Press Release

New Phase 3 Study Shows that Gazyva® (obinutuzumab) Significantly Reduces Lupus Disease Activity in SLE

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A new Phase 3 study published in the New England Journal of Medicine found that Gazyva® (obinutuzumab) significantly reduced disease activity and lowered steroid use in people with systemic lupus erythematosus (SLE), the most common form of lupus. The results were also presented today at the 15th European Lupus Society meeting, SLEuro 2026.  More than 75% of people treated with Gazyva plus standard therapy achieved at least … New Phase 3 Study Shows that Gazyva® (obinutuzumab) Significantly Reduces Lupus Disease Activity in SLE

Lupus Research Alliance Applauds U.S. FDA Fast Track Designation for Nipocalimab for Systemic Lupus Erythematosus 

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Decision Could Help Potential SLE Treatment Reach People Living With Lupus Sooner The Lupus Research Alliance applauds the decision by the U.S. Food and Drug Administration (FDA) to grant Fast Track designation for nipocalimab in development by Johnson & Johnson for the treatment of adults with systemic lupus erythematosus (SLE) – a chronic autoimmune disease for which there are few treatment options. The FDA grants this designation “to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need” – with the goal of … Lupus Research Alliance Applauds U.S. FDA Fast Track Designation for Nipocalimab for Systemic Lupus Erythematosus 

Lupus Therapeutics, the Clinical Affiliate of the Lupus Research Alliance, Broadens Proven Peer-to-Peer Program in Clinical Trials

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Today, Lupus Therapeutics, the clinical affiliate of the Lupus Research Alliance, announced the expansion of its proven peer-to-peer clinical research education program – Patient Advocates for Lupus Studies (PALS) – making it available to hundreds of individuals living with lupus across North America. The expansion builds on the program’s success to date and aims to … Lupus Therapeutics, the Clinical Affiliate of the Lupus Research Alliance, Broadens Proven Peer-to-Peer Program in Clinical Trials

Lupus Research Alliance Applauds U.S. FDA Breakthrough Therapy Designation for Litifilimab in Cutaneous Lupus Erythematosus

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The Lupus Research Alliance applauds the decision by the U.S. Food and Drug Administration (FDA) to grant Breakthrough Therapy designation for litifilimab (BIIB059) in clinical development by Biogen Inc. for the treatment of cutaneous lupus erythematosus (CLE) – a chronic skin disease for which there are no specifically approved treatments. The FDA grants this designation to expedite the review of drugs that may demonstrate substantial improvement over available therapies.   A common manifestation of lupus – a chronic and complex autoimmune disease – CLE primarily causes inflammation of the skin. Symptoms vary, but can include butterfly rashes, ring-shaped sores, or red, … Lupus Research Alliance Applauds U.S. FDA Breakthrough Therapy Designation for Litifilimab in Cutaneous Lupus Erythematosus

Lupus Research Alliance Showcases Research that will Shape Next Generation Treatments at ACR Convergence 2025 

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New York, N.Y., October 21, 2025 —  With lupus research accelerating at an unprecedented pace, the Lupus Research Alliance heads to ACR Convergence 2025 (October 24-29, Chicago), the annual meeting of the American College of Rheumatology, to demonstrate how its unique impact across the full research continuum is shaping the next generation of treatments and research.  As the … Lupus Research Alliance Showcases Research that will Shape Next Generation Treatments at ACR Convergence 2025 

Lupus Research Alliance Applauds U.S. FDA Approval of Gazyva® (Obinutuzumab) for Lupus Nephritis

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The Lupus Research Alliance applauds the approval by the U.S. Food and Drug Administration of Gazyva® (obinutuzumab) from Genentech for the treatment of adults with active lupus nephritis in combination with standard of care. This is a major step forward for the entire lupus community, as it is the only anti-CD20 monoclonal antibody targeting an … Lupus Research Alliance Applauds U.S. FDA Approval of Gazyva® (Obinutuzumab) for Lupus Nephritis

Lupus Therapeutics Announces a New, Groundbreaking Mechanism to Fund Clinical Studies Addressing the Impact of Diet, Nutrition, and Microbiome on Lupus

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Request for Applications: see article for details

Lupus Therapeutics, the clinical affiliate of the Lupus Research Alliance (LRA), today announced a pioneering funding mechanism to address one of the most common questions about lupus clinical care and management. The IDEAL (Investigate Dietary Approaches for Lupus) Initiative was established to fund pilot clinical studies assessing the impact of diet intervention on the lived experience … Lupus Therapeutics Announces a New, Groundbreaking Mechanism to Fund Clinical Studies Addressing the Impact of Diet, Nutrition, and Microbiome on Lupus

Lupus Therapeutics Statement on Phase 3 PHOENYCS GO Positive Data In Moderate-To-Severe Systemic Lupus

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News from ACR Convergence 2024

Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance (LRA), is encouraged by the positive Phase 3 PHOENYCS GO data reported by UCB and Biogen during ACR Convergence 2024. Study sponsors provided a detailed analysis of the pivotal trial to evaluate the efficacy and safety of dapirolizumab pegol (DZP) in patients with moderate-to-severe … Lupus Therapeutics Statement on Phase 3 PHOENYCS GO Positive Data In Moderate-To-Severe Systemic Lupus

Lupus Research Alliance Announces Lupus Research Highlights at ACR Convergence 2024

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Announcing LRA-supported research studies at ACR

Two reports by Lupus Therapeutics, the clinical affiliate of the LRA, and the Lupus Clinical Investigators Network (LuCIN), on promoting equity in lupus clinical trials, and identifying trial barriers and solutions The Lupus Research Alliance (LRA), the largest private funder of lupus research worldwide, today announced that 34 presentations, including research funded by the organization … Lupus Research Alliance Announces Lupus Research Highlights at ACR Convergence 2024

Lupus Therapeutics Announces Collaboration to Support the Evaluation of Non-Genetically Modified Cell-Based Therapy for Lupus Nephritis with Artiva Biotherapeutics

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Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance, announced a collaboration with Artiva Biotherapeutics, Inc. on a Phase 1 trial of the company novel NK cell-based therapy AlloNK® (also known as AB-101), in combination with anti-CD20 antibodies, for patients with active lupus nephritis – inflammation of the kidneys caused by lupus. AlloNK … Lupus Therapeutics Announces Collaboration to Support the Evaluation of Non-Genetically Modified Cell-Based Therapy for Lupus Nephritis with Artiva Biotherapeutics

Lupus Therapeutics Announces Partnership to Support the Evaluation of Natural Killer (NK) Cell Therapy in Lupus Nephritis

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Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance, today announced a partnership with Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing the engineered natural killer (NK) cell therapy NKX019 for refractory lupus nephritis that has not responded to standard treatment. Lupus Therapeutics has provided advisory services and will support Nkarta in early … Lupus Therapeutics Announces Partnership to Support the Evaluation of Natural Killer (NK) Cell Therapy in Lupus Nephritis

Lupus Therapeutics Partners with AbbVie on Clinical Trial Recruitment Efforts in SLE Through LuCIN Lupus Clinical Trial Network 

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Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance, announces a partnership with AbbVie Inc. for the Phase 3 clinical program of upadacitinib (RINVOQ®) in individuals living with systemic lupus erythematosus (SLE). In this partnership, Lupus Therapeutics will assist with study participant recruitment, site activation and engagement efforts through the Lupus Clinical Investigators … Lupus Therapeutics Partners with AbbVie on Clinical Trial Recruitment Efforts in SLE Through LuCIN Lupus Clinical Trial Network