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Activated Phosphoinositide 3-Kinase δ Syndrome (APDS)
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Pharming Group announces U.S. FDA acceptance and Priority Review of supplemental New Drug Application for leniolisib in children with APDS aged 4 to 11 years
Globenewswire· 2025-10-01 05:00
If approved, leniolisib will be first and only treatment indicated for children with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS), a rare primary immunodeficiencyDecision based on positive data from multinational Phase III study in children aged 4 to 11 years with APDSPDUFA target action date of January 31, 2026 Leiden, the Netherlands, October 1, 2025: Pharming Group N.V. (“Pharming” or “the Company”) (Euronext: PHARM; Nasdaq: PHAR) today announced that the U.S. Food and Drug Administr ...