AGIO · Agios Pharmaceuticals, Inc.
Press releases and events scraped from the company's investor relations website. Past events open our own call or event page when we host one; otherwise listings link to the original source.
Recent news
| Date | Headline |
|---|---|
| 2026-07-30 |
Agios Reports Second Quarter 2026 Financial Results and Provides Business Update
Mitapivat (PYRUKYND ® and AQVESME™) delivered worldwide net revenues of $44.7 million in the second quarter of 2026, compared to $12.5 million in the second quarter of 2025 Strong U.S. commercial launch of AQVESME in thalassemia, with 442 cumulative prescriptions written as of June 30, 2026 sNDA |
| 2026-07-21 |
Agios Provides Update on Phase 2 Trial of Tebapivat in Sickle Cell Disease
Hemoglobin response rates for tebapivat, a PK activator, were consistent with the class of medicine, but Phase 2 results did not establish a differentiated profile to support continued development in sickle cell disease Safety and tolerability of tebapivat were consistent with prior sickle cell |
| 2026-07-07 |
U.S. FDA Grants Priority Review to Agios’ sNDA for Mitapivat in Sickle Cell Disease
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 |
| 2026-06-29 |
Agios to Host Second Quarter 2026 Financial Results Conference Call and Webcast on July 30 at 8:00 a.m. ET
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 |
| 2026-06-13 |
Agios Showcases RISE UP Phase 3 Results at EHA 2026 Plenary Session Reinforcing Strong Anti-Hemolytic Profile of Mitapivat in Sickle Cell Disease
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 |
| 2026-06-01 |
Agios Enters Exclusive Global License Agreement with Oscotec to Develop and Commercialize Next-Generation SYK Inhibitor Cevidoplenib
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, |
| 2026-05-29 |
Agios Provides Update on Phase 2b Trial of Tebapivat in Lower-Risk Myelodysplastic Syndromes
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 |
| 2026-05-22 |
Agios’ PYRUKYND® (mitapivat) Approved in the European Union for Adults with Thalassemia
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 |
| 2026-05-12 |
Agios Submits sNDA to FDA for U.S. Accelerated Approval of Mitapivat in Sickle Cell Disease
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 |
| 2026-05-12 |
Agios to Present New Data at EHA 2026 Reinforcing the Significant Therapeutic Impact of Mitapivat Across Multiple Rare Hemolytic Anemias
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. |
| 2026-04-29 |
Agios Reports First Quarter 2026 Financial Results and Provides Business Update
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 |
| 2026-04-06 |
Agios to Host First Quarter 2026 Financial Results Conference Call and Webcast on April 29 at 8:00 a.m. ET
CAMBRIDGE, Mass., April 06, 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 |
| 2026-03-31 |
Agios Advances Mitapivat Toward Potential U.S. Accelerated Approval in Sickle Cell Disease Following Pre-sNDA Meeting with FDA
Company has already submitted proposed confirmatory trial for FDA review, as required under accelerated approval pathway Company plans to submit mitapivat sNDA in sickle cell disease in the coming months, and is actively working with FDA to achieve alignment on confirmatory trial required for |
Past events
Source: https://investor.agios.com/