Core Viewpoint - Shares of Agios Pharmaceuticals (AGIO) fell 11% after the FDA extended the review timeline for the supplemental new drug application (sNDA) for Pyrukynd in thalassemia by three months, with a new decision date set for December 7, 2025 [1][7]. Company Developments - The sNDA for Pyrukynd is based on data from two phase III studies, ENERGIZE and ENERGIZE-T, aiming for approval in treating non-transfusion-dependent and transfusion-dependent thalassemia in adults [2]. - Agios submitted a proposed Risk Evaluation and Mitigation Strategy (REMS) to address liver injury risks, which led to the three-month extension of the review timeline [3]. - The FDA had previously expected a decision on September 7, 2025, and the delay may impact the commercial launch timeline, which was initially anticipated before the end of 2025 [8]. Financial Performance - Year-to-date, Agios shares have increased by 10%, outperforming the industry average rise of 4.1% [4]. - Pyrukynd generated sales of $21.2 million in the first half of 2025, marking a 26% year-over-year increase [9]. Ongoing Research - Agios is also conducting late-stage studies, ACTIVATE-Kids and ACTIVATE-KidsT, to evaluate Pyrukynd for treating PK deficiency in pediatric patients [10].