Agios Pharmaceuticals Inc. (NASDAQ: AGIO) shares jumped 18% on Thursday after the company received U.S. Food and Drug Administration approval for mitapivat, marketed as AQVESME, prompting BofA Securities to raise its price target to $34 from $32 while maintaining a Buy rating.
BofA said mitapivat became the only therapy approved for both transfusion-dependent and non-transfusion-dependent alpha- and beta-thalassemia. The firm noted that, despite delays around the PDUFA date, confidence in approval had been high, supported by prior regulatory clearance in Saudi Arabia and a favorable opinion from the European Medicines Agency’s CHMP.
The analyst said the drug’s REMS requirements and black box warning related to hepatocellular injury were consistent with expectations based on company commentary and were not expected to materially hinder adoption. Launch execution in thalassemia, with availability anticipated in late January 2026, was expected to be a major focus for 2026 performance.
BofA modeled peak sales of approximately $1 billion for the thalassemia indication and said initial uptake could be gradual given the time required for REMS certification. Following approval, the firm raised its probability of success in thalassemia to 100% from 85% and modestly increased its peak market share assumptions.
