FX.co ★ Agios Pharma Says EC Adopted Positive Decision For OMP Status Of Mitapivat In Sickle Cell Disease

Agios Pharmaceuticals, Inc. (AGIO) announced on Wednesday that the European Commission has issued a favorable decision regarding the orphan medicinal product designation for mitapivat, aimed at treating sickle cell disease. Notably, back in November 2020, the FDA had already granted orphan drug status to mitapivat for the same condition. The company anticipates unveiling the results from its Phase 3 RISE UP study on mitapivat in late 2025.