Agios Pharmaceuticals’ stock rallied after the company announced its intention to seek accelerated approval for its lead drug, mitapivat, for the treatment of sickle cell disease (SCD), following a pre-supplemental new drug application (sNDA) meeting with the FDA. As per the discussion with the FDA, Agios submitted its proposed confirmatory clinical study design for review. The company plans to submit the sNDA for mitapivat in SCD in the coming months and is closely engaged with the FDA to align on the requirements for the confirmatory study needed to support accelerated approval.