FDA grants Priority Review to IMAAVY for warm autoimmune hemolytic anemia, shortening review to about six months

The FDA granted Priority Review to J&J's supplemental BLA for IMAAVY (nipocalimab-aahu) in warm autoimmune hemolytic anemia. Priority Review shortens the review timeline to about six months, which puts a decision in the second half of 2026. The company said full efficacy results will be presented at an upcoming medical conference.

• FDA Priority Review granted to the wAIHA supplemental BLA
• Review timeline shortened to about six months
• Pivotal basis: Phase 2/3 ENERGY study, placebo-controlled
• Full results to be presented at an upcoming medical conference