AGIO - Agios Pharmaceuticals, Inc.
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.
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.
Agios Pharmaceuticals, Inc. (AGIO) Discusses New Data and Strategic Expansion in Rare Hematology at EHA Investor Event Transcript
Mitapivat demonstrated statistically significant improvement in hemoglobin response compared with placebo, with rapid onset and durable effects New analyses showed patients in mitapivat arm had clinically meaningful reduction in transfusion burden compared with placebo Patients in mitapivat arm who achieved hemoglobin response had clinically meaningful benefits across measures of sickle cell pain crises, fatigue, and other patient-reported outcomes Mitapivat was well-tolerated, with a safety profile consistent with previous trials of mitapivat in sickle cell disease Company to host investor conference call and webcast today at 9:00 a.m. ET (3:00 p.m.
Agios gains global rights to cevidoplenib for ITP, adding a late-stage rare hematology asset with up to $1B U.S. peak sales potential.
Agios Pharmaceuticals, Inc. (AGIO) Discusses Global License Agreement for Cevidoplenib and Strategic Expansion in Rare Hematology Transcript
Agios Pharmaceuticals (NASDAQ:AGIO) has secured exclusive global rights to cevidoplenib, a next-generation oral SYK inhibitor, under a licensing agreement with South Korea's Oscotec, the company said Monday. The agreement gives Agios worldwide rights to develop and commercialize cevidoplenib, which the company described as a novel, next-generation oral inhibitor of spleen tyrosine kinase (SYK).
Agios discontinues development of tebapivat in lower-risk MDS after a phase IIb study misses efficacy goals, shifting focus to a phase II SCD program.
Agios obtains exclusive global rights to novel, late-stage, next-generation, oral SYK inhibitor Agreement diversifies Agios' rare hematology portfolio with expansion into immune thrombocytopenia, unlocking up to $1 billion in peak U.S. sales potential Oscotec will receive $25.0 million upfront, with future payments tied to development, regulatory, and commercial milestones, as well as tiered royalties on future net sales Agios will host investor conference call and webcast today at 8:00 a.m. ET CAMBRIDGE, Mass.
Agios Pharmaceuticals (AGIO) reported earnings 30 days ago. What's next for the stock?
Agios Pharmaceuticals said on Friday it will stop developing its experimental drug for a form of blood cancer after a mid-stage trial failed to show enough benefit.
Results did not meet predefined threshold to support further development in LR-MDS Tebapivat was well tolerated, with no new safety signals observed CAMBRIDGE, Mass., May 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 that it will not advance tebapivat, a next-generation oral pyruvate kinase (PK) activator, in lower-risk myelodysplastic syndromes (LR-MDS).
Agios wins EU approval for Pyrukynd in adult thalassemia patients, expanding the drug's reach as the only authorized therapy for a broad patient population.