STOCKHOLM - Johnson & Johnson (NYSE:JNJ) presented results from its Phase 2/3 ENERGY study showing that Imaavy (nipocalimab-aahu) achieved a statistically significant durable hemoglobin response in patients with warm autoimmune hemolytic anemia, according to a press release statement issued today.
The randomized, placebo-controlled trial enrolled 115 adults with wAIHA, a rare condition with no FDA-approved treatments. Patients receiving the 30 mg/kg dose of Imaavy showed approximately three times as many achieving durable hemoglobin levels versus placebo by 24 weeks. The primary endpoint required hemoglobin concentration of at least 10 g/dL and an increase from baseline of at least 2 g/dL for at least 28 days starting by Week 16, without rescue therapy.
Patients in the 30 mg/kg treatment group showed a mean hemoglobin increase of 1 g/dL at Week 1, compared to no change in the placebo group. Nearly two-thirds of patients achieved both a hemoglobin level of at least 10 g/dL and an increase of at least 2 g/dL from baseline by Week 24.
The study also measured improvements in fatigue and corticosteroid dose reductions. Changes in patient-reported fatigue were observed as early as Week 2. At Week 24, the mean percent reduction in corticosteroid dose was 15% in the Imaavy group compared with 4% in the placebo group.
The most common adverse reactions in patients treated with Imaavy were peripheral edema, diarrhea and fever. The safety profile was consistent with the established profile for Imaavy in generalized myasthenia gravis, its currently approved indication.
The results were presented at the European Hematology Association 2026 Congress. The data support a supplemental Biologics License Application for Imaavy, which has been granted FDA Priority Review.For deeper insights into JNJ’s pipeline and financial health, investors can access the comprehensive Pro Research Report, available for this and 1,400+ other US equities on InvestingPro.
Warm autoimmune hemolytic anemia affects approximately 1-3 new people per 100,000 per year. The condition involves autoantibodies that destroy red blood cells, resulting in anemia.
In other recent news, Johnson & Johnson announced a significant development as it entered into a definitive agreement to acquire Firefly Bio, Inc. for $1 billion in cash. This acquisition is aimed at enhancing Johnson & Johnson’s capabilities in targeting KRAS-driven tumors through Firefly Bio’s degrader antibody conjugate platform, Firelink. Additionally, Johnson & Johnson reported that its drug nipocalimab met the primary endpoint in a Phase 2 study for systemic lupus erythematosus, showing a notable decrease in disease activity at 24 weeks.
In another clinical trial, the company’s drug apalutamide demonstrated a 20% reduction in the risk of metastasis or death in patients with high-risk localized or locally advanced prostate cancer, according to results from the Phase 3 PROTEUS study. Moreover, Johnson & Johnson’s medical device unit, Abiomed, successfully defended against patent infringement allegations in a Massachusetts jury trial, with the jury ruling that Abiomed’s heart pumps did not violate Maquet Cardiovascular’s patent rights.
In legal matters, a Los Angeles jury awarded $32 million to the family of Maria Lozano, holding Johnson & Johnson liable for her mesothelioma, which was linked to asbestos-contaminated talc in the company’s baby powder. These recent developments highlight Johnson & Johnson’s ongoing activities in acquisitions, clinical trials, legal battles, and product efficacy.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
The fastest way to find out is with our Fair Value calculator. We use a mix of 17 proven industry valuation models for maximum accuracy. Get the bottom line for JNJ plus thousands of other stocks and find your next hidden gem with massive upside.