The FDA has assigned a PDUFA goal date of March 29, 2023 for the NDA submission based on randomized-controlled and long-term extension data for leniolisib as a treatment for APDS, a rare primary immunodeficiency.

Pharming Group N.V. announces that its Chief Executive Officer, Sijmen de Vries, will present at the H.C. Wainwright 24th Annual Global Investment Conference, a hybrid meeting based in New York, at the Lotte Palace Hotel, September 12-14, 2022.

Pharming Group N.V. presents its preliminary (unaudited) financial report for the first six months of 2022 ended June 30, 2022.

Pharming Group N.V. announces that a new diagnosis code for reporting cases of activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency, will be added to the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) by the US Centers for Disease Control and Prevention (CDC). The diagnosis code, D81.82 ‒ Activated Phosphoinositide 3-kinase Delta Syndrome (APDS), will be effective starting October 1, 2022.

Pharming Group N.V. announces that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted an accelerated assessment for the Marketing Authorisation Application (MAA) for leniolisib. Leniolisib has been studied for the treatment of activated PI3K delta syndrome (APDS), a rare primary immunodeficiency, in adults and adolescents age 12 or older in the European Economic Area (EEA). Pharming is on track and plans to submit its MAA for leniolisib to the EMA in October 2022.

Pharming confirms it will announce financial results for the six months ended 30 June 2022 on Thursday, August 4, 2022.

Pharming announces that its Chief Executive Officer, Sijmen de Vries, will present at the Jefferies Healthcare Conference 2022, a hybrid meeting based in New York, at 22:00-22:30 CET/16:00-16:30 EDT on 9 June 2022.

Pharming Group N.V. announces that at its Annual General Meeting of shareholders (AGM), held today, all proposals were approved.  

Pharming Group N.V. presents its (unaudited) financial report for the first quarter of the year ended 31 March 2022.

Pharming confirms it will announce financial results for the first quarter of the year ended 31 March 2022 on Thursday, 12 May 2022.