Pharming Group N.V. announces that Pharming’s Chief Executive Officer, Sijmen de Vries, and Chief Commercial Officer, Stephen Toor, will attend the Guggenheim Healthcare Talks | Genomic Medicines and Rare Disease Days, April 3 - 4, 2023 in New York.

Pharming Group N.V. announces that the US Food and Drug Administration (FDA) has approved Joenja® (leniolisib) for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older. Joenja®, an oral, selective PI3Kδ inhibitor, is the first and only treatment approved in the US for APDS, a rare and progressive primary immunodeficiency.

Pharming Group N.V. presents its preliminary (unaudited) financial report for the full year ended December 31, 2022. Download the press release below.

Pharming Group N.V. is aware that the Federal Deposit Insurance Corporation (“FDIC”) has been appointed receiver of Silicon Valley Bank (“SVB US”) and that the Bank of England, barring any intervening events, intends to put Silicon Valley Bank UK Limited (“SVB UK”) into insolvency.

Pharming Group N.V. confirms it will announce its unaudited Full Year 2022 financial results for the year ended December 31, 2022, on Thursday, March 16, 2023.

The multinational Phase III study is evaluating leniolisib tablets in children aged 4 to 11 years with APDS, a rare primary immunodeficiency.

Pharming Group N.V. announces that the European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) has decided to shift its assessment of the Marketing Authorisation Application (MAA) for leniolisib to a standard review timetable.

V. Koneti Rao, MD, shared new evidence of long-term safety and hematologic response in patients who received leniolisib to treat APDS, a rare primary immunodeficiency. Interim analysis demonstrated leniolisib to be well tolerated and indicated the durability of the efficacy results seen in the Phase II/III randomized, controlled trial