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 spotlight data from 

, including 4-year LUCENT-3 extension results showing durable disease clearance with mirikizumab in ulcerative colitis and phase 3 FUZION data establishing guselkumab as the first biologic to demonstrate efficacy in perianal fistulizing Crohn's disease in 2 decades, We also highlight new data on abrocitinib, a deep dive into the patient education gap in hypertension risk detection and management, and a Skin of Color Savvy discussion with Noreen Galaria, MD, on misinformation, holistic dermatology, and caring for patients with skin of color.

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 May 3, 2026 — let's jump in!

Abrocitinib Therapy Effective in Patients With Atopic Dermatitis at 2 Years

An interim analysis of the phase 3 JADE EXTEND long-term extension trial found that dose-dependent clinician-reported efficacy measures continued to improve through 2 years of oral abrocitinib use in adolescent and adult patients with moderate-to-severe atopic dermatitis who had previously completed qualifying trials. Patient-reported outcomes — including itch reduction and quality of life measures — complemented the clinical findings, with investigators noting that a substantial proportion of patients achieved high-threshold endpoints and minimal disease activity at 2 years.

Mirikizumab Maintains Disease Clearance in UC Through 4 Years in LUCENT-3 Extension

Final data from the LUCENT-3 open-label extension study, presented at DDW 2026, showed that 63.5% of patients with moderately to severely active ulcerative colitis who achieved disease clearance — a composite requiring simultaneous symptomatic, endoscopic, and histologic remission — at 1 year maintained it through 4 years of continuous mirikizumab treatment on an observed-cases basis. The findings mark the first demonstration of durable disease clearance at 4 years for any IL-23p19 inhibitor in UC, and Lilly reported that during the 3-year extension period only 1 UC-related hospitalization and 0 UC-related surgeries occurred among treated patients.

Guselkumab Shows Efficacy in Perianal Fistulizing Crohn's Disease in Phase 3 FUZION Trial

Presented as late-breaking data at DDW 2026, the phase 3 FUZION trial found that guselkumab (Tremfya; Johnson & Johnson) achieved combined fistula remission — defined as complete external closure of all draining fistulas with no underlying fluid collection on MRI — in approximately 28% of patients with active perianal fistulizing Crohn's disease at week 24 versus just over 10% on placebo, a treatment difference exceeding 15 percentage points. The result represents the first randomized controlled trial of an approved IBD therapy to demonstrate efficacy in perianal fistulizing Crohn's disease in approximately 20 years, addressing a longstanding evidence gap in one of the most disabling manifestations of the disease.

Filling the Gaps: Educating Patients in Hypertension Risk, Detection, and Management

Despite the availability of effective antihypertensive therapies, only 2 in 3 US adults with hypertension receive treatment — a rate that has not improved from 2009–2010 to 2021–2023 — and among those treated, roughly 4 in 5 remain above the guideline-directed blood pressure goal of <130/80 mmHg. Evidence reviewed in this piece suggests targeted patient education interventions, including tailored messaging from kiosk-based screening programs and home blood pressure monitoring, are associated with improved adherence, lower mean systolic blood pressure, and higher rates of control, pointing to patient education as an underutilized lever in narrowing the treatment-to-control gap.

Skin of Color Savvy: Misinformation, Holistic Dermatology, and Skin of Color, With Noreen Galaria, MD

In this episode of the Skin of Color Savvy podcast, produced in partnership with the Skin of Color Society, Noreen Galaria, MD, discussed the growing challenge of social media–driven misinformation in dermatology, the integration of nutraceuticals and antioxidant-based strategies into conventional skin care, and the clinical importance of ensuring adequate representation in dermatologic training and practice. Galaria also addressed physician wellness, emphasizing sustainable self-care practices and the value of interdisciplinary collaboration — including dermatologists' role in identifying systemic disease — as part of a broader shift toward holistic, patient-centered dermatologic care.

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Therapeutic and practice advances span immunology, IBD, cardiometabolic care, and dermatology. Two-year JADE EXTEND interim results showed sustained, dose-dependent improvements with oral abrocitinib in moderate-to-severe atopic dermatitis, supported by patient-reported itch and quality-of-life gains. In ulcerative colitis, four-year LUCENT-3 data demonstrated durable composite disease clearance with mirikizumab and very low UC-related hospitalization/surgery during extension. Phase 3 FUZION established guselkumab efficacy in perianal fistulizing Crohn’s disease, addressing a decades-long evidence gap. Patient education emerged as a key lever to close hypertension control deficits amid misinformation challenges in skin-of-color care.

Stay updated with the latest healthcare breakthroughs, including data from DDW and a new podcast episode.

The HCPFive: Top News for Healthcare Providers from the Week of 05/03

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 anifrolumab-fnia (Saphnelo) for subcutaneous self-administration in systemic lupus erythematosus (SLE) and lumateperone (Caplyta) for schizophrenia, clearance of Tandem Diabetes Care’s Control-IQ+ automated insulin delivery technology for use during pregnancy complicated by type 1 diabetes, Priority Review and Breakthrough Therapy Designation for bepirovirsen in chronic hepatitis B, and approval of AstraZeneza’s budesonide/glycopyrrolate/formoterol fumarate (BGF; BREZTRI Aerosphere) as the first single-inhaler triple-combination maintenance therapy for asthma in adult and pediatric patients 12 years of age and older.

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 April 26, 2026—let’s jump in!

Anifrolumab (Saphnelo) Wins FDA Approval for Subcutaneous Self-Administration in SLE

On April 27, 2026, the FDA approved anifrolumab-fnia (Saphnelo) for subcutaneous self-administration via a once-weekly 120 mg autoinjector, the Saphnelo Pen, for adult patients with moderate to severe SLE receiving standard therapy. The decision was based on results from the phase 3 TULIP-SC trial.

Lumateperone sNDA Approved with Relapse Prevention Data in Schizophrenia

On April 26, 2026, the FDA approved a supplemental New Drug Application (sNDA) for lumateperone (Caplyta) based on long-term data supporting the prevention of relapse in adults with schizophrenia. Specifically, a phase 3 randomized withdrawal trial demonstrating a 63% reduction in relapse risk versus placebo over a 26-week double-blind treatment period.

FDA Clears Control-IQ+ for Use in Pregnancy With Type 1 Diabetes

On April 27, 2026, the FDA cleared Tandem Diabetes Care’s Control-IQ+ automated insulin delivery technology for use during pregnancy complicated by type 1 diabetes, expanding the label for the company’s t:slim X2 and Tandem Mobi systems. According to the Company, this makes Control-IQ+ the first commercially available automated insulin delivery system in the US with a pregnancy indication.

FDA Grants Bepirovirsen Breakthrough Therapy Designation, Priority Review for Chronic Hepatitis B

On April 28, 2026, the FDA accepted for Priority Review the New Drug Application (NDA) for bepirovirsen, an investigational antisense oligonucleotide developed by GSK in partnership with Ionis Pharmaceuticals, for the treatment of adults with chronic hepatitis B. The Agency simultaneously granted bepirovirsen Breakthrough Therapy designation and established a PDUFA target action date of October 26, 2026.

If approved, bepirovirsen would represent the first therapy to achieve clinically meaningful functional cure rates in this population, addressing a significant gap in the current treatment landscape.

FDA Approves BGF Triple Therapy for Asthma in Patients 12 and Older

On April 28, 2026, the FDA approved AstraZeneza’s budesonide/glycopyrrolate/formoterol fumarate (BGF; BREZTRI Aerosphere) as the first single-inhaler triple-combination maintenance therapy for asthma in adult and pediatric patients 12 years of age and older. The decision marks the second approved indication for BGF, which received FDA clearance for chronic obstructive pulmonary disease in adults in 2020.

Multiple late-April 2026 FDA actions expanded access to therapies and devices across immunology, psychiatry, diabetes, virology, and pulmonary medicine. Anifrolumab gained a once-weekly subcutaneous autoinjector option for moderate-to-severe SLE based on phase 3 TULIP-SC. Lumateperone received an sNDA approval supported by phase 3 randomized withdrawal data showing reduced schizophrenia relapse risk. Tandem’s Control-IQ+ was cleared for type 1 diabetes in pregnancy. Bepirovirsen received Priority Review and Breakthrough Therapy designation in chronic hepatitis B, and BGF triple therapy was approved for asthma ages ≥12.

Stay updated with the latest healthcare breakthroughs, including notable FDA approvals and filings, in this week’s essential news roundup.

The HCPFive: Top News for Healthcare Providers from the Week of 04/26

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 a prespecified interim analysis of the phase 3 I-CAN trial showing ravulizumab reduced proteinuria in IgA nephropathy as early as week 10, 52-week REZOLVE-AA extension data demonstrating deepening hair regrowth responses with rezpegaldesleukin in severe alopecia areata, a third consecutive positive phase 3 readout for tozorakimab in COPD from the MIRANDA trial, topline results from the phase 3 HIBISCUS trial showing etavopivat met both co-primary endpoints in sickle cell disease, and FDA accelerated approval of lunsotogene parvec-cwha (Otarmeni) as the first gene therapy for OTOF-related genetic hearing loss.

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 April 19, 2026 — let's jump in!

Ravulizumab Reduces Proteinuria as Early as Week 10 in Phase 3 I-CAN Trial for IgAN

A prespecified interim analysis of the phase 3 I-CAN trial found that ravulizumab (Ultomiris), a long-acting C5 complement inhibitor administered intravenously every 8 weeks, met its primary endpoint of statistically significant and clinically meaningful proteinuria reduction based on 24-hour urine protein creatinine ratio at week 34, with rapid effects observed as early as week 10, in adults with IgA nephropathy at risk of progression. Alexion/AstraZeneca plans to seek accelerated approval in key markets while the trial continues to its week 106 eGFR endpoint, with full data to be presented at a forthcoming medical meeting.

REZOLVE-AA: 52-Week Data Highlight Positive Alopecia Areata Outcomes With Rezpegaldesleukin

New data from the blinded 16-week extension of the phase 2b REZOLVE-AA study, announced April 20, showed that 29% to 31% of patients in the low- and high-dose rezpegaldesleukin arms who had not yet reached a SALT ≤20 response by week 36 achieved new responses during the extension, with SALT ≤20 rates across the full study population reaching 25.8% and 27.6% in the low- and high-dose groups, respectively, versus 6.7% with placebo at 52 weeks. Rezpegaldesleukin, a first-in-class IL-2 pathway agonist designed to selectively expand regulatory T cells, was well tolerated through 52 weeks, with 94% of extension patients completing treatment and no discontinuations due to adverse events, supporting Nektar's plans to advance the drug into phase 3 development in severe alopecia areata.

Phase 3 MIRANDA: Tozorakimab Reduces COPD Exacerbations

AstraZeneca announced April 20 that tozorakimab met its primary endpoint in the phase 3 MIRANDA trial, demonstrating statistically significant and clinically meaningful reductions in moderate-to-severe COPD exacerbations compared with placebo in former smokers and in the overall population — including current smokers across all eosinophil levels and lung function severity stages — with patients receiving 300 mg every 2 weeks rather than the 4-week interval used in OBERON and TITANIA. The result marks the third consecutive positive phase 3 readout in the LUNA program, further establishing tozorakimab as a potential first-in-class IL-33–targeting biologic for COPD independent of eosinophil-driven disease subtypes; full numeric data remain pending presentation at a medical meeting.

Phase 3 HIBISCUS: Etavopivat Cuts VOC Events, Improves Hemoglobin in SCD

Topline results from the phase 3 HIBISCUS trial, announced April 20, showed that once-daily oral etavopivat 400 mg — an investigational pyruvate kinase-R activator — reduced vaso-occlusive crisis events by 27% and delayed time to first crisis to 38.4 weeks versus 20.9 weeks on placebo, while 48.7% of treated patients achieved a hemoglobin increase of more than 1 g/dL at week 24 compared with 7.2% on placebo. Etavopivat, which holds Fast Track, Rare Pediatric Disease, and Orphan Drug designations in the US, met both co-primary endpoints in 385 patients aged 12 years and older with sickle cell disease on background standard of care, and Novo Nordisk plans to file for initial regulatory approval in the second half of 2026.

FDA Approves Lunsotogene Parvec for OTOF-Related Genetic Hearing Loss

The FDA granted accelerated approval on April 23 to lunsotogene parvec-cwha (Otarmeni; Regeneron), the first gene therapy for OTOF-related hearing loss and the first approved gene therapy to restore a neurosensory function, based on phase 1/2 CHORD trial data in which 80% of 20 evaluable pediatric patients achieved a primary hearing threshold endpoint at 24 weeks, with 42% reaching normal hearing thresholds at 48 weeks. The single-dose AAV vector therapy is delivered via intracochlear infusion under general anesthesia and indicated for patients with molecularly confirmed biallelic OTOF variants, preserved outer hair cell function, and no prior cochlear implant in the treated ear; Regeneron announced the drug will be provided at no cost to eligible US patients, though procedure-related costs may still apply.

Five late-stage updates span complement inhibition, immune modulation, cytokine blockade, erythrocyte metabolism, and inner-ear gene replacement. Ravulizumab achieved rapid, clinically meaningful proteinuria reduction in IgA nephropathy, enabling accelerated-approval plans ahead of eGFR readout. Rezpegaldesleukin produced deepening SALT ≤20 responses through 52 weeks with favorable tolerability, supporting phase 3. Tozorakimab reduced COPD exacerbations across smoking status and eosinophil strata. Etavopivat lowered VOC burden and improved hemoglobin in sickle cell disease. FDA accelerated approval granted to lunsotogene parvec for OTOF-related pediatric deafness.

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

The HCPFive: Top News for Healthcare Providers from the Week of 04/19

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) approval of sparsentan (Filspari) for the treatment of 

focal segmental glomerulosclerosis (FSGS)

, positive topline phase 2 data for SPY001 in 

, the FDA acceptance of a supplemental New Drug Application (sNDA) for delgocitinib (Anzupgo) cream for the treatment of moderate-to-severe chronic hand eczema in adolescents aged 12 to 17 years, the discontinuation of Insmed Incorporated’s brensocatib development program in 

, and the tentative FDA approval of a generic semaglutide injection submitted by Apotex Corp.

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 April 12, 2026—let’s jump in!

FDA Approves Sparsentan for Focal Segmental Glomerulosclerosis

On April 13, 2026, the FDA granted full approval to Travere Therapeutics’ sparsentan (Filspari) for the treatment of FSGS, supported by data from 2 of the largest head-to-head interventional studies in adult and pediatric patients with FSGS, the phase 3 DUPLEX study and the phase 2 DUET study. The decision makes sparsentan the first and only drug approved for this indication.

SPY001, An Anti-α4β7, Shows Promise in Phase 2 SKYLINE Trial for Ulcerative Colitis

On April 13, 2026, Spyre Therapeutics announced positive 12-week induction data from Part A of the phase 2 SKYLINE trial of SPY001, a potential best-in-class anti-α4β7 being investigated for the treatment of moderate-to-severely active UC. The Company additionally announced that recruitment for Part A of SKYLINE is now closed and enrollment is open for Part B, which includes 3 monotherapy cohorts (SPY001, SPY002, and SPY003) and 3 combination cohorts (SPY120, SPY130, and SPY230) into which participants may be randomized versus a shared placebo. Proof-of-concept induction data for the remaining cohorts of Part A are now expected mid-2026 (SPY002) and Q3 2026 (SPY003), while Part B induction data for all cohorts remain on track for 2027.

FDA Accepts Delgocitinib sNDA for Chronic Hand Eczema in Adolescents Aged 12–17

On April 15, 2026, the FDA accepted an sNDA for delgocitinib (Anzupgo) cream for the treatment of moderate-to-severe chronic hand eczema in adolescents aged 12 to 17 years. The filing acceptance marks the first regulatory review pathway in the United States specifically targeting the pediatric age group for chronic hand eczema and comes less than 1 year after delgocitinib cream became the first therapy to receive FDA approval for chronic hand eczema in adults in July 2025.

Brensocatib Phase 2b Study in HS Does Not Meet Endpoints, Program Discontinued

Insmed Incorporated announced that the phase 2b CEDAR study evaluating brensocatib in adult patients with moderate to severe hidradenitis suppurativa did not meet its primary or secondary efficacy endpoints in either the 10 mg or 40 mg treatment arms. Based on these data, Insmed indicated plans to discontinue its development program of brensocatib in this disease state and to present these data at a future congress.

FDA Gives Tentative Approval of ANDA for Generic Semaglutide Injection

The FDA announced its tentative approval of an Abbreviated New Drug Application (ANDA) for a generic semaglutide injection submitted by Apotex Corp. The decision marks a regulatory step toward potential generic competition in the GLP-1 RA class. However, the approval does not permit immediate marketing but indicates that the application meets FDA standards for quality, safety, and efficacy, pending resolution of patent or exclusivity barriers.

FDA actions and readouts this week spanned nephrology, immunology, dermatology, and metabolic therapeutics. Sparsentan received full approval as the first indicated therapy for focal segmental glomerulosclerosis, supported by phase 3 DUPLEX and phase 2 DUET data. Spyre reported positive induction results for SPY001 in moderate-to-severe ulcerative colitis and moved into monotherapy and combination cohorts. FDA accepted an adolescent sNDA for topical delgocitinib in chronic hand eczema, while Insmed halted brensocatib in hidradenitis suppurativa after a negative phase 2b CEDAR study. Apotex received tentative ANDA approval for generic semaglutide.