Core Viewpoint - Agios Pharmaceuticals received FDA approval for mitapivat (AQVESME), leading to an 18% increase in share price and a price target raise by BofA Securities from $32 to $34 while maintaining a Buy rating [1] Group 1: FDA Approval and Market Impact - Mitapivat is now the only approved therapy for both transfusion-dependent and non-transfusion-dependent alpha- and beta-thalassemia [2] - Despite delays around the PDUFA date, confidence in the approval was high due to prior regulatory clearance in Saudi Arabia and a favorable opinion from the European Medicines Agency's CHMP [2] Group 2: Drug Launch and Sales Projections - The drug's REMS requirements and black box warning related to hepatocellular injury are consistent with expectations and are not anticipated to significantly hinder adoption [3] - The launch execution for thalassemia is expected to be a major focus for 2026, with availability anticipated in late January 2026 [3] - BofA projected peak sales of approximately $1 billion for the thalassemia indication, with initial uptake expected to be gradual due to REMS certification requirements [4] Group 3: Probability of Success and Market Share - Following the approval, BofA raised the probability of success in thalassemia to 100% from 85% and modestly increased peak market share assumptions [4]