Pharming says FDA accepts Joenja sNDA resubmission for APDS in children aged 4-11

• Pharming won FDA acceptance of a resubmitted sNDA for Joenja to treat children aged 4-11 with APDS, expanding use beyond the current 12+ label.
• Phase III pediatric study results were already presented, showing broad clinical improvements with no serious drug-related safety issues reported.
• The filing seeks clearance for twice-daily dosing in patients weighing at least 27 kg, targeting a meaningful share of the pediatric population.
• FDA set an Oct. 24, 2026 PDUFA action date, a key catalyst for potential US pediatric market expansion.
• A separate filing for lower-weight children is planned for the second half of 2026, extending the addressable population if cleared.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Pharming Group NV published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202606040100OMX_____CNEWS_EN_GNW1001185778_en) on June 04, 2026, and is solely responsible for the information contained therein.