PHAR PDUFA Date: Joenja

Name: Joenja FDA decision
Start: 2027-01-30
End: 2027-01-30

Updated September 27, 2026·next FDA decision on the calendar

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)

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).