Agios Ends Tebapivat Program in Sickle Cell Disease, Focuses on Mitapivat
Agios Pharmaceuticals announced it will not advance tebapivat in sickle cell disease after Phase 2 results failed to show a differentiated profile.
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Agios Wins FDA Priority Review for First Oral PK Activator in Sickle Cell Disease
PDUFA target date is November 1, 2026. If approved, it would be the first oral PK activator for SCD patients.
Agios Stops Tebapivat for LR-MDS – But It’s Still Moving Forward for Sickle Cell Disease
Agios scraps LR-MDS drug tebapivat after weak results but continues sickle cell trials; safety was good.
Agios Pharma Shares Crash as Novo Nordisk Posts Strong Phase 3 Sickle Cell Results
Novo Nordisk’s new pill cuts sickle cell pain crises, boosting outcomes and sending Agios Pharma shares down after strong trial results.
Agios Moves Closer to Fast FDA Approval for New Sickle Cell Pill
Agios is pursuing accelerated FDA approval for mitapivat, a new oral pill for sickle cell disease. The RISE UP trial showed better hemoglobin levels, fewer pain crises, and good safety.
FDA Approves AQVESME: First Treatment for Thalassemia Anemia
The FDA has approved Agios’ AQVESME (mitapivat), the first medicine for treating anemia in adults with alpha or beta-thalassemia, offering hope for thousands of patients.