in a human metabolic-associated steatohepatitis (MASH) model using PhysioMimix® Liver-on-a-Chip platform. The study was conducted by CN Bio Innovations, Cambridge, UK. The study demonstrates that Thykamine™ exerts dose-dependent effects on key pathological hallmarks of MASH, including fibrosis and inflammation, in a physiologically relevant human liver system, representing a notable translational bridge between Devonian’s previously disclosed efficacy in the mouse STAM® MASH model and a predictive human microphysiological model.

Phase 3 MAJESTY data showed obinutuzumab achieved higher 104-week complete remission rates than tacrolimus in primary membranous nephropathy, without new safety signals, supporting regulatory engagement. In TOGETHER-PsO, concomitant ixekizumab plus tirzepatide outperformed ixekizumab alone for skin clearance and weight loss in patients with plaque psoriasis and obesity/overweight with comorbidities. Real-world effectiveness data linked AREXVY to fewer RSV hospitalizations and exploratory reductions in in-hospital MACE. COMP360 synthetic psilocybin met a second pivotal TRD endpoint. Thykamine demonstrated dose-dependent anti-fibrotic and anti-inflammatory effects in a human Liver-on-a-Chip MASH model.