Pharming Group (PHAR) announced that the European Commission granted marketing authorization for Joenja (leniolisib), an oral, selective phosphoinositide 3-kinase (PI3K) delta inhibitor, for the treatment of activated PI3K delta syndrome (APDS), a rare primary immunodeficiency, in adult and pediatric patients 12 years of age and older.
Joenja is the first and only approved treatment for APDS in the European Union (EU). The first European launch is expected in Germany in third quarter of 2026, with additional launches anticipated pending completion of national reimbursement negotiations.
The approval is valid across all 27 EU Member States, as well as Norway, Iceland and Liechtenstein. Joenja is currently marketed in the United States and the United Kingdom for patients aged 12 years and older with APDS.
Leniolisib is currently under regulatory review for the treatment of APDS in Canada and several other countries. Leniolisib is also being evaluated in two Phase II clinical trials in primary immunodeficiencies (PIDs) with immune dysregulation. The safety and efficacy of leniolisib has not been established for PIDs with immune dysregulation beyond APDS.
PHAR closed on May 22 at $12.60, down $0.21 or 1.64%. However, in after-hours trading the stock rebounded to $13.03, gaining $0.43 or 3.41%.
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