Agios Pharmaceuticals Announces 2026 Strategic Priorities Including AQVESME™ U.S. Thalassemia Launch, Planned Regulatory Submission for Sickle Cell Disease, and Advancement of Rare Disease Pipeline Toward Projected $1 Billion Peak Sales

Reuters01-12
Agios Pharmaceuticals Announces 2026 Strategic Priorities Including AQVESME™ U.S. Thalassemia Launch, Planned Regulatory Submission for Sickle Cell Disease, and Advancement of Rare Disease Pipeline Toward Projected $1 Billion Peak Sales

Agios Pharmaceuticals Inc. has outlined its 2026 strategic priorities and key milestones, focusing on expanding its rare disease portfolio. The company plans to continue the U.S. commercial launch of AQVESME™ (mitapivat) for thalassemia following recent FDA approval and anticipates a pre-sNDA meeting with the FDA for mitapivat in sickle cell disease in the first quarter of 2026, with a regulatory submission to follow. Agios is also advancing its early- and mid-stage pipeline across multiple indications, including reporting topline results from the Phase 2b LR-MDS trial of tebapivat and a Phase 1 healthy volunteer trial of AG-236 for polycythemia vera in the first half of 2026. Additionally, the company expects to initiate a Phase 1b proof-of-mechanism trial of AG-181 in patients with phenylketonuria and confirm proof of mechanism in the second half of the year. Agios projects a clear path to profitability through its commercial presence in thalassemia and PK deficiency, with the potential to achieve over $1 billion in peak global sales.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Agios Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 9623501) on January 12, 2026, and is solely responsible for the information contained therein.

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