JNJ's Nipocalimab Meets Goal in Phase II Study for Systemic Lupus

Johnson & Johnson JNJ announced that the phase IIb JASMINE study, which evaluated its pipeline candidate, nipocalimab, for treating adult patients with systemic lupus erythematosus (SLE), has met the primary endpoint.

The JASMINE study met the primary endpoint, which is the percentage of patients achieving Systemic Lupus Erythematosus Responder Index composite response at week 24 with statistical significance.

The study also met the key secondary and exploratory endpoints, including those indicating the potential of nipocalimab for steroid sparing. In the study, nipocalimab showed a safety and tolerability profile similar to that seen in prior phase II studies, with no new safety concerns.

Based on the positive data from the phase IIb JASMINE study, the company plans to initiate a phase III program on nipocalimab for treating SLE,  a serious autoantibody disease in which the immune system attacks the body’s own tissues, potentially causing life-threatening systemic organ damage.

JNJ’s Price Performance

In the past six months, shares of J&J have rallied 31.4% compared with the industry’s increase of 18.1%.

Nipocalimab is already marketed by the name of Imaavy in the United States for treating generalized myasthenia gravis, a chronic, incurable autoimmune condition. While the FDA approved Imaavy in April 2025, it was approved in the EU in December 2025.

Besides SLE, nipocalimab, a fully human FcRn blocker, is also being evaluated in several mid-to-late-stage studies for various immune-mediated conditions like warm autoimmune hemolytic anemia, hemolytic disease of the fetus and newborn, Sjogren’s disease and idiopathic inflammatory myopathy. J&J believes that nipocalimab has a pipeline-in-a-product potential.

JNJ Seeks EU Nod for Tecvayli Expanded Use in Multiple Myeloma

In a separate press release, J&J announced that it has submitted a Type II variation application to the European Medicines Agency seeking approval for the expanded use of its new multiple myeloma drug, Tecvayli (teclistamab).

The company is now seeking approval of Tecvayli in combination with Darzalex subcutaneous (daratumumab SC) formulation for treating adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy. The application is supported by data from the phase III MajesTEC-3 study.

Tecvayli is currently approved in Europe as monotherapy for treating patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have shown disease progression on the last therapy.

J&J recently submitted a supplemental biologics license application to the FDA seeking approval for Tecvayli in combination with Darzalex Faspro as a treatment for RRMM.

JNJ's Zacks Rank & Stocks to Consider

J&J has a Zacks Rank #3 (Hold) currently.

Some better-ranked stocks in the biotech sector are CorMedix CRMD and Exact Sciences EXAS, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for CorMedix’s 2026 earnings per share (EPS) have moved up from $2.49 to $2.88. CRMD stock has decreased 0.2% in the past six months.

CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.

In the past 60 days, estimates for Exact Sciences’ 2026 EPS have moved up from $1.33 to $1.40. EXAS stock has surged 89.8% in the past six months.

Exact Sciences’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 352.28%.

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This article originally published on Zacks Investment Research (zacks.com).

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