Agios Pharmaceuticals, Inc.
0 products tracked · names used in filings: Agios Pharmaceuticals, Inc.
Upcoming milestones
mitapivat: PDUFA target action date (sickle cell disease)
Agios Pharmaceuticals, Inc. (AGIO); mitapivat; sNDA; status: extended; "…New PDUFA goal date for mitapivat sickle cell disease sNDA set for February 1, 2027; company is launch-ready and in labeling discussions with FDA • 14 abstracts accepted at ASH 2026, including new clinic"; filed 2026-11-05 · source
Recent milestones
PYRUKYND: PDUFA target action date (non–transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia)
Agios Pharmaceuticals, Inc. (AGIO); mitapivat; sNDA; status: extended; "…PDUFA goal date for PYRUKYND U.S. sNDA in thalassemia set for December 7, 2025 • CHMP adopted positive opinion for PYRUKYND in thalassemia; EC decision expected by early 2026 • RISE UP Phase 3 trial topline results in sickle cell disease by year-end; potential U.S."; filed 2025-10-30 · source
Products
No products recorded.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.