Pharming Group NV

Pharming Group announces U.S. FDA acceptance and Priority Review of supplemental New Drug Application forleniolisib in children with APDS aged 4 to 11 years

If approved, leniolisib will be first and only treatment indicated for children with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS), a rare primary immunodeficiency Decision based on positive data from multinational Phase III study in childrenaged 4 to 11 years with APDS PDUFA target action date of January 31, 2026. 1 October 2025 -- Leiden,...

Pharming receives positive recommendation from NICE for Joenja▼(leniolisib) as a treatment for APDS

Joenja® is the first and only medicine specifically for APDS to be reimbursed within the NHS Recommended for adult and pediatric patients 12 years of age and older with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS). 23 April 2025 -- Leiden, the Netherlands -- Pharming Group N.V. announces that the National Institute for Health and...

Pharming Group announces first patient dosed in Phase II clinical trial of leniolisib for common variable immunodeficiency (CVID) with immune dysregulation

Multi-center clinical trial includes sites located in the US, UK and EU Second Phase II clinical trial studying leniolisib for additional primary immunodeficiencies (PIDs) CVID patients demonstrate clinical phenotypes similar to APDS, with global prevalence estimated at approximately 39 per million. 20 March 2025 -- Leiden, the Netherlands -- Pharming Group announces that the first...
Pharming Group N.V. Vondellaan 47 2332 AA Leiden The Netherlands

+31 (0)71 5247 400