Pharming Group N.V. announces today an update on the ongoing review of its Marketing Authorisation Application (MAA) for leniolisib for the treatment of adult and pediatric patients 12 years of age and older with activated phosphoinositide 3-kinase delta syndrome (APDS) by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

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

Pharming Group N.V. announces that the Company’s 2024 Annual General Meeting of Shareholders (the “AGM”) will be held on Tuesday, May 21, 2024 at 14:30 CEST.

Pharming Group N.V. announces that it has received a Day 180 Second List of Outstanding Issues (LoOI) from the European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) regarding its Marketing Authorisation Application (MAA) for leniolisib for adult and pediatric patients 12 years of age and older with APDS, a rare primary immunodeficiency. Based on the timetable included in the CHMP Day 180 Second LoOI, and considering the CHMP’s decision to reschedule the Ad-Hoc Expert Group (AEG) meeting to the end of November, Pharming now expects the CHMP to issue its opinion on the leniolisib MAA in the first quarter of 2024.

Pharming Group N.V. announces today that the Extraordinary General Meeting of Shareholders (EGM) has adopted all proposals on the EGM agenda.

Pharming Group N.V. announces today that the Board of Directors has nominated Dr. Richard Peters to become Pharming’s new Chairman.

Pharming Group N.V. announces that the Company’s 2023 Annual General Meeting of Shareholders (AGM) will be held on Wednesday, May 17, 2023, at 14:00 CEST.

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

Pharming announces the filing of its Annual Report for the year ended 31 December 2021. The Company has also filed its Form 20-F with the U.S. Securities and Exchange Commission (SEC) for the same period. In addition, the company convenes its 2022 AGM.