Agios outlines 2024 milestones; positive Phase 3 mitapivat data in thalassemia; multiple potential approvals by 2026

AGIOS PHARMACEUTICALS, INC.

Phase 3 ENERGIZE study of mitapivat in non-transfusion-dependent thalassemia met primary endpoint (data Jan 3, 2024).
NDA for mitapivat in thalassemia planned by end of 2024; potential FDA approval in 2025.
Four additional Phase 3 readouts expected by end of 2025: ENERGIZE-T, ACTIVATE kids-T, RISE UP, ACTIVATE kids.
Potential FDA approvals: thalassemia 2025, sickle cell disease 2026, pediatric PK deficiency 2026.
Cash position expected to support operations and pipeline expansion at least into 2026.

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