argenx’s ALKIVIA Phase 3 Study Demonstrates Rapid and Durable Clinical Improvement with Efgartigimod in Autoimmune Myositis; Johnson & Johnson Reports Phase 2 Nipocalimab Data in Sjögren’s Disease Highlighting Patient-Prioritized Symptom Improvements; Immunocore Unveils Promising Brenetafusp–KIMMTRAK Data in Metastatic Uveal Melanoma; Real-World Study Shows REPATHA Cuts Heart Attack Risk by 20% Compared with Ezetimibe; Health Canada Approves Moderna’s mRNA Flu Vaccine and Combined Influenza-COVID-19 Vaccine

argenx Shares Phase 3 ALKIVIA Evidence of Rapid and Sustained Efgartigimod Response in Autoimmune Myositis

argenx SE announced that findings from the Phase 3 ALKIVIA study, highlighting the rapid and sustained clinical improvement achieved with VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in patients with autoimmune myositis, will be presented as a late-breaking oral presentation (#LB24) at the American College of Rheumatology (ACR) Convergence 2026 on November 11, 2026, from 9:15 to 9:30 a.m. ET.

In the combined immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM) population, the study successfully achieved its primary endpoint, with efgartigimod-treated patients demonstrating a statistically significant and clinically meaningful 15.4-point greater improvement in mean Total Improvement Score (TIS) at Week 52 compared with placebo (48.0 vs. 32.6; p=0.0011). Key secondary endpoints were also met in the combined population, encompassing response rate, time to response, muscle strength, and disease activity. Efgartigimod was generally well tolerated, with its observed safety profile aligning with findings from previous studies and its established safety characteristics.

“Results from this Phase 3 study further reinforce the growing evidence that FcRn inhibition can provide meaningful and sustained clinical benefits to patients with autoimmune myositis,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx. “ALKIVIA highlights the clinical importance of reducing pathogenic autoantibodies and further supports the potential of efgartigimod as the first targeted treatment for IMNM. We are advancing with urgency to make efgartigimod available to individuals living with IMNM, who currently have no approved treatment options, while remaining dedicated to its continued development for patients with DM.”

Johnson & Johnson Unveils Phase 2 Nipocalimab Study Insights in Sjögren’s Disease, Focusing on Symptoms Most Valued by Patients

Johnson & Johnson announced new patient experience findings from the Phase 2 DAHLIAS study evaluating nipocalimab in Sjögren’s disease (SjD), a chronic, systemic, autoantibody-driven condition affecting approximately four million people worldwide. The findings indicate that relief from mouth dryness is the symptom improvement patients value most, complementing previously reported Phase 2 results demonstrating increased saliva production among patients treated with nipocalimab. Mouth dryness was also the most commonly reported symptom, cited by 96% of surveyed patients. These patient insights contributed to the development of the ongoing Phase 3 nipocalimab study in SjD and are included among 23 abstracts on nipocalimab scheduled for presentation at the American College of Rheumatology (ACR) Convergence 2026.

“These patient insights reinforce the broad, systemic nature of Sjögren’s disease and the importance of recognizing and addressing the symptoms and outcomes that matter most to patients,” said Leonard L. Dragone, M.D., Ph.D., Disease Area Leader, Autoantibody and Rheumatology, Johnson & Johnson. “Together, these findings alongside the positive Phase 2 clinical results provide important context as we advance nipocalimab as a potential targeted approach designed to address the underlying biology of this serious autoantibody-driven disease.”

Building on the positive Phase 2 DAHLIAS results, which demonstrated that nipocalimab significantly reduced disease activity and severity in patients with moderate-to-severe SjD, Johnson & Johnson initiated the Phase 3 DAFFODIL study in adults with moderate-to-severe disease. The DAFFODIL study design incorporates the systemic nature of SjD and prioritizes outcomes meaningful to patients, evaluating disease activity alongside dryness, pain, fatigue, quality of life, and patient-reported improvement.

Nipocalimab is the only neonatal Fc receptor (FcRn) blocker to have received both Breakthrough Therapy Designation and Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of adults with moderate-to-severe SjD.

Immunocore Presents Encouraging Phase 1/2 Data for Brenetafusp–KIMMTRAK in Metastatic Uveal Melanoma

Immunocore announced data from its Phase 1/2 study investigating brenetafusp as monotherapy and in combination with KIMMTRAK in HLA-A*02:01-positive patients with metastatic uveal melanoma (mUM). The findings were presented during a poster session at the 2026 Society for Immunotherapy of Cancer (SITC) Annual Meeting.

KIMMTRAK and brenetafusp are ImmTAC therapies directed against gp100 and PRAME, respectively, with PRAME recognized as an established negative prognostic biomarker in mUM. KIMMTRAK is the first bispecific T-cell receptor therapy to demonstrate an overall survival benefit in a solid tumor and represents the standard of care for HLA-A02:01-positive adults with unresectable or metastatic uveal melanoma. Brenetafusp, an investigational therapy, is being studied across multiple tumor types, including in first-line cutaneous melanoma through the Phase 3 PRISM-MEL-301 trial. The combination of brenetafusp and KIMMTRAK is intended to assess whether simultaneous targeting of both antigens can enhance target engagement and T-cell-mediated tumor killing, potentially improving clinical outcomes in HLA-A02:01-positive patients with mUM.

Dr. Mohammed Dar, Executive Vice President of Clinical Development and Chief Medical Officer of Immunocore, stated that the encouraging Phase 1 findings indicate that combining brenetafusp with tebentafusp may provide a meaningful new treatment option for HLA-A*02:01-positive patients with mUM. He further emphasized that the company’s experience with KIMMTRAK supports the potential of a dual-targeting ImmTAC strategy against gp100 and PRAME to deliver greater clinical benefits.

As of the June 2026 data cut-off, 22 patients with mUM had received clinically active doses of brenetafusp monotherapy, while 26 patients had been treated with brenetafusp in combination with tebentafusp. Immunocore considers these findings the first evidence demonstrating clinical activity alongside a manageable safety profile for a combination of two T-cell engagers in a solid tumor.

Among the 17 evaluable first-line patients treated with the combination, the overall response rate (ORR) was 29%, with a median duration of response (mDoR) of 24.1 months. The disease control rate (DCR) reached 71%, while median progression-free survival (mPFS) was 8.1 months. Median overall survival (mOS) had not been reached at the data cut-off, following a median follow-up of 29 months. Overall survival rates were 88% at 1 year and 70% at 2 years, with 10 of the 17 patients continuing treatment in the study. Among patients achieving overall survival beyond 2 years, 64% (7 of 11) had received only the brenetafusp-tebentafusp combination.

In the 16 evaluable patients receiving brenetafusp monotherapy in the second-line or later treatment setting, ORR was 19%, mDoR was 14.5 months, DCR was 63%, and mPFS was 4.2 months. Median overall survival was 20.3 months, with 1-year and 2-year OS rates of 63% and 31%, respectively.

Brenetafusp monotherapy and its combination with tebentafusp demonstrated generally favorable tolerability, with safety findings consistent with the known profiles of the individual agents and no new safety signals identified. Cytokine release syndrome (CRS), which was reversible and manageable, was the most common treatment-related adverse event (TRAE), occurring in 77% of combination-treated patients and 73% of monotherapy-treated patients. Most CRS events were Grade 1 or 2, with no Grade 3 or 4 CRS reported in the combination group and Grade 3 CRS observed in 5% of patients receiving brenetafusp monotherapy.

Grade 3 or 4 TRAEs occurred in 38% of combination-treated patients and 41% of monotherapy-treated patients. The most frequently reported event was a transient reduction in lymphocyte counts, which resolved without intervention. No treatment-related adverse events resulted in treatment discontinuation or death in either cohort.

Molecular response data further supported the activity of the combination. Of the nine patients evaluable for circulating tumor DNA (ctDNA) response, eight (89%) demonstrated a molecular response, while four (44%) achieved ctDNA clearance.

Immunocore plans to initiate DUET-UVEAL, a randomized Phase 2/3 clinical trial, to further investigate the brenetafusp-tebentafusp combination in HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma.

The SITC findings were derived from an ongoing Phase 1/2 study (NCT04262466; EudraCT 2019-004046-16) evaluating brenetafusp as monotherapy and in combination across multiple solid tumors, including HLA-A*02:01-positive patients with unresectable or metastatic uveal melanoma. Brenetafusp and tebentafusp were administered through weekly intravenous infusions using a step-up dosing regimen.

REPATHA Outperforms Ezetimibe in Reducing Heart Attack Risk by 20% in Real-World Study

Amgen announced findings from a large-scale real-world study demonstrating that Repatha (evolocumab) was associated with a 20% reduction in the risk of fatal or nonfatal myocardial infarction (MI) compared with ezetimibe among patients with atherosclerotic cardiovascular disease (ASCVD) and a history of statin use. The study included more than 544,000 adults followed for up to four years. The results were published in The American Journal of Preventive Cardiology.

“Although decades of evidence have established that lowering LDL cholesterol reduces cardiovascular risk, many patients with ASCVD remain unable to achieve recommended LDL-C levels with statin therapy alone,” said Paul Burton, M.D., Ph.D., chief medical officer at Amgen. He noted that the findings offer physicians meaningful comparative evidence when selecting an additional lipid-lowering therapy, demonstrating that patients treated with Repatha experienced a 20% lower risk of heart attack or heart attack-related death than those receiving ezetimibe.

In the subgroup of patients with baseline low-density lipoprotein cholesterol (LDL-C) measurements (N = 225,048), the four-year cumulative incidence of heart attack was lower among Repatha-treated patients than among those receiving ezetimibe, an oral LDL-C-lowering therapy that inhibits cholesterol absorption, at 5.88% versus 7.76%, respectively. The analysis evaluated cardiovascular outcomes across a substantial patient population using rigorous analytical methods. Its large scale and carefully designed real-world methodology provide a comprehensive comparative assessment of cardiovascular outcomes associated with the two therapies. The findings complement existing clinical trial evidence with practical real-world data and may support more informed treatment decisions.

According to Nihar Desai, M.D., M.P.H., associate professor of medicine and vice chief of the Section of Cardiovascular Medicine at Yale University School of Medicine, the updated ACC/AHA Multisociety Guidelines recognize ezetimibe and PCSK9 inhibitors, including evolocumab, as non-statin treatment options for patients with ASCVD. However, clinicians have historically lacked direct comparative cardiovascular outcomes evidence to guide the selection between these therapies, particularly when pursuing recommended LDL-C targets of less than 70 mg/dL and less than 55 mg/dL. Desai emphasized that the study provides important comparative evidence to help healthcare professionals differentiate between treatment options and make more informed decisions aimed at lowering cardiovascular risk.

The study employed a rigorous design intended to emulate a randomized clinical trial, comparing cardiovascular outcomes among adults with ASCVD who initiated Repatha or ezetimibe in routine U.S. clinical practice. The analysis utilized de-identified patient information from Komodo Healthcare Map® and implemented robust analytical techniques to achieve comparable baseline characteristics between the two treatment groups.

Moderna Receives Health Canada Authorization for mRNA Flu and Flu-COVID-19 Combination Vaccines

Moderna, Inc. announced that Health Canada has granted authorization to mFLUSIVA® (Influenza mRNA vaccine; mRNA-1010) and mCOFLU® (Combined Influenza and COVID-19 mRNA vaccine; mRNA-1083) for use in adults aged 50 years and older. With these decisions, Canada becomes the first country globally to authorize both Moderna’s seasonal mRNA influenza vaccine and its combination influenza and COVID-19 vaccine.

“Health Canada’s authorizations of mFLUSIVA and mCOFLU today mark another important step in bringing the benefits of mRNA technology to seasonal respiratory vaccination. It’s not every day that a company gets two product approvals on the same day,” said Stéphane Bancel, Chief Executive Officer of Moderna. “Influenza and COVID-19 continue to place a significant burden on public health, particularly among older adults. These milestones reflect our commitment to advancing innovative vaccine options that help protect Canadians and support more resilient health systems.”

mFLUSIVA represents Canada’s first mRNA-based seasonal influenza vaccine, while mCOFLU is the country’s first combined influenza and COVID-19 vaccine. These authorizations follow the U.S. Food and Drug Administration’s approval of mFLUSIVA in August 2026 and the European Commission’s authorization of Moderna’s combination influenza and COVID-19 mRNA vaccine, marketed as mCOMBRIAX®, in April 2026. Both vaccines are currently undergoing regulatory evaluation in additional markets.

mFLUSIVA has been authorized for active immunization in adults aged 50 years and older to prevent influenza disease caused by influenza A and B virus subtypes included in the vaccine. Similarly, mCOFLU is authorized for active immunization in adults aged 50 years and older for the prevention of influenza disease caused by influenza A and B virus types represented in the vaccine, as well as SARS-CoV-2 infection.

Health Canada’s authorization of mFLUSIVA is based on findings from the pivotal Phase 3 mRNA-1010-P304 study (NCT06602024), a randomized, active-controlled trial conducted across 11 countries involving approximately 40,800 adults aged 50 years and older. The vaccine achieved all predefined statistical success criteria, including the highest prespecified superiority threshold. It demonstrated relative vaccine efficacy of 26.6% (95% CI: 16.7–35.4) among adults aged 50 years and older and 27.4% (95% CI: 12.1–40.0) among those aged 65 years and older compared with a standard-dose inactivated influenza vaccine against RT-PCR-confirmed, protocol-defined influenza-like illness caused by influenza A or B.

Additional evidence supporting the authorization was obtained from the Phase 3 mRNA-1010-P303 Part C study (NCT05827978), which demonstrated superior antibody responses with mFLUSIVA compared with a high-dose inactivated influenza vaccine in adults aged 65 years and older.