Agios Pharmaceuticals, Inc. Stock News

Agios Pharmaceuticals, Inc. (AGIO) Discusses FDA Approval of AQVESME for Anemia in Alpha and Beta Thalassemia Transcript

Agios Pharmaceuticals upgraded to buy (market perform) after FDA approval of Aqvesme for Alpha- or Beta-Thalassemia, despite boxed warning for liver injury. AGIO's commercial upside from thalassemia is capped, with peak sales estimates around $500M, insufficient alone for profitability; SCD approval remains a major potential catalyst. AGIO maintains a strong cash position of $1.3B versus $101M ...

The new indication is relatively rare in the U.S., but pricing is substantial, and the need for the treatment is significant. The positive update turns the company's fortunes around after a disappointing update earlier in the year.

Shares of Agios Pharmaceuticals surged nearly 15% in premarket trading on Wednesday after the US Food and Drug Administration approved an expanded use of its drug mitapivat, strengthening investor optimism around the company's growth prospects.

Shares of Agios Pharmaceuticals jumped nearly 12% premarket on Wednesday after the U.S. Food and Drug Administration approved the expanded use of its drug for the treatment of a type of blood disorder.

AQVESME is the only FDA-approved medicine for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia Marketed under AQVESME brand name in the U.S. for thalassemia indication; PYRUKYND® (mitapivat) remains the U.S. brand name for PK deficiency indication  AQVESME expected to be available in late January 2026, following AQVESME REMS program implementation Co...

Agios today announced that the U.S. Food and Drug Administration (FDA) has not yet issued a regulatory decision on the sNDA for mitapivat in thalassemia

Agios Pharmaceuticals, Inc. ( AGIO ) Discusses Topline Results from RISE UP Phase 3 Trial of Mitapivat in Sickle Cell Disease November 19, 2025 8:00 AM EST Company Participants Morgan Sanford Brian Goff - CEO & Director Sarah Gheuens - Chief Medical Officer and Head of Research & Development Tsveta Milanova - Chief Commercial Officer Conference Call Participants Biree Andemariam Eric Schmidt - ...