Johnson & Johnson JNJ announced that the European Commission has approved Imaavy (nipocalimab) as an add-on therapy for the treatment of generalized myasthenia gravis (gMG) in adults and adolescents.
The targeted population for this approval includes patients aged 12 years and above who are anti-acetylcholine receptor or anti-muscle-specific kinase antibody-positive.
Following the latest nod, Imaavy became the first FcRn blocker available for both adult and adolescent patients with gMG in the EU.
Imaavy, a fully human FcRn blocker, was approved in the United States in April for treating gMG, a chronic, incurable autoimmune condition marked by debilitating symptoms such as muscle weakness and difficulty with chewing, swallowing and speaking.
JNJ's Price Performance
Year to date, shares of J&J have rallied 42.2% compared with the industry’s rise of 17.8%.
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More on the EU Nod for JNJ's Imaavy
The latest EU nod for Imaavy was based on data from the pivotal phase III Vivacity-MG3 study as well as data from the phase II/III Vibrance-MG study.
Data from the Vivacity-MG3 study showed that treatment with Imaavy plus standard of care (SOC) led to superior disease control versus those who received placebo plus SOC throughout 24 weeks. Also, patients treated with Imaavy experienced sustained disease control and symptom relief for up to 20 months in Vivacity-MG3 and its open-label extension.
The safety and tolerability profile was consistent with that observed in other studies on Imaavy.
Meanwhile, data from the phase II/III Vibrance-MG study showed that treatment with Imaavy plus SOC led to sustained disease control as measured by the primary endpoint of IgG reduction from baseline over 24 weeks versus placebo plus SOC.
The EU approval for Imaavy is likely to serve an area of high unmet medical need and offer long-term disease management for the estimated 56,000 to 123,000 people who live with gMG across Europe.
The approval in the EU was expected, as in September, the European Medicines Agency’s Committee for Medicinal Products for Human Use had recommended the approval of Imaavy for gMG.
J&J is also evaluating nipocalimab in late-stage studies for various immune-mediated conditions like warm autoimmune hemolytic anemia, hemolytic disease of the fetus and newborn, and Sjogren’s disease. It is also in mid-stage studies for idiopathic inflammatory myopathy and systemic lupus erythematosus. In fact, the company believes that nipocalimab has a pipeline-in-a-product potential.
JNJ's Zacks Rank & Stocks to Consider
J&J currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are CorMedix CRMD, Arcutis Biotherapeutics ARQT and ADMA Biologics ADMA. While CRMD currently sports a Zacks Rank #1 (Strong Buy), ARQT and ADMA carry a Zacks Rank #2 (Buy) each, at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CorMedix’s 2025 earnings per share (EPS) have increased from $1.83 to $2.87. EPS estimates for 2026 have moved up from $2.48 to $2.88 during the same period. CRMD stock has surged 20.8% year to date.
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 Arcutis Biotherapeutics’ loss per share have narrowed from 44 cents to 24 cents for 2025. During the same time, EPS estimates for 2026 have increased from 9 cents to 41 cents. Year to date, shares of ARQT have rallied 118%.
Arcutis Biotherapeutics’ earnings beat estimates in each of the trailing four quarters, the average surprise being 64.80%.
In the past 60 days, estimates for ADMA Biologics’ EPS have increased from 57 cents to 58 cents for 2025. During the same time, EPS estimates for 2026 have improved from 88 cents to 90 cents. Year to date, shares of ADMA have gained 13%.
ADMA Biologics’ earnings beat estimates in one of the trailing four quarters, matched once and missed the same on the remaining two occasions, with the average negative surprise being 3.01%.
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