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Pharming Group receives positive CHMP opinion for Joenja® (leniolisib) for the treatment of APDS in adult and pediatric patients 12 years and older Pharming (EURONEXT:PHARM) announced a positive CHMP opinion recommending marketing authorization for Joenja (leniolisib) for treatment of APDS in patients aged 12 and older. A final European Commission decision is expected in Q2 2026, roughly two months after March 27, 2026.The recommendation is based on a randomized Phase II/III trial (31 patients) showing statistically significant improvements in immune dysregulation and immunodeficiency, and on long-term open-label data from 37 patients with median three-year exposure. Joenja is already approved in the United States, United Kingdom, and Japan.

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Pharming Group announces approval of Joenja® (leniolisib) in Japan for the treatment of APDS in patients aged 4 years and older First approved treatment in Japan for activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) Approval is based on positive Phase III data from multinational and Japanese studies in patients aged 12 years and older and a multinational pediatric study in children aged 4 to 11 years First

#PHARM Pharming Group announces approval of Joenja® (leniolisib) in Japan for the treatment of APDS in patients aged 4 years and older

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Pharming Group reports fourth quarter and full year 2025 financial results, delivering strong revenue growth and profitability with positive cash flow Pharming (Euronext:PHARM / Nasdaq:PHAR) reported strong 2025 results with total revenues up 27% to US$376.1m, driven by RUCONEST® and Joenja® growth. The company delivered US$25.8m operating profit and US$54.7m net cash from operations, and issued 2026 revenue guidance of US$405–425m.Key development milestones include Phase II leniolisib readouts in H2 2026 and expected FALCON enrollment completion for napazimone in 2026.

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