Market ExpansionThe global reach and addressable population for leniolisib continue to advance, with recent submissions and launches in markets like Japan and the U.K.
Regulatory ApprovalThe FDA accepted the sNDA seeking approval for leniolisib in children 4-11 years old with APDS, with a PDUFA date set for January 31, 2026.
Revenue GrowthTotal revenue guidance has been increased from $335-350 million to $365-375 million, reflecting continued growth across the commercial products.