FDA approval for Grifols' Xembify

5 July 2019

Spanish drugmaker Grifols (GRF: MC) says that Xembify,its new 20% subcutaneous immunoglobulin, has been approved by the US Food and Drug Administration.

Xembify is used to treat primary immunodeficiencies, and news of the marketing clearance pushed the plasma-derived medicines firm’s share price up 1.31% to 27.10 euros by close of trading on Thursday. The stock rose a further 2% to 27.63 euros today.

The FDA approval marks the culmination of an important R+D+i initiative for Grifols, as well as an opportunity to enhance the Bioscience Division's product portfolio. Grifols is currently a market leader in the production and marketing of immunoglobulins, with 30.3% market share (grams) in the USA. Thus, this approval reinforces Grifols' commitment to patients in the USA, allocating an increasing part of its production to supply the needs of this market.

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