PHAR biotech catalysts & pipeline

PHARMING GROUP NV · Data as of 2026-10-25

Upcoming catalysts

Joenja® (leniolisib) — Topline data

Nov 2026

At ESID 2026, Pharming presented positive Phase II data for leniolisib in patients with genetically defined primary immunodeficiencies (PIDs) with immune dysregulation linked to PI3Kδ signaling; Pharming expects topline Phase II results from its separate trial in CVID patients with immune dysregulation, with or without an identified genetic cause, in November 2026.

Source filing

Joenja® (leniolisib) — PDUFA

Jan 30

The application has been granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2027.

Source filing

Napazimone (KL1333) — Clinical data readout

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

Napazimone (KL1333) — PDUFA

Late 2028

We continue to anticipate trial read-out in 2027 with potential FDA approval by end of 2028.

Source filing

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