Agios Provides Update on U.S. PDUFA Goal Date for PYRUKYND® (mitapivat) in Thalassemia
1. FDA extended PYRUKYND sNDA goal date to December 7, 2025. 2. REMS submission led to the extension, not new safety data. 3. CEO remains confident in PYRUKYND's benefit-risk profile. 4. Approximately 6,000 adults in the U.S. have thalassemia. 5. Ongoing trials show promise for treatment efficacy and safety.