An agreed PIP is the regulatory pathway to market authorization for leniolisib as a treatment of activated phosphoinositide 3-kinase delta syndrome in children

Pharming Group N.V. (“Pharming” or “the Company”) (Euronext Amsterdam: PHARM/NASDAQ: PHAR) announces the topline results from two randomized, open label, controlled, pilot clinical trials of patients hospitalized with COVID-19 treated with RUCONEST® (recombinant human C1 inhibitor) for the prevention of severe SARS-CoV-2 infection. The primary endpoint in both studies was disease severity on the 7-point WHO ordinal scale on Day 7.

Pharming Group N.V. announces that the first patient has been enrolled in a Phase IIb double-blind, randomized, controlled study to assess the efficacy of RUCONEST® (recombinant human C1 esterase inhibitor, or “rhC1INH”) for the prevention of acute kidney injury after non-ST elevation myocardial infarction at the University Hospital Basel, Switzerland.

Pharming Group N.V. announces that the first patient has been enrolled in a randomized, open label, parallel group, controlled, pilot clinical trial in up to 120 patients hospitalized with confirmed COVID-19 treated with RUCONEST® (recombinant human C1 inhibitor) for the prevention of severe SARS-CoV-2 infections at the Valley Hospital in Ridgewood, New Jersey in the United States.

Pharming Group N.V. today announces the publication of data in the peer-reviewed journal, Frontiers in Immunology, from a compassionate use program of five patients with confirmed COVID-19 (SARS-CoV-2) infections hospitalized with related severe pneumonia that were treated with RUCONEST® (recombinant human C1 inhibitor, conestat alfa) at the University Hospital Basel, Switzerland.

Pharming Group N.V. announces that the first patient has been enrolled in a randomized, controlled, investigator-initiated clinical trial in up to 150 patients for the treatment with RUCONEST® (recombinant human C1 inhibitor) of patients with confirmed COVID-19 (SARS-CoV-2) infections hospitalized with related severe pneumonia at the University Hospital Basel in Basel, Switzerland.

Pharming Group N.V. today announces that, following receipt of the Dutch investigating centre’s ethics committee approval, it is commencing a clinical study of the effects of its recombinant human C1 esterase inhibitor (rhC1INH), RUCONEST®, in patients with pre-eclampsia

Pharming Group N.V. today acknowledged presentation of the results from an investigator-initiated comparative study of therapies in acute attacks of hereditary angioedema (“HAE”).

Pharming Group N.V. announced positive results from a Phase II investigator-initiated study of RUCONEST® (recombinant human C1 esterase inhibitor, or “rhC1INH”) in a double-blind, placebo-controlled clinical trial in patients at risk of nephropathy resulting from contrast-enhanced examinations.