Leniolisib PDUFA date: FDA decision expected January 30, 2027
The FDA is expected to decide on Leniolisib from Pharming Group N.V. in Activated phosphoinositide 3-kinase delta syndrome (APDS) in children aged 4 years and older weighing 13 kg to 27 kg by the PDUFA target action date of January 30, 2027. For Activated phosphoinositide 3-kinase delta syndrome (APDS) in children aged 4 years and older weighing 13 kg to 27 kg. 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 16, 2026. Confirm dates against the company's or the FDA's announcement before acting.
Questions about this FDA decision
- When is the PDUFA date for Leniolisib?
- The FDA's PDUFA target action date for Leniolisib is January 30, 2027. 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 phosphoinositide 3-kinase delta syndrome (APDS) in children aged 4 years and older weighing 13 kg to 27 kg.
- 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).