PHAR Stock Discussion (Pharming Group N.V.)

Pharming secures priority review for lower-dose pediatric Joenja

Pharming ($PHAR) said the FDA accepted its supplemental application for a lower-dose Joenja formulation and granted priority review. The proposed expansion addresses patients aged four and older with activated PI3K delta syndrome who weigh between 13 and 27 kilograms. The agency’s target decision date is January 30, 2027, giving the company a defined timetable for the assessment. The filing is supported by an open-label, single-arm Phase 3 pediatric study evaluating lymph-node enlargement and im

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Pharming expands Joenja approval to younger children with APDS

Pharming ($PHAR) secured FDA approval to use Joenja in children aged four to 11 with activated PI3K delta syndrome who weigh at least 27 kilograms. The expansion adds younger patients to the medicine’s existing indication for older patients. The company expects the new pediatric presentations to become available in October. The supporting pediatric study was open-label and assessed treatment over 12 weeks, reporting reductions in lymph-node size and improvements in immune-cell measures. Reported