Upcoming FDA decision · October 24, 2026
Leniolisib PDUFA date: FDA decision expected October 24, 2026
6 days to goPharming Group N.V. (PHAR) →
The FDA is expected to decide on Leniolisib from Pharming Group N.V. in Activated PI3K delta syndrome (APDS) in pediatric patients aged 4 to 11 years by the PDUFA target action date of October 24, 2026. For Activated PI3K delta syndrome (APDS) in pediatric patients aged 4 to 11 years. sNDA filing. Extracted from SEC filing: 6-K
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: sec.gov · Data checked October 18, 2026. Confirm dates against the company's or the FDA's announcement before acting.
October 24
Target action date
Phase 3
Stage
Verified
Date confidence
—
FDA designations
Questions about this FDA decision
- When is the PDUFA date for Leniolisib?
- The FDA's PDUFA target action date for Leniolisib is October 24, 2026. The FDA can act before that date, and the review can be extended.
- What is Leniolisib being reviewed for?
- The application under FDA review covers Activated PI3K delta syndrome (APDS) in pediatric patients aged 4 to 11 years.
- Which company is developing Leniolisib?
- Pharming Group N.V. (PHAR).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).