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Pharming Group N.V.
Video analysis: PHGUF
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News: PHGUF
FDA approves Pharming's Joenja® as first treatment for children with APDS in the U.S.
FDA approval expands Joenja indication to include children with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) ages 4 to 11 who weigh at least 27kg Newly approved Joenja doses are expected to be available in October Leiden, the Netherlands, September 11, 2026: Pharming (Euronext Amsterdam: PHARM/Nasdaq: PHAR), a global biotechnology company focused on rare immune and genetic diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for 40 mg and 50 mg twice-daily dosing of Joenja® (leniolisib), an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, as a treatment for children aged 4 to 11 years weighing at least 27 kg with activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency. With this approval, Joenja becomes the first FDA-approved treatment for children aged 4 to 11 years with APDS in the U.S. The newly approved Joenja doses are expected to be available to eligible pediatric patients in the U.S. in October through Pharming's established specialty distribution network and patient-support infrastructure.
Pharming Group to participate in Canaccord Genuity 46th Annual Growth Conference
Leiden, the Netherlands, August 4, 2026: Pharming Group N.V. (Euronext Amsterdam: PHARM/Nasdaq: PHAR), today announced its participation in the Canaccord Genuity 46th Annual Growth Conference in Boston on August 12-13, 2026.
