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.

fool.com - 2026-07-10 07:35:00

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.

zacks.com - 2026-07-08 11:36:15

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.

zacks.com - 2026-07-08 11:30:14

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.

fool.com - 2026-07-07 12:32:49

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

investors.com - 2026-07-07 11:30:02

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.

globenewswire.com - 2026-07-07 07:00:00

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.

globenewswire.com - 2026-06-29 07:00:00

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.

zacks.com - 2026-06-18 12:25:15

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.

marketbeat.com - 2026-06-13 14:07:19

Agios Pharmaceuticals, Inc. (AGIO) Discusses New Data and Strategic Expansion in Rare Hematology at EHA Investor Event Transcript

seekingalpha.com - 2026-06-13 14:02:09

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.

globenewswire.com - 2026-06-13 09:00:00

Agios gains global rights to cevidoplenib for ITP, adding a late-stage rare hematology asset with up to $1B U.S. peak sales potential.

zacks.com - 2026-06-02 11:25:17

Agios Pharmaceuticals, Inc. (AGIO) Discusses Global License Agreement for Cevidoplenib and Strategic Expansion in Rare Hematology Transcript

seekingalpha.com - 2026-06-01 16:24:07

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).

proactiveinvestors.com - 2026-06-01 12:28:17

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.

zacks.com - 2026-06-01 10:46:40

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.

globenewswire.com - 2026-06-01 05:00:00

Agios Pharmaceuticals (AGIO) reported earnings 30 days ago. What's next for the stock?

zacks.com - 2026-05-29 12:32:12

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.

reuters.com - 2026-05-29 07:21:16

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).

globenewswire.com - 2026-05-29 07:00:00

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.

zacks.com - 2026-05-25 12:11:06

AMSTERDAM--(BUSINESS WIRE)-- #Avanzanite--Avanzanite Bioscience B.V., a rapidly growing commercial-stage European specialty pharmaceutical company focused on rare diseases, today reported that its partner, Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company headquartered in Cambridge, Massachusetts focused on delivering innovative medicines for patients with rare diseases, announced that the European Commission has granted marketing authorisation for PYRUKYND® (mitapivat).

businesswire.com - 2026-05-22 10:18:00

PYRUKYND is the only medicine approved in the EU for adults with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassemia Mitapivat is now approved for thalassemia in the U.S., Saudi Arabia, United Arab Emirates, and EU Avanzanite Bioscience B.V., a specialty pharmaceutical company, will continue to distribute and commercialize PYRUKYND in Europe CAMBRIDGE, Mass.

globenewswire.com - 2026-05-22 09:15:00

Agios Pharmaceuticals NASDAQ: AGIO executives said the company is focused on advancing mitapivat across rare hematologic diseases, highlighting early launch traction in thalassemia and a recently submitted supplemental new drug application for sickle cell disease during a presentation at the 2026 RBC Capital Markets Global Healthcare Conference.

marketbeat.com - 2026-05-19 13:04:49

AGIO seeks FDA accelerated approval for mitapivat in sickle cell disease after mixed phase III data and a planned confirmatory study.

zacks.com - 2026-05-13 12:25:37

sNDA submission follows agreement with FDA on confirmatory trial, a requirement of the accelerated approval pathway Confirmatory trial designed to demonstrate clinical benefit of mitapivat on reducing transfusion burden in sickle cell disease CAMBRIDGE, Mass. , May 12, 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 submission of its supplemental New Drug Application (sNDA) to the U.

globenewswire.com - 2026-05-12 09:31:00

sNDA submission follows agreement with FDA on confirmatory trial, a requirement of the accelerated approval pathway Confirmatory trial designed to demonstrate clinical benefit of mitapivat on reducing transfusion burden in sickle cell disease CAMBRIDGE, Mass., May 12, 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 submission of its supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the U.S. accelerated approval of mitapivat, an oral pyruvate kinase (PK) activator, in sickle cell disease.

globenewswire.com - 2026-05-12 09:31:00

Detailed results from RISE UP Phase 3 trial of mitapivat in sickle cell disease selected for distinguished Plenary Abstracts Session Company to host investor conference call and webcast during EHA 2026 on Saturday, June 13, at 9:00 a.m. ET (3:00 p.m.

globenewswire.com - 2026-05-12 09:30:00

The company faces competitive pressure from Novo Nordisk, but it's growing sales from its existing approved drugs and has an exciting drug in its pipeline.

fool.com - 2026-05-02 07:55:00

Agios shares jump 13% as Q1 revenues surge 138% on Aqvesme launch and Pyrukynd growth, while pipeline advances and SCD filing plans take shape.

zacks.com - 2026-04-30 15:35:15

There's power in the company's No. 1 molecule.

fool.com - 2026-04-29 18:27:14

Agios Pharmaceuticals, Inc. (AGIO) Q1 2026 Earnings Call Transcript

seekingalpha.com - 2026-04-29 15:01:49

Agios Pharmaceuticals (AGIO) came out with a quarterly loss of $1.69 per share versus the Zacks Consensus Estimate of a loss of $1.81. This compares to a loss of $1.55 per share a year ago.

zacks.com - 2026-04-29 08:46:33

Mitapivat (PYRUKYND® and AQVESME™) generated worldwide net revenues of $20.7 million in the first quarter of 2026, compared to $8.7 million in the first quarter of 2025 Strong initial U.S. commercial launch of AQVESME in thalassemia, with 242 prescriptions written as of March 31, 2026 Company plans to submit mitapivat sNDA for sickle cell disease in the second quarter of 2026 Pipeline advancing to multiple value-driving inflection points in 2026, including two Phase 2 readouts for next-generation PK activator tebapivat $1.0 billion in cash, cash equivalents, and marketable securities as of March 31, 2026 CAMBRIDGE, Mass., April 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 financial results and updates for the first quarter ended March 31, 2026.

globenewswire.com - 2026-04-29 06:30:00

A rival company's trial results had a negative impact on Agios' stock this week.

fool.com - 2026-04-24 05:36:24

Agios Pharmaceuticals (AGIO) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

zacks.com - 2026-04-22 11:01:52

AGIO shares plunge after Novo Nordisk's strong sickle cell data raised doubts about mitapivat's competitiveness and approval prospects.

zacks.com - 2026-04-21 10:36:10

The market is concerned about the diminished market potential for Agios' mitapavit following today's newsflow.

fool.com - 2026-04-20 12:19:21