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Agios Pharmaceuticals (AGIO) investor relations material
Agios Pharmaceuticals FDA Announcement summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.FDA Announcement summary24 Dec, 2025
Introduction and purpose
FDA approved mitapivat (Aqneusa/AQVESME) as the first and only oral therapy for anemia in adults with alpha or beta thalassemia, regardless of transfusion status, marking a significant milestone for patients with limited options and addressing a major unmet need.
The approval covers both non-transfusion-dependent and transfusion-dependent thalassemia patients, targeting a broad population.
Details of approval or decision
Approval is based on two global, placebo-controlled Phase 3 trials: ENERGIZE (non-transfusion-dependent) and ENERGIZE-T (transfusion-dependent), both meeting primary and key secondary endpoints.
The U.S. commercial launch targets 4,000 addressable patients out of 6,000 diagnosed adults, with a $425,000 annual WAC price.
Aqneusa/AQVESME will be marketed under a distinct brand name for regulatory clarity and REMS requirements.
Impact on industry and stakeholders
Represents the first disease-modifying therapy for non-transfusion-dependent thalassemia and the first approved therapy for alpha thalassemia, with high physician interest and strong value proposition.
86% of surveyed physicians plan to prescribe within six months of availability; REMS requirements are not seen as a significant barrier.
Launch is expected to deliver $1bn global peak-year sales across PKD and thalassemia indications.
AQVESME REMS impact on market penetration?
Unmet need for non-transfusion-dependent patients?
How will liver injury risk affect long-term use?
Axazeni: How will REMS impact initial patient starts?
Drivers to expand beyond 4K initial patients?
SCD label: Path to avoid Axazeni REMS/BBW?
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Next Agios Pharmaceuticals earnings date
Q4 202512 Feb, 2026
Next Agios Pharmaceuticals earnings date
Q4 202512 Feb, 2026
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Agios Pharmaceuticals Inc. is a biopharmaceutical company focused on discovering and developing therapies for genetically defined diseases. The company leverages its expertise in cellular metabolism and genetic pathways to create treatments for rare and severe conditions, including metabolic and hematologic disorders. The company is headquartered in Cambridge, Massachusetts, and its shares are listed on the NASDAQ.
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