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 accepted for Priority Review the New Drug Application (NDA) for bepirovirsen, an investigational antisense oligonucleotide (ASO) developed by GSK in partnership with Ionis Pharmaceuticals, for the treatment of adults with 

The Agency has 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.

"Over one million people in the U.S. are living with chronic hepatitis B and as of today, require lifelong antiviral therapy to suppress the virus," Brett Monia, PhD, chief executive officer of Ionis Pharmaceuticals, said in a statement. "As the first medicine to deliver clinically meaningful functional cure rates, bepirovirsen is uniquely positioned to effectively treat CHB based on its potential to reduce the replication of hepatitis B virus, suppress hepatitis B surface antigen and stimulate the immune system."

The NDA is supported by results from a pair of global phase 3 trials: B-Well 1  and B-Well 2. Both were multicenter, randomized, double-blind, placebo-controlled trials conducted across 29 countries. Enrolled participants were adults with CHB who were receiving nucleos(t)ide analogue (NA) therapy and had baseline hepatitis B surface antigen (HBsAg) levels of ≤3000 IU/mL.

The primary endpoint was the proportion of participants achieving functional cure, defined as undetectable HBsAg in blood for at least 24 weeks after cessation of all treatment, in the population with baseline HBsAg ≤3000 IU/mL. A key secondary endpoint assessed functional cure in patients with baseline HBsAg ≤1000 IU/mL. 

According to the press release, bepirovirsen plus standard of care demonstrated statistically significant and clinically meaningful functional cure rates across all ranked endpoints compared to standard of care alone, with a more pronounced effect observed in patients with lower baseline HBsAg levels. The safety and tolerability profile was described as acceptable and consistent with prior studies. 

Full data are expected to be presented at the European Association for the Study of the Liver (EASL) 2026 Congress in May 2026, with simultaneous peer-reviewed publication anticipated.

Bepirovirsen previously received Fast Track designation from the FDA in February 2024.

CHB is a major global public health burden, affecting an estimated 254 million people worldwide and causing approximately 1.1 million deaths annually, primarily from cirrhosis and hepatocellular carcinoma.² Current standard-of-care therapy with NAs effectively suppresses viral replication but rarely eliminates infection; functional cure rates with existing regimens are estimated at approximately 1% per year.

Because functional cure is associated with meaningful reduction in long-term hepatic complications, including liver cancer, it is considered the paramount therapeutic goal in CHB management, but current treatments rarely achieve it.

Bepirovirsen is an ASO designed to target and degrade HBV-derived RNA transcripts, thereby reducing production of viral proteins including HBsAg and hepatitis B e antigen. By suppressing HBsAg, the drug may relieve HBsAg-mediated immune tolerance, potentially enabling durable immune-mediated control of infection. This multi-pronged mechanism with direct viral RNA degradation and immunostimulatory effects distinguishes bepirovirsen from NA therapies, which suppress HBV DNA replication without meaningfully lowering HBsAg.

GSK licensed bepirovirsen from Ionis in 2019. The drug is currently under parallel regulatory review by the European Medicines Agency, China's National Medical Products Administration, and Japan's Ministry of Health, Labour and Welfare. It has received Breakthrough Therapy designation in China and SENKU designation in Japan.

BusinessWire/Ionis Pharmaceuticals. Ionis partner GSK announces bepirovirsen accepted for Priority Review and granted Breakthrough Therapy Designation by U.S. FDA as a potential first-in-class medicine for chronic hepatitis B. Published April 28, 2026. 

https://www.businesswire.com/news/home/20260427721143/en/Ionis-partner-GSK-announces-bepirovirsen-accepted-for-Priority-Review-and-granted-Breakthrough-Therapy-Designation-by-U.S.-FDA-as-a-potential-first-in-class-medicine-for-chronic-hepatitis-B

Brooks A. FDA Grants Fast Track Designation for Bepirovirsen for Chronic Hepatitis B. HCPLive. February 13, 2024. Accessed April 28, 2026. 

https://www.hcplive.com/view/fda-grants-fast-track-designation-for-bepirovirsen-for-chronic-hepatitis-b

Razavi-Shearer D, Gamkrelidze I, Nguyen MH, et al. Global prevalence, treatment, and prevention of hepatitis B virus infection in 2016: a modelling study. 

Terrault NA, Lok ASF, McMahon BJ, et al. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. 

Articles

The FDA granted Priority Review and Breakthrough Therapy designation to the NDA for bepirovirsen, an investigational antisense oligonucleotide for adults with chronic hepatitis B receiving nucleos(t)ide analogue therapy, with a PDUFA date of October 26, 2026. Phase 3 B-Well 1 and B-Well 2 trials across 29 countries met ranked endpoints for functional cure, defined by sustained HBsAg loss after treatment cessation, with greater benefit in lower baseline HBsAg strata. The mechanism combines HBV RNA transcript degradation, HBsAg suppression, and potential immune reactivation.

The FDA has accepted bepirovirsen's NDA for Priority Review and granted Breakthrough Therapy designation, with a PDUFA date of October 26, 2026.

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

OBERON and TITANIA Showcase Tozorakimab's Emerging Benefit for COPD, With Frank Sciurba, MD

The investigational IL-33 inhibitor tozorakimab (AstraZeneca) produced statistically significant and clinically meaningful reductions in annualized moderate-to-severe exacerbation rates in people with chronic obstructive pulmonary disease (COPD) in both phase 3 OBERON and TITANIA trials, with efficacy extending across all blood eosinophil levels and both former and current smokers.

spoke with Frank C. Sciurba, MD, chief investigator of the LUNA program, about the news as announced by AstraZeneca. Sciurba, tenured professor of medicine and director of the Emphysema COPD Research Center at the University of Pittsburgh School of Medicine, described the findings as indicative of broad potential applicability in a disease where current biologics serve a narrow patient subset.

OBERON and TITANIA were identically designed, randomized, double-blind, placebo-controlled phase 3 trials enrolling a combined 2,306 adults with COPD, randomized to tozorakimab 300 mg subcutaneously every 4 weeks or placebo for 52 weeks on a background of standard-of-care inhaled maintenance therapy. Both trials targeted a frequent exacerbator population — the same enrichment strategy applied across most contemporary COPD biologic development programs — and enrolled patients without restriction on blood eosinophil count, including both former and current smokers. The primary endpoint in both studies was the annualized rate of moderate-to-severe COPD exacerbations in the primary population of former smokers, with the overall population of former and current smokers together assessed as a key secondary population.

Sciurba explained that the decision to enroll current smokers alongside former smokers was deliberate and clinically meaningful. Prior signals from agents targeting the IL-33 pathway had raised questions about whether active smoking might attenuate efficacy — a consideration given that cigarette smoke can modulate epithelial IL-33 release and downstream signaling. By prospectively enrolling both populations, OBERON and TITANIA were positioned to assess this question directly. The results, as reported in the press release, showed benefit in both the primary former-smoker population and the combined population including current smokers, suggesting that smoking status did not substantially limit treatment effect. Similarly, the inclusion of patients across all blood eosinophil categories — a deliberate departure from the enrichment strategies used in the COPD approval programs for dupilumab and IL-5 inhibitors — was intended to characterize tozorakimab's utility in the low-eosinophil majority, which represents approximately 70% of COPD patients and currently has no approved biologic option. The press release confirmed efficacy across all eosinophil levels, consistent with the mechanistic rationale that IL-33 sits upstream of both Th2 and Th1/Th17 inflammatory pathways.

Sciurba was careful to note that the full results — including subgroup analyses, secondary endpoint data covering symptoms, lung function, and quality of life, and complete safety characterization — remain to be presented at a forthcoming scientific meeting and have not yet been disclosed. He expressed confidence that the magnitude of benefit reported would be viewed as clinically, not just statistically, meaningful by COPD specialists, and that the breadth of the effect across subgroups positions tozorakimab as potentially complementary to rather than simply competitive with existing agents.

Two additional studies under the broader LUNA program will provide further data in the near term. PROSPERO, a long-term extension enrolling completers from OBERON and TITANIA, will assess outcomes including severe exacerbations — events that are less frequent than moderate exacerbations and require extended follow-up to accrue adequate numbers — over an additional year of observation. MIRANDA is evaluating a more frequent dosing regimen of tozorakimab every 2 weeks, compared with the every-4-week schedule used in OBERON and TITANIA, to determine whether dosing intensity affects primary and secondary outcomes. Sciurba also noted that, should tozorakimab reach approval, the field will face the productive challenge of positioning multiple mechanistically distinct COPD biologics relative to one another. He expressed hope for head-to-head comparative trials in the longer term, while acknowledging that near-term priority lies in presenting and debating the full dataset with the specialist community.

“I'm super excited to be in the box seats on this and and then to you know, work with our community to decide [tozorakimab’s] position in the treatment regimen of COPD,” Sciurba said.

Sciurba has reported disclosures including AstraZeneca, COPD Foundation, Gala Therapeutics, GlaxoSmithKline, National Institute of Health, Nuvaira, Patient-Centered Outcomes Research Institute, Pulmonx Corporation, Sano, U.S. Department of Defense, University of Pittsburgh, and Verona Pharma.

AstraZeneca. Tozorakimab met primary endpoint in both OBERON and TITANIA phase III trials in patients with COPD. Press release. March 27, 2026. Accessed March 27, 2026. 

https://www.businesswire.com/news/home/20260327464200/en/Tozorakimab-met-primary-endpoint-in-both-OBERON-and-TITANIA-Phase-III-trials-in-patients-with-COPD

Videos

The phase 3 trials enrolled frequent exacerbators regardless of eosinophil count or smoking status.

COPD

COPD condition center page, resources on the topics of medical news and expert insight into chronic obstructive pulmonary disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on COPD research, treatment, and drug development.

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Infectious Disease condition center page is a comprehensive resource for clinical news and insights on respiratory health. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for asthma, COPD, interstitial lung disease, COVID-19, and more.

Aleena Banerji, MD, professor at Harvard Medical School and director of clinical care at the Center for Drug and Vaccine Allergy at Massachusetts General Hospital.

Single-Dose Lonvo-z Cuts HAE Attacks by 87% in Phase 3 Trial, With Aleena Banerji, MD

A single dose of lonvoguran ziclumeran (lonvo-z) reduced 

 attack rates by 87% compared with placebo in the phase 3 HAELO trial, Intellia Therapeutics shared on April 27, 2026.

, lead investigator Aleena Banerji, MD, professor at Harvard Medical School and director of clinical care at the Center for Drug and Vaccine Allergy at Massachusetts General Hospital, highlighted the efficacy and safety of lonvoguran ziclumeran for HAE observed over 6 months. Lonvoguran ziclumeran, an in vivo CRISPR-based gene editing therapy, uses CRISPR/Cas9 technology to target and inactivate the KLKB1 gene in hepatocytes, reducing kallikrein production and downstream bradykinin generation.

Patients receiving lonvoguran ziclumeran achieved a mean monthly attack rate of 0.26 compared with 2.10 in the placebo arm (

 <.0001). Furthermore, a substantial proportion of patients became both attack-free and free from long-term prophylaxis (62% vs 11% on placebo; 

“The biggest benefit that we're seeing here is a one-time treatment that is leading to a significant reduction in attacks similar to the other long-term prophylactic treatments, except that this one does not require any ongoing long-term treatment,” Banerji said.

Safety findings to date have been consistent with earlier studies, with no serious adverse events reported during the primary observation period. Common adverse events, all mild to moderate, included infusion-related reactions, headache, and fatigue. Banerji addressed the need for continued follow-up to monitor for delayed risks associated with in vivo CRISPR gene editing.

The trial design required discontinuation of baseline prophylaxis before treatment, which Banerji described as a “higher bar to meet” to demonstrate efficacy. Despite this, lonvoguran ziclumeran achieved significant reductions in attack rates, supporting its potential effectiveness in real-world settings.

Banerji noted that all patients with HAE are candidates for prophylaxis, and shared decision-making will guide adoption if approved. She added that ongoing follow-up, including multi-year safety and efficacy data, will be critical in defining the therapy’s role.

“[Lonvoguran ziclumeran is a] really exciting advance for our patients with hereditary angioedema,” she said. “We have 11 available treatments in the United States, 6 of them for long-term prophylaxis, and so this certainly adds another novel treatment option for prevention of attacks. It moves the needle quite a bit for our patients with hereditary angioedema as a one-time treatment with a significantly high rate of efficacy and very good safety data.”

Intellia Therapeutics has begun a rolling biologics license application (BLA) submission, which is expected to be completed in the second half of 2026, with a potential US launch in 2027 if approval is granted.

Derman C. Single-Dose Lonvoguran Ziclumeran Cuts HAE Attacks by 87% in Phase 3 Trial. HCPLive. Published April 27, 2026. Accessed April 27, 2026. 

https://www.hcplive.com/view/single-dose-lonvoguran-ziclumeran-cuts-hae-attacks-87-phase-3-trial

Intellia Therapeutics. Intellia Therapeutics reports positive phase 3 results in hereditary angioedema, marking a global first for in vivo gene editing. April 27, 2026. 

https://ir.intelliatx.com/news-releases/news-release-details/intellia-therapeutics-reports-positive-phase-3-results

Intellia Therapeutics Initiates Rolling Submission of Biologics License Application to FDA for Lonvoguran Ziclumeran (lonvo-z) as a One-Time Treatment for Hereditary Angioedema - Intellia Therapeutics. Intellia Therapeutics. Published on April 27, 2026. Accessed April 27, 2026. 

https://ir.intelliatx.com/news-releases/news-release-details/intellia-therapeutics-initiates-rolling-submission-biologics

Phase 3 HAELO data show an 87% reduction in hereditary angioedema attack rates with a one-time CRISPR therapy. Banerji discusses efficacy, safety, and durability.

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.

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 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.

Hematology

Sickle Cell

Sickle Cell condition center page, resources on the topics of medical news and expert insight into sickle cell disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on sickle cell research, treatment, and drug development.

Alopecia

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

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.

Credit: Yale University School of Medicine

Oruka Therapeutics has announced encouraging interim findings from the EVERLAST-A phase 2a trial assessing ORKA-001 in individuals with 

, with clearance rates favorably comparable to currently available agents.

This study evaluating ORKA-001, an investigational half-life extended IL-23p19 monoclonal antibody, looket at patients with plaque psoriasis, a chronic, common, inflammatory skin condition often characterized by significant itch and lesions described as sharply scaly, demarcated, and erythematous plaques.

Patients with the disease were assessed in EVERLAST-A, a randomized, double-blind, placebo-controlled study.

“These data with ORKA-001 are highly compelling,” Bruce Strober, MD, PhD, clinical professor of dermatology at Yale University School of Medicine and lead investigator for EVERLAST-A, said in a statement.

 “If this type of efficacy and safety profile could be available with dosing once to twice per year, it would represent a major step forward for the field. I could envision this being the preferred product for any patient with moderate-to-severe psoriasis.”

The study was conducted within both the US and Canada across 26 sites. There were 84 total patients enrolled and randomized 3:1 to be treated with 600 mg of ORKA-001 at the 0 and 4-week marks, or with a matching placebo. Baseline characteristics were noted by Strober and coauthors as broadly consistent with those seen in recent moderate-to-severe psoriasis research.

At Week 16, they found 63.5% of ORKA-001-treated individuals attained the study’s primary endpoint of 100% in their Psoriasis Area and Severity Index (PASI) score, representing complete skin clearance.

 Additionally, the team identified identical data for Investigator's Global Assessment (IGA) scores of 0 0. Among key secondary endpoints, the investigators noted attainment among 83% of participants of PASI 90 IGA 0/1 among 84% at Week 16.

Among those in the placebo arm, 1 of 21 subjects met those thresholds, in line with historical placebo response rates.

 All of the study’s figures were calculated using non-responder imputation. Oruka noted these clearance rates were numerically superior to those reported for other interleukin (IL)-23p19 inhibitors in cross-trial comparisons. They also described such findings as comparable to the highest rates on record across any mechanism of action in the plaque psoriasis space.

ORKA-001’s safety profile was also found to be favorable, with no serious treatment-emergent adverse events (TEAEs) observed by Strober et al.

 They also found the single severe TEAE recorded in the study was seen in the placebo arm. Overall TEAE rates were similar between cohorts, with 51% in the ORKA-001 cohort versus 57% on placebo. The investigators noted upper respiratory tract infection the only event seen in 5% or more of those assessed in either group. No injection site reactions were found.

The phase 1 trial’s updated pharmacokinetic and pharmacodynamic data continue to support the potential for an annual dosing regimen, with ORKA-001 concentrations remaining above effective trough levels for a full year following a single 600 mg dose and sustained IL-23 pathway inhibition identified by the investigative team throughout.

In the company’s release, they noted plans to present longer-term EVERLAST-A data, including 28-week efficacy results for the full cohort and 52-week follow-up for a patient subset, in the second half of 2026. The phase 2b EVERLAST-B findings are anticipated for release in 2027.

Oruka Therapeutics Announces Positive Week 16 Data for ORKA-001 from the Ongoing EVERLAST-A Phase 2a Trial in Moderate-to-Severe Plaque Psoriasis. Oruka Therapeutics, Inc. April 27, 2026. 

https://ir.orukatx.com/news-releases/news-release-details/oruka-therapeutics-announces-positive-week-16-data-orka-001

Kimmel GW, Lebwohl M. Psoriasis: Overview and Diagnosis. Evidence-Based Psoriasis. 2018 Jul 1:1–16. 

Interim Week 16 results from EVERLAST-A suggest ORKA-001, a half-life–extended IL-23p19 monoclonal antibody, delivers high levels of skin clearance in moderate-to-severe plaque psoriasis with a favorable tolerability profile. In 84 randomized patients, two 600 mg doses at Weeks 0 and 4 produced PASI 100 in 63.5% and strong PASI 90/IGA responses versus minimal placebo activity using non-responder imputation. Pharmacokinetic/pharmacodynamic readouts support potential once-annual dosing, with longer-term data expected in 2026–2027.

These Week 16, phase 2a findings from the EVERLAST-A study assessing ORKA-001 highlight the treatment's potential in those with plaque psoriasis.

Plaque Psoriasis

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

EVERLAST-A: Positive Phase 2a Data Observed for ORKA-001 in Psoriasis at Week 16

Diana Isaacs, PharmD, is an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic.

Podcasts

Viral Shah, MD, joins the show to break down his AACE 2026 presentation on the benefits of using GLP-1 RAs in patients with T1D.

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Diabetes Dialogue

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Strategic Alliance Partnership

Diabetes Dialogue: Expanding GLP-1 Usage Into Type 1 Diabetes With Viral Shah, MD

David Kass, MD, is the Abraham and Virginia Weiss Professor of Cardiology at the Johns Hopkins University School of Medicine.

Kass explains recent findings from a study that suggest myocardial dysfunction in HFpEF may be reversible with weight loss. 

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

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HFpEF Myocardial Dysfunction May Be Reversible With Weight Loss, With David Kass, MD

Funke Pickering, MD, senior medical director at Inovalon.

Pickering discusses data linking social risk factors to hospitalization and costs in MDD and implications for screening and care models.


Psychiatry

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Major Depressive Disorder

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Social Risk Factors Drive MDD Hospitalization, With Funke Pickering, MD

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.

FDA cleared Control-IQ+ for pregnancy in type 1 diabetes, expanding automated insulin delivery options during gestation.

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

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.

Phase 3 HAELO data show significant reductions in attack rates and treatment burden with a single-dose in vivo CRISPR therapy; BLA submission underway with FDA.

Single-Dose Lonvoguran Ziclumeran Cuts HAE Attacks by 87% in Phase 3 Trial

Michelle Bichchau Nguyen, MD, MBA, MPH, is an associate professor of dermatology at Tufts University School of Medicine and the director of Mohs Micrographic Surgery.


In this interview, Nguyen discusses improving patient experiences during surgical procedures in dermatology practices, such as Mohs surgery.

Q&A: Tips to Improve Dermatologic Surgery Experience, With Michelle Bichchau Nguyen, MD, MBA, MPH

This supplemental New Drug Application for roflumilast cream (Zoryve) to the FDA was supported by the INTEGUMENT-INFANT open-label study.

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.

Roflumilast Cream 0.05% sNDA Submitted to FDA for Infants Down to 3 Months with Atopic Dermatitis

The FDA approved anifrolumab via a once-weekly subcutaneous autoinjector for moderate to severe SLE based on phase 3 TULIP-SC trial results.

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

Patrick Campbell is the editorial director of HCPLive. Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter and/or multimedia specialist with the Pocono Record, Star News Group, and NJ Advance Media. He is the executive producer for multiple HCPLive podcasts, including Diabetes Dialogue, Don't Miss a Beat, Kidney Compass, Medical Ethics Unpacked, The Medical Sisterhood, and Skin of Color Savvy. 


Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

The FDA approved a lumateperone sNDA adding relapse prevention data in schizophrenia based on a 63% reduction in relapse risk versus placebo.

Schizophrenia

The HCPLive schizophrenia page is a resource for medical news and expert insights on the mental disorder. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for schizophrenia, and more.

Lumateperone sNDA Approved with Relapse Prevention Data in Schizophrenia

AbbVie submitted an FDA application for risankizumab subcutaneous induction in Crohn's disease based on phase 3 AFFIRM data.

Gastroenterology

Gastroenterology condition center page is a comprehensive resource for clinical news and insights on digestive and GI conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for 

, IBS and IBD, Crohn's disease, and more.

Inflammatory Bowel Disease

On the HCPLive inflammatory bowel disease page, resources on the topics of medical news and expert insight into IBD can be found. Content includes articles, interviews, videos, podcasts, and breaking news on IBD and more.

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