Rozanolixizumab

Johnson & Johnson (J&J; NYSE: JNJ) announced receipt of Fast Track designation from the US FDA for nipocalimab, an investigational anti-neonatal Fc receptor (FcRn) monoclonal antibody, for the treatment of adults with systemic lupus erythematosus (SLE). This is the fifth FDA Fast Track designation for nipocalimab, which Johnson & Johnson acquired through its USD 6.5 billion purchase of Momenta Pharmaceuticals in October 2020. FDA Fast Track designation is available to therapies intended to treat serious conditions where evidence suggests the drug may address an unmet medical need. The procedural benefits include more frequent interactions with the agency during development, eligibility for rolling submission of a Biologics License Application (BLA), and potential qualification for Accelerated Approval or Priority Review at the time of filing. The designation rests on data from the Phase II JASMINE study (NCT04882878), a 52-week, randomized, double-blind, placebo-controlled, dose-ranging trial enrolling 228 adults with active SLE. According to Johnson & Johnson, the study met its primary endpoint and multiple secondary and exploratory endpoints, demonstrating reduction in lupus disease activity and steroid-sparing potential. Nipocalimab is the only FcRn blocker to have shown reduction in SLE disease activity in a controlled Phase II setting. Following these results, Johnson & Johnson initiated enrollment in the Phase III GARDENIA study (NCT07438496) of adults with active SLE. Nipocalimab functions by binding FcRn with high affinity, blocking IgG recycling and thereby reducing circulating pathogenic immunoglobulin G (IgG) autoantibodies while preserving other immune functions. J&J is developing the molecule across rheumatologic, rare autoantibody, and maternal-fetal indications. Active or completed trials include Phase III studies in generalized myasthenia gravis (gMG), where FDA granted Priority Review in Q4 2024, and in fetal and neonatal alloimmune thrombocytopenia (FNAIT). Nipocalimab also holds Breakthrough Therapy designations for hemolytic disease of the fetus and newborn (HDFN) and Sjögren’s disease. SLE is a chronic autoimmune disease affecting an estimated 3 to 5 million people worldwide, with disproportionate prevalence among women of reproductive age. The disease drives inflammation across multiple organ systems, including the kidneys, skin, joints, and central nervous system, and carries a risk of irreversible organ damage compounded by long-term glucocorticoid dependence. Only two biologic therapies have received FDA approval for SLE: belimumab (GSK, approved 2011), a B-lymphocyte stimulator inhibitor, and anifrolumab (AstraZeneca, branded Saphnelo, approved 2021), a type I interferon receptor antibody. No novel molecular entity for SLE has been approved since anifrolumab. The FcRn target class is crowded. Argenx markets efgartigimod (Vyvgart) for gMG and is studying it in lupus nephritis in the Phase II/III ALKIVIA trial (NCT05523570). UCB’s rozanolixizumab and Immunovant’s batoclimab are both in Phase III for gMG and other IgG-mediated conditions, though neither has disclosed an active SLE program. Nipocalimab differs from efgartigimod in modality: it is a full-length monoclonal antibody rather than an engineered Fc fragment, and J&J characterizes it as “immunoselective”, a term denoting its design to lower pathogenic IgG without broadly suppressing other immunoglobulin classes or complement-dependent functions. Whether this translates into a differentiated clinical profile in SLE remains to be established in Phase III data.

UCB raked in €7.39 billion ($8.72 billion) last year as Bimzelx further entrenched itself in the hidradenitis suppurativa market. After UCB’s Bimzelx scored five approvals in just two years, the Belgian drugmaker has quickly made a blockbuster out of its up-and-coming immunology powerhouse.As the first med to selectively inhibit IL-17F as well as IL-17A, Bimzelx entered the crowded plaque psoriasis arena in 2023 before tacking on indications the following year in active psoriatic arthritis, active non-radiographic axial spondyloarthritis, active ankylosing spondylitis and, most recently, hidradenitis suppurativa (HS). The regulatory and commercial momentum brought modest 2024 Bimzelx sales of €607 million ($716 million), skyrocketing to €2.22 billion ($2.6 billion) in 2025, according to UCB’s recent fourth-quarter and full-year earnings report. That’s already halfway to the company’s stated peak sales expectations of at least 4 billion euros ($4.4 billion) for the med. "In 2025, we demonstrated unwavering consistency in executing our long-term growth strategy, solidifying a decade of growth,” CEO Jean-Christophe Tellier said in a statement.As it stands, 53% of Bimzelx’s sales come from its psoriasis indication, as UCB laid out in an investor presentation (PDF). However, the drug holds its largest patient share in HS, where it captures a “global dynamic patient share” of around 45%. In HS, Bimzelx and UCB have an opportunity to make a real commercial mark. Before Novartis’ Cosentyx broke into the HS space in 2023, AbbVie’s now-off-patent Humira was the only biologic cleared for use in the disease. Bimzelx picked up its HS nod in November of 2024 after a phase 3 data drop that SVB analysts described as “incrementally better than” trial results for Cosentyx. Since then, the HS market for biologics has grown 24% between October 2024 and October 2025, UCB said. The company expects the disease space to become a $5 billion market between 2025 and 2030.  Other than presenting big competition for Novartis, Bimzelx may be giving AbbVie and other top competitors in the immunology space a reason to sweat as well. Last February, a Spherix Global Insights survey found that awareness of UCB’s drug was tracking ahead of AbbVie’s Rinvoq and Skyrizi in psoriatic arthritis.To confirm its drug’s clinical positioning against Skyrizi, UCB is putting Bimzelx’s prowess to the test with a head-to-head study versus the AbbVie drug in psoriatic arthritis. The trial is expected to read out in the first half of this year.  While Bimzelx is firmly UCB’s top growth driver, several other meds played into the company's €7.39 billion ($8.72 billion) in 2025 revenues. Other key contributors include 2023-approved myasthenia gravis drugs Rystiggo and Zilbrysq, plus Evenity, which treats osteoporosis in certain postmenopausal women, and Fintepla, a treatment for seizures associated with Dravet syndrome and Lennox-Gastaut syndrome. Together, the collection of five growth drivers more than doubled their combined net sales to exceed €3.3 billion ($3.9 billion) in 2025, Tellier pointed out.  Now, the pressure is on to continue the growth into 2026 and beyond. To do so, the company is pouring $5 billion into a manufacturing expansion as it simultaneously scales up partnerships with U.S.-based contract manufacturers to ensure the continued supply of its growth drivers.Meanwhile, UCB will soon launch its first ultra-rare disease drug in the U.S. in Kygevvi, a treatment for genetic mitochondrial disease thymidine kinase 2 deficiency (TK2d) that was approved last November. The company is targeting around 1,500 patients globally and is planning on initiating an “agile” rollout early this year, according to the presentation.