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Pharming announces that a positive decision has been made by the European Medicines Agency (EMA) on the Paediatric Investigation Plan (PIP) for leniolisib, a phosphoinositide 3-kinase (PI3K) inhibitor, currently in development for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS).

The approval of the PIP further supports our confidence in the potential of leniolisib to address this orphan disease and population and provides us with a pathway towards marketing approval in Europe, in parallel with our US regulatory strategy.

- Anurag Relan - Chief Medical Officer
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