Shots:
The US FDA has accepted sNDA & granted priority review to leniolisib for the treatment of children (4-11yrs.) with activated phosphoinositide 3-kinase delta (APKD) syndrome (PDUFA: Jan 31, 2026); regulatory review is ongoing in the EEA, Japan & Canada
sNDA was supported by a P-III trial in APKD pediatric pts (4-11yrs.), which showed reduced…
