Agios responds to analyst report on PYRUKYND safety data; Saudi Arabia approves PYRUKYND for thalassemia

AGIOS PHARMACEUTICALS, INC.

Analyst report on Aug 4, 2025 references four FAERS cases; Agios says benefit-risk profile unchanged.
Three cases reported to Agios: two for PK deficiency patients on commercial PYRUKYND, one expanded access for sickle cell.
Fourth case reported directly to FDA; Agios evaluating via pharmacovigilance processes.
Saudi FDA approved PYRUKYND for adult patients with alpha- or beta-thalassemia (both non-transfusion and transfusion dependent).

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