Johnson & Johnson presented Phase 2/3 ENERGY study results for Imaavy (nipocalimab) at the European Hematology Association 2026 Congress. The therapy targets warm autoimmune hemolytic anemia (wAIHA), a rare blood disorder with no current FDA-approved treatments.
The study met its primary endpoint, demonstrating statistically significant and durable hemoglobin improvements compared to a placebo. Mean hemoglobin levels improved as early as the first week of the study. The safety profile matched previous clinical findings for the drug.
These results support a supplemental Biologics License Application for Imaavy. The U.S. FDA has granted the submission Priority Review. Imaavy is positioned to potentially become the first-ever approved treatment for wAIHA.