FDA slaps CRL on Pharming’s sNDA for Joenja

Dutch biopharma company Pharming Group (Euronext: PHARM) saw its shares tumble 13.5% to 1.48 euros this morning after it received a regulatory setback.

The company revealed that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to its supplemental New Drug Application (sNDA) for Joenja (leniolisib), an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, as a treatment for children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency.