Agios Pharmaceuticals

AGIO

Market cap $2.38B

Agios stock surged after FDA granted priority review for mitapivat in sickle cell disease. Mitapivat showed mixed Phase 3 results, and competition is coming from Novo Nordisk.

Agios stock jumps after the FDA accepts and grants priority review to its sNDA for mitapivat in sickle cell disease, with a decision due on Nov. 1, 2026.

Agios Pharmaceuticals (AGIO) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.

The company took a major step toward an accelerated approval of mitapivat in sickle cell disease today. Agios needs to complete a confirmatory trial before a full traditional approval can be granted.

Agios stock skyrocketed closer to a profit-taking zone Tuesday after the FDA assigned its sickle cell drug a speedy review.

U.S. stocks were mixed, with the Nasdaq Composite falling around 1% on Tuesday.

FDA's PDUFA goal date is November 1, 2026 If approved, mitapivat is positioned to become the first oral PK activator for patients with sickle cell disease CAMBRIDGE, Mass., July 07, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for mitapivat, an oral pyruvate kinase (PK) activator, in sickle cell disease with a Priority Review.

CAMBRIDGE, Mass., June 29, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced the company will host a conference call and live webcast on Thursday, July 30, 2026, at 8:00 a.m.

Agios' shares rose 35% in six months as Aqvesme gains traction, mitapivat expands globally and new ITP rights add to its rare blood disease push.

Agios Pharmaceuticals NASDAQ: AGIO used an investor webcast tied to the 2026 European Hematology Association Congress in Stockholm to highlight new clinical data for mitapivat across thalassemia and sickle cell disease, while outlining a broader rare disease strategy that now includes multiple hematology and metabolic programs.