Biopharmaceutical company Pharming Group N.V. (Euronext Amsterdam:PHARM) (NASDAQ:PHAR) announced on Friday that the European Commission has granted marketing authorisation for Joenja (leniolisib), an oral, selective phosphoinositide 3-kinase (PI3K) delta inhibitor, for the treatment of activated PI3K delta syndrome (APDS) in adult and paediatric patients aged 12 and older.

According to Pharming, Joenja is the first approved treatment for APDS in the European Union.

The first European launch is expected in Germany in the third quarter of 2026, with additional launches anticipated pending completion of national reimbursement negotiations. The approval applies across all 27 EU member states, as well as Norway, Iceland and Liechtenstein.

The authorisation was based on results from a multinational Phase II/III clinical trial involving 31 patients, which showed statistically significant improvements in markers of immune dysregulation and immunodeficiency. The submission also included long-term open-label extension data from 37 patients treated with leniolisib for a median of three years.

This approval adds to existing Joenja authorisations in the United States, United Kingdom, Japan, Australia and Israel, supporting Pharming's global expansion strategy.