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June 11, 2026

IMAAVY® (nipocalimab-aahu) demonstrates durable hemoglobin response and rapid onset of effect in pivotal Phase 2/3 study in warm autoimmune hemolytic anemia (wAIHA), an autoantibody-driven disease with no FDA-approved therapies

· Patients in the IMAAVY 30 mg/kg treatment groupa achieved statistically significant durable hemoglobin responseb, with mean hemoglobin improvement of at least 1 g/dL as early as Week 1c · More patients treated with IMAAVY experienced improvement in fatigued and corticosteroid dose reductionse · IMAAVY is designed to target pathogenic immunoglobulin G (IgG) autoantibodies in warm autoimmune hemolytic anemia while preserving immune function · Pivotal results will be presented at EHA 2026

Innovative Medicine

May 12, 2026

Johnson & Johnson showcases hematology leadership with 30+ presentations at the 2026 European Hematology Association (EHA) Congress

· Johnson & Johnson will present 30+ abstracts at European Hematology Association 2026, highlighting leadership in hematology with data across multiple myeloma and leukemia, and first pivotal data in warm autoimmune hemolytic anemia · Phase 3 results evaluate the potentially transformative investigational combination of TALVEY®, the first GPRC5D‑targeted bispecific antibody, in combination with DARZALEX FASPRO® with or without pomalidomide for patients with relapsed or refractory multiple myeloma in earlier lines of therapy · Pivotal Phase 2/3 results potentially position IMAAVY® as the first FDA-approved treatment for warm autoimmune hemolytic anemiaa designed to target the IgG autoantibodies responsible for red blood cell destruction

Innovative Medicine

April 27, 2026

FDA grants Priority Review for IMAAVY® (nipocalimab-aahu) as the potential first approved treatment for people living with warm autoimmune hemolytic anemia (wAIHA)

Priority Review is granted to medicines that may offer significant improvements in safety or effectiveness for serious conditions like warm autoimmune hemolytic anemia, a life-threatening disease in which pathogenic immunoglobulin G autoantibodies attach to and destroy red blood cells, leading to debilitating anemia IMAAVY is designed to target the underlying cause of warm autoimmune hemolytic anemia by reducing circulating immunoglobulin G, including autoantibodies, while preserving critical immune functions Pivotal study showed rapid and durable hemoglobin responsea and fatigue improvementb compared to placebo in patients with warm autoimmune hemolytic anemia

Innovative Medicine

February 24, 2026

Johnson & Johnson seeks FDA approval of IMAAVY® (nipocalimab-aahu) as the first-ever FDA-approved treatment for warm autoimmune hemolytic anemia (wAIHA)

Data from the pivotal ENERGY trial showed IMAAVY® produced a rapid and durable hemoglobin responsea in wAIHA Currently no FDA-approved therapies are available for wAIHA, a rare, heterogeneous, life-threatening disease in which pathogenic immunoglobulin (IgG) autoantibodies attach to and destroy red blood cells, leading to debilitating anemia

Innovative Medicine

June 23, 2025

IMAAVY™ (nipocalimab-aahu) showed greater sustained disease control versus approved FcRn blockers for generalized myasthenia gravis (gMG) at multiple timepoints over 24 weeks in newly published indirect treatment comparison (ITC)

The ITC compared all published Phase 3 data of these treatments, leveraging longitudinal results, and findings reinforce the importance of consistent, sustained disease control in managing a chronic autoantibody disease like gMG IMAAVY, an FcRn blocker, received U.S. FDA approval earlier this year for the broadest population of individuals living with gMG, including anti-AChR and anti-MuSK antibody positive adults and pediatric gMG patients aged 12 and older

Innovative Medicine

April 30, 2025

Johnson & Johnson receives FDA approval for IMAAVYTM (nipocalimab-aahu), a new FcRn blocker offering long-lasting disease control in the broadest population of people living with generalized myasthenia gravis (gMG)

First and only FcRn blocker approved in anti-AChR and anti-MuSK antibody positive adults and pediatric gMG patients aged 12 and older IMAAVY delivered rapid and substantial reduction in immunoglobulin G (IgG) levels, one of the root causes of gMG, in both the adult and pediatric pivotal studies gMG patients taking IMAAVY demonstrated 20 months of lasting disease control and symptom relief in the pivotal Vivacity-MG3 study and ongoing open-label extension (OLE)

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Press releases

IMAAVY® (nipocalimab-aahu) demonstrates durable hemoglobin response and rapid onset of effect in pivotal Phase 2/3 study in warm autoimmune hemolytic anemia (wAIHA), an autoantibody-driven disease with no FDA-approved therapies

Johnson & Johnson showcases hematology leadership with 30+ presentations at the 2026 European Hematology Association (EHA) Congress

FDA grants Priority Review for IMAAVY® (nipocalimab-aahu) as the potential first approved treatment for people living with warm autoimmune hemolytic anemia (wAIHA)

Johnson & Johnson seeks FDA approval of IMAAVY® (nipocalimab-aahu) as the first-ever FDA-approved treatment for warm autoimmune hemolytic anemia (wAIHA)

IMAAVY™ (nipocalimab-aahu) showed greater sustained disease control versus approved FcRn blockers for generalized myasthenia gravis (gMG) at multiple timepoints over 24 weeks in newly published indirect treatment comparison (ITC)

Johnson & Johnson receives FDA approval for IMAAVYTM (nipocalimab-aahu), a new FcRn blocker offering long-lasting disease control in the broadest population of people living with generalized myasthenia gravis (gMG)

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Newsroom

Press releases

IMAAVY® (nipocalimab-aahu) demonstrates durable hemoglobin response and rapid onset of effect in pivotal Phase 2/3 study in warm autoimmune hemolytic anemia (wAIHA), an autoantibody-driven disease with no FDA-approved therapies

Johnson & Johnson showcases hematology leadership with 30+ presentations at the 2026 European Hematology Association (EHA) Congress

FDA grants Priority Review for IMAAVY® (nipocalimab-aahu) as the potential first approved treatment for people living with warm autoimmune hemolytic anemia (wAIHA)

Johnson & Johnson seeks FDA approval of IMAAVY® (nipocalimab-aahu) as the first-ever FDA-approved treatment for warm autoimmune hemolytic anemia (wAIHA)

IMAAVY™ (nipocalimab-aahu) showed greater sustained disease control versus approved FcRn blockers for generalized myasthenia gravis (gMG) at multiple timepoints over 24 weeks in newly published indirect treatment comparison (ITC)

Johnson & Johnson receives FDA approval for IMAAVYTM (nipocalimab-aahu), a new FcRn blocker offering long-lasting disease control in the broadest population of people living with generalized myasthenia gravis (gMG)

You are now leaving jnj.com/innovativemedicine