ENXTAM:PHARMBiotechs
Why Pharming Group (ENXTAM:PHARM) Is Down 16.3% After FDA Rejects Joenja Pediatric Expansion Plan
In early February 2026, Pharming Group reported that the U.S. FDA issued a Complete Response Letter for its supplemental New Drug Application seeking to extend Joenja’s use to children aged 4 to 11 years with APDS, requesting more pediatric pharmacokinetic data and clarification on a batch-testing analytical method.
An important angle for investors is that Joenja’s existing U.S. approval for patients aged 12 and older remains intact, while younger pediatric access now hinges on resolving...