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Pharming Group N.V. develops and commercializes medicines for rare and ultra-rare diseases, with news focused on RUCONEST®, Joenja® (leniolisib) for activated phosphoinositide 3-kinase delta syndrome, and the company's rare-disease pipeline. Updates commonly cover clinical studies, market authorizations, commercial launches, licensing economics, product revenue trends, and management presentations at healthcare investor conferences.
The company operates as a global biopharmaceutical issuer listed on Euronext Amsterdam and Nasdaq. Recurring coverage also includes financial results, regulatory interactions in major markets, and development programs involving small molecules, biologics, protein replacement therapies, and precision medicines for immunological and genetic conditions.
Pharming Group N.V. has received a positive decision from the UK's MHRA regarding its Paediatric Investigation Plan (PIP) for leniolisib, aimed at treating activated phosphoinositide 3-kinase delta syndrome (APDS) in children aged 1 to under 18. Additionally, leniolisib has been granted Promising Innovative Medicine (PIM) designation, enabling potential access through the MHRA's Early Access to Medicines Scheme. The PIP includes two planned global clinical trials, with recruitment expected to begin in the second half of 2022. Pharming aims to file for global registration and launch leniolisib in the US and Europe in 2023.
Pharming Group N.V. announced positive data from the Phase II/III trial of leniolisib for activated phosphoinositide 3-kinase delta syndrome (APDS) at the Clinical Immunology Society (CIS) 2022 Annual Meeting. The trial met its co-primary endpoints, showing a significant reduction in lymph node size and an increase in naive B cells among treated patients. The study drug was well-tolerated with no treatment-related serious adverse events. Pharming plans to submit global regulatory filings for leniolisib in Q2 2022 and aims for U.S. and European launches in 2023.