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Agios Pharmaceuticals reported that the U.S. Food and Drug Administration has extended the Prescription Drug User Fee Act (PDUFA) goal date for the supplemental New Drug Application for mitapivat in sickle cell disease.
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Agios Pharmaceuticals (NASDAQ:AGIO) reported third-quarter financial results on Thursday. The transcript from the company’s third-quarter earnings call has been provided below.This transcript is brought to you by
Agios Pharmaceuticals reported third-quarter 2026 revenue of $55.4 million and announced a significant reduction in R&D headcount as part of a strategic operating model review.
Filed: 2026-11-05 AccNo: 0001439222-26-000129 Size: 325 KB Item 2.02: Results of Operations and Financial Condition Item 9.01: Financial Statements and Exhibits
Agios Pharmaceuticals announced that it will present new clinical data from its rare hematology portfolio at the 68th American Society of Hematology (ASH) Annual Meeting and Exposition in December 2026.
Over 45 pharmaceutical companies are advancing 50+ pipeline drugs for sickle cell disease treatment. Key developments include Agios Pharmaceuticals' mitapivat receiving FDA Priority Review, Novo Nordisk's etavopivat meeting Phase III endpoints, and CorrectSequence Therapeutics' CS-206 showing sustained vaso-occlusive crisis-free results. The pipeline features diverse mechanisms including PK activators, gene therapies, and fetal hemoglobin stimulants, with approximately 5+ drugs in late-stage development.