Pharming says FDA accepted resubmitted Joenja sNDA for children 4 to 11 with APDS

Pharming said the U.S. Food and Drug Administration has accepted its resubmitted supplemental new drug application for Joenja (leniolisib) in children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome (APDS).

The company said the FDA assigned a PDUFA target action date of October 24, 2026, restarting the agency’s review of the application. The filing follows a complete response letter issued on January 30, 2026.

Joenja is currently approved in the U.S. for adult and pediatric patients 12 years and older with APDS, so the resubmitted application seeks to extend the label to a younger age group.

Pharming said the resubmission covers 40 mg and 50 mg twice-daily dosing for pediatric patients weighing 27 kg or more. The company also said it plans to submit a separate sNDA for lower-weight pediatric patients in the second half of 2026.

The FDA’s acceptance does not mean approval, but it moves the application back into the agency’s formal review process. The next major catalyst is the October 24, 2026 target date.