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Pharming (PHAR) announced the first commercial shipments of Joenja to patients in the United States. Joenja, an oral, selective PI3Kdelta inhibitor, is the first and only treatment approved in the U.S. for activated phosphoinositide 3-kinase delta syndrome, or APDS, a rare and progressive primary immunodeficiency, in adult and pediatric patients 12 years of age and older. Under the terms of Pharming's 2019 exclusive license agreement with Novartis (NVS) for leniolisib, the corresponding first commercial sale of Joenja triggers a $10M milestone payment by Pharming to Novartis.

Shares of Pharming are up $2.45, or 22%, to $13.73 after the company announced that the Food and Drug Administration has approved Joenja for the treatment of activated phosphoinositide 3-kinase delta syndrome, or APDS, in adult and pediatric patients 12 years of age and older.

Pharming Group announced that the US Food and Drug Administration has approved Joenja for the treatment of activated phosphoinositide 3-kinase delta syndrome in adult and pediatric patients 12 years of age and older. Joenja, an oral, selective PI3Kdelta inhibitor, is the first and only treatment approved in the US for APDS, a rare and progressive primary immunodeficiency. The FDA evaluated the Joenja application for APDS under Priority Review, which is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Joenja is expected to launch in the US in early April and will be available for shipment in mid-April.