After a regulatory success in thalassemia, Agios is preparing to present mixed Phase III Rise Up data for mitapivat and tebapivat to the FDA as it seeks full approval in sickle‑cell disease, the company said. Agios aims to leverage prior indications to broaden clinical labels in rare hematology. Mitapivat and tebapivat are small molecules that modulate red‑cell metabolism; gaining an SCD indication would expand treatment options in a field dominated by newer biologics and gene therapies. Agios’ strategy underscores the incremental path rare‑disease developers use to expand market access across related hemoglobinopathies.