Pharming Group N.V. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Pharming’s supplemental Biologics License Application (sBLA) for RUCONEST® [Recombinant Human C1 Esterase Inhibitor/ conestat alfa] for routine prophylaxis to prevent attacks in adult and adolescent patients with hereditary angioedema (HAE).

Pharming Group N.V. today announced that it has submitted a supplemental Biologics License Application (BLA) to the U.S. Food and Drug Administration (“FDA”) for RUCONEST® [Recombinant Human C1 Esterase Inhibitor/ conestat alfa] for routine prophylaxis to prevent attacks in adult and adolescent patients with hereditary angioedema (“HAE”).

Pharming Group N.V in association with HAEi, the international umbrella organization for the world’s Hereditary Angioedema (HAE) patient groups, announce the appointment of Inceptua Medicines Access as their new distribution partner for the “HAEi Global Access Program” (HAEi GAP).

Pharming Group N.V. announced today that it has concluded its End-of-Phase 2 interactions with the U.S. Food and Drug Administration (FDA).

Pharming Group N.V. today announced The Lancet has published data from a Phase II, double-blind, placebo-controlled, randomized clinical trial (NCT02247739) evaluating the efficacy and safety of RUCONEST® (C1 esterase inhibitor [recombinant]) for the prevention of hereditary angioedema (HAE) attacks.

Pharming Group N.V. today announces that it has completed a definitive agreement to acquire all North American commercialisation rights for its own product, RUCONEST® (recombinant human C1 esterase inhibitor), including all rights in the US, Mexico and Canada, from certain subsidiaries of Valeant Pharmaceuticals International, Inc. (“Valeant”) (NYSE/TSX: VRX).

Pharming Group N.V. today announced that it has closed a new financing round, comprising three financial instruments and a rights issue, providing a total of €104 million before costs.