Pharming Group N.V. announces the appointment of Jeroen Wakkerman as Chief Financial Officer (CFO), with effect from 16 November 2020.

Pharming Group N.V. today announces that the European Commission has granted orphan drug designation for leniolisib for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS), based on a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicine Agency (EMA).

Pharming Group N.V. announces the nomination of Barbara Yanni and Mark Pykett to its Board of Supervisory Directors. An Extraordinary General Meeting of Shareholders is expected to be convened later this year for their official appointment. Until that moment, Barbara Yanni and Mark Pykett will hold an observational role within Pharming’s Board of Supervisory Directors.

Pharming Group N.V. announces that it has received formal European Commission approval to treat acute hereditary angioedema (HAE) attacks in children with RUCONEST®. Following the positive opinion and recommendation from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on the extension of the indication for RUCONEST® received on 26 March 2020.

Pharming Group N.V. announces encouraging results from five patients with confirmed COVID-19 (SARS-CoV-2) infections hospitalized with related severe pneumonia that were treated with RUCONEST® (recombinant human C1 inhibitor) under a compassionate use program at the University Hospital Basel, Switzerland.

Pharming Group N.V. announces the Committee for Medicinal Products for Human Use (CHMP), an advisory committee of the European Medicine Agency (EMA), has adopted a positive opinion recommending an extension of the indication for RUCONEST® to the European Commission.

Pharming Group N.V. today announced that its Chief Financial Officer, Robin Wright, has decided (for family reasons) not to put himself up for re-election as a member of the Board of Management and thus as Chief Financial Officer at the upcoming General Meeting of Shareholders on 20 May 2020 and that, as result of this decision, his term with the Company will end as at that date.

Pharming Group N.V. today announced it has also received US Food and Drug Administration (FDA) approval of Pharming’s Prior Approval Supplement to add the new Netherlands production facility of starting material to the Biologics License Application (BLA) to support its lead product, RUCONEST®.

Pharming Group N.V. today announced it has received European Medicines Agency (EMA) approval of a Type II Variation for a new production facility for its lead product, RUCONEST®.

Pharming Group N.V. today announced it has entered into a definitive agreement with Swedish Orphan Biovitrum AB (publ) (“Sobi”) to reacquire the commercial rights to Pharming’s product, RUCONEST®, in all remaining territories, which includes all remaining EU markets. Under the agreement, the license is being terminated with effect from 1 January 2020 in all 36 countries with a smooth handover planned in the countries where Sobi has sales activities. Pharming will pay Sobi €7.5 million in two tranches.