PHAR

Leniolisib (Joenja)

FDA PDUFA Target Action Date · Pharming Group N.V.

Saturday, October 24, 2026

108 days away

Drug Information

Drug Name: Leniolisib (Joenja) (CT.gov)
Application Type: sNDA (resubmission)
FDA Designations: Priority Review
Indication: Activated phosphoinositide 3-kinase delta syndrome (APDS) in children aged 4 to 11 years

Filing Details

Company: Pharming Group N.V.
Stock Ticker: PHAR
SEC CIK
Source: company press release (GlobeNewswire) + SEC Form 6-K →

What is a PDUFA Date?

A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.

Standard Review: 10 months from filing acceptance
Priority Review: 6 months from filing acceptance
Possible Outcomes: Approval, Complete Response Letter (CRL), or extension

Track All FDA Decisions

View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.

View FDA Calendar →

Data sourced from SEC EDGAR filings. Last updated: 2026-06-30. Report an issue