Agios announces 2025 milestones: PYRUKYND PDUFA Sept 7; RISE UP topline in late 2025

AGIOS PHARMACEUTICALS, INC.

FDA accepted sNDA for PYRUKYND in thalassemia; PDUFA goal date September 7, 2025.
Phase 3 RISE UP topline results expected late 2025; potential U.S. commercial launch in 2026.
Received $1.1B in milestone payments: $905M from Royalty Pharma, $200M from Servier post vorasidenib approval.
Phase 3 ACTIVATE-Kids topline in early 2025; Phase 2b tebapivat enrollment completion late 2025.
IND filing planned for AG-236 siRNA in polycythemia vera mid-2025.

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