Pharming leaps on news of FDA nod for Joenja as first APDS therapy

The US Food and Drug Administration (FDA) has approved Joenja (leniolisib) for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older, Dutch biotech firm Pharming (Euronext: PHARM) announced late Friday.

The FDA nod, which came a few days ahead of the March 29 action date, sent Pharming’s US traded shares soaring 33%, to end the day at $14.96.

Joenja, an oral, selective PI3Kδ inhibitor, is the first and only treatment approved in the USA for APDS, a rare and progressive primary immunodeficiency.