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AGIO Stock Falls as FDA Delays Decision on Pyrukynd for Thalassemia
ZACKSยท 2025-09-05 15:05
Key Takeaways AGIO stock dropped 11% as the FDA extended Pyrukynd's thalassemia review by three months.The delay follows Agios' proposed REMS to address liver injury risks flagged in original filings.A decision is now expected on Dec. 7, 2025, instead of the original September target date.Shares of Agios Pharmaceuticals (AGIO) fell 11% on Thursday after the company announced that the FDA had extended the review timeline for the supplemental new drug application (sNDA) seeking label expansion for its sole ma ...