Joenja (leniolisib) was approved by the FDA on September 11, 2026 for activated PI3K-delta syndrome (APDS) in children (resubmission covering patients weighing 27 kg or more).
Verified against: FDA action day September 11, 2026 (NDA 217759 S-006) · Announcement September 11, 2026 (sponsor announcement) · Goal date October 24, 2026 (Pharming 6-K).
Joenja (leniolisib) approved as the first treatment for children with activated PI3K-delta syndrome in the United States (Sep 11 2026).
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.
Primary source: Pharming Group 6-K, September 11, 2026
FDA record of the action: the FDA approved on September 11, 2026, per NDA 217759 S-006 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Yes. The FDA approved the application for Joenja (leniolisib) on September 11, 2026, per the FDA's own record. The primary source is linked on this page.
Joenja (leniolisib) is a Pharming Group N.V. (PHAR) program. The FDA decision came on September 11, 2026; the FDA's own record of the decision is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), PHAR moved -29.6%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.