Joenja® (leniolisib) — Topline data
H2 2026
Patient enrollment in both clinical trials is now complete and we anticipate trial read-outs in the second half of 2026.Source filing
PHAR biotech catalysts & pipeline
PHARMING GROUP NV · Data as of 2026-09-08
Upcoming catalysts
Joenja® (leniolisib) — NDA/BLA submission
H2 2026
• Separate sNDA for lower weight pediatric patients planned for second half 2026Source filing
Joenja® (leniolisib) — Topline data
Q4 2026
Plans to report clinical data with leniolisib in significantly larger CVID patient populations in the fourth quarter 2026Source filing
Joenja® (leniolisib) — PDUFA
Oct 24
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 24, 2026.Source filing
KL1333 — Topline data
late 2027
The program remains on track to complete enrollment this year, with trial readout anticipated in late 2027 and potential FDA approval by the end of 2028, if successful.Source filing
KL1333 — PDUFA
Late 2028
We continue to anticipate trial read-out in 2027 with potential FDA approval by end of 2028.Source filing