Leniolisib

October 22, 2026: Pharming Group N.V. (NASDAQ: PHAR) pre-announced Q3 2026 results and moved its full Q3 financial results/business update to October 27, 2026 from November 5, 2026. Preliminary Q3 revenue was about US$117.6 million, up 21% year over year, with RUCONEST contributing US$93.8 million (+14%) and Joenja US$23.8 million (+58%). The company tightened 2026 revenue guidance to US$380 million-US$390 million and lowered operating expense guidance to US$310 million-US$315 million.

Clinical updates:

• Leniolisib/Joenja: At ESID 2026, Pharming presented positive Phase II data in genetically defined primary immunodeficiencies with immune dysregulation linked to PI3Kδ signaling. Topline Phase II results from a separate CVID trial are expected in November 2026. The company is working toward a single registrational Phase III trial in broader CVID.
• Napazimone (KL1333): In mtDNA-driven mitochondrial disease, the pivotal FALCON trial is expected to have about 145 of 180 planned subjects enrolled by year-end 2026. Enrollment is now expected to complete in 1H 2027, with topline results expected about one year after enrollment completion.