1 February 2026 - Pharming today announced that the US FDA has issued a complete response letter to its supplemental new drug application for Joenja (leniolisib), an oral, selective phosphoinositide 3-kinase delta inhibitor, as a treatment for children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome, a rare primary immunodeficiency.

The FDA raised an issue with the potential for underexposure in lower weight paediatric patients.

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