Johnson & Johnson (JNJ) announced the FDA has granted Priority Review to the supplemental Biologics License Application for IMAAVY as treatment for people living with warm autoimmune hemolytic anemia. The company noted that IMAAVY is the first therapy to receive FDA Priority Review for this condition. The FDA's decision is supported by results from the pivotal Phase 2/3 ENERGY study.
Leonard Dragone, Disease Area Leader, Autoantibody and Rheumatology, Johnson & Johnson, said: "This designation highlights both the serious, life-threatening nature of wAIHA and the potential for IMAAVY, if approved, to help address a critical unmet need by delivering clinically meaningful outcomes for patients."
In pre-market trading on NYSE, Johnson & Johnson shares are down 0.03 percent to $227.38.
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April 24, 2026 15:15 ET Economics news flow was relatively light this week even as the conflict in the Middle East continued, raising concerns for policymakers. In the U.S., spending data, initial jobless claims and pending home sales were the highlights. Business confidence in the biggest euro area economy was in focus in Europe. Inflation data from Japan gained attention in Asia.