J&J reports data from Phase II/III ENERGY trial for wAIHA 12.06.2026

Johnson & Johnson has released initial results from the Phase II/III ENERGY trial, demonstrating that Imaavy (nipocalimab-aahu) significantly improves haemoglobin (Hgb) levels in adults with warm autoimmune haemolytic anaemia (wAIHA). In this randomised, double-blind study of 115 patients, those receiving a 30mg/kg dose showed a durable Hgb response by week 24, with nearly three times as many patients achieving the primary endpoint compared to the placebo group. Nearly two-thirds of treated patients reached an Hgb ≥10g/dL and a ≥2g/dL rise from baseline. Secondary endpoints revealed reduced steroid use and decreased fatigue starting at week two. The safety profile was consistent with previous myasthenia gravis treatments, with common side effects including peripheral oedema, diarrhoea, and fever. This is particularly significant as there are currently no FDA-approved therapies for wAIHA, which is typically managed with unapproved corticosteroids.













