Leniolisib (Joenja)
FDA PDUFA Target Action Date · Pharming Group N.V.
Note: Resolves the auto-scraper parse-error row ('separate', Pharming Group, 2026-10-24) - the real drug is leniolisib (Joenja). FDA accepted the resubmitted sNDA on June 4, 2026 with PDUFA target action date Oct 24, 2026, following a Complete Response Letter received Jan 30, 2026 and a Type A meeting Mar 26, 2026; resubmission seeks 40 mg and 50 mg twice-daily dosing for pediatric patients weighing >=27 kg. Granted Priority Review. Leniolisib/Joenja is an oral selective PI3K-delta inhibitor and holds FDA Orphan Drug designation for APDS (rare primary immunodeficiency). Corresponding primary SEC filing: https://www.sec.gov/Archives/edgar/data/0001828316/000182831626000031/pharmingannouncesusfdaacce.htm
Drug Information
- Drug Name
- Leniolisib (Joenja) (CT.gov)
- Application Type
- sNDA (resubmission)
- FDA Designations
- Priority ReviewOrphan Drug
- 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
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