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PHAR PDUFA Date: Joenja

Page updated ·next FDA decision on the calendar ·Data as of Nov 12, 2026 2:24 AM ET
FDA decision (PDUFA) target Jan 30, 2027 · Pharming Group N.V. · Activated PI3K-delta syndrome (APDS), children aged 4 years and older weighing 13 kg or more (lower-dose formulation)
Source: Pharming 6-K 2026-09-25 (EX-99.1). “PDUFA target action date of January 30, 2027”

Key facts

FDA PDUFA target date2027-01-30
Drug / candidateJoenja (leniolisib)
IndicationActivated PI3K-delta syndrome (APDS), children aged 4 years and older weighing 13 kg or more (lower-dose formulation)
CompanyPharming Group N.V.
Market-cap tierSmall

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FAQ

When is the PHAR PDUFA date?
The FDA PDUFA target date for PHAR (Pharming Group N.V.) is 2027-01-30 for Joenja (leniolisib). Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is PHAR's drug Joenja?
Joenja (leniolisib) is Pharming Group N.V.'s candidate under FDA review for Activated PI3K-delta syndrome (APDS), children aged 4 years and older weighing 13 kg or more (lower-dose formulation).