Pharming Group N.V.
Joenja
APDS
Resolved
158days ago
FDA decision · Jan 30, 2026
What's at stake
An FDA complete response letter on Joenja for APDS is in focus around Jan 30, 2026.
Primary source
· SEC 6-K
verified 12h ago
“we received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding our supplemental New Drug Application (sNDA) for Joenja® (leniolisib) for the treatment of APDS in children aged 4 to 11 years.”