Pharming says FDA accepted resubmission of Joenja pediatric sNDA

Pharming said the U.S. Food and Drug Administration has accepted its resubmitted supplemental new drug application for Joenja (leniolisib) in children ages 4 to 11 with activated PI3K delta syndrome, or APDS.

The company said the filing covers 40 mg and 50 mg twice-daily dosing for pediatric patients weighing at least 27 kilograms. The FDA set a target action date of October 24, 2026, restarting the review clock for the application.

The resubmission follows a Complete Response Letter the agency issued on January 30, 2026. Pharming then held a Type A meeting with the FDA on March 26, 2026 to discuss the issues raised in that letter.

What happens next

The new PDUFA date gives investors and patients a clearer timeline for a possible label expansion, but it does not indicate whether the FDA will approve the application. Pharming also said it plans to file a separate sNDA later in 2026 for lower-weight pediatric patients.

The latest regulatory step is a positive development for Joenja, which is already used in APDS, a rare immune disorder.