Joenja (leniolisib) approved as the first treatment for children with activated PI3K-delta syndrome in the United States (Sep 11 2026).
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (3/20/26) through T+1. Run-up high $17.8 on 4/15/26, low $9.82 on 8/3/26 (T-120 to T-1). FDA decision 9/11/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-09-11
OutcomeApproved
Drug / candidateJoenja (leniolisib)
IndicationActivated PI3K-delta syndrome (APDS) in children
CompanyPharming Group N.V.
Market-cap tierSmall
120-day run-up (T-120→T-1)-29.6%
Cohort decision-day move (history)3.6% median (n=280)
The PDUFA goal date was October 24, 2026 and the FDA approved on September 11, 43 days early. Pharming stated that goal date in its 6-K of June 4, 2026. The application was a resubmission that added data the FDA had requested on analytical methods used for production batch testing, and it covers paediatric patients weighing 27 kg or more; Pharming has said a separate sNDA for lower doses in patients under 27 kg is planned.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
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