Agios outlines 2026 milestones: AQVESME launch in thalassemia, potential sNDA for sickle cell disease

AGIOS PHARMACEUTICALS, INC.

AQVESME (mitapivat) U.S. approval in thalassemia Dec 2025; commercial launch underway, product available late Jan 2026.
Pre-sNDA meeting with FDA for mitapivat in sickle cell disease expected Q1 2026; U.S. submission to follow.
Pipeline: tebapivat Phase 2 sickle cell topline H2 2026; Phase 2b LR-MDS topline H1 2026.
AG-236 (siRNA for PV) Phase 1 healthy volunteer topline H1 2026; AG-181 Phase 1b PKU trial init H1 2026.
Target >$1B peak global sales from existing thalassemia and PK deficiency commercial presence.

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