Pharming's Joenja Edges Closer To Becoming First EU-Approved APDS Treatment After Positive CHMP Opinion With European Commission Decision Due Q2 2026

Pharming's Joenja (leniolisib) is on track to become the first EU-approved treatment for activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, following a positive opinion from the CHMP. This decision is based on Phase II/III clinical data showing significant improvements in immune dysregulation and immunodeficiency. The final decision from the European Commission is anticipated in Q2 2026.