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AGIO · Analysis updated Nov 10, 2026, 6:00 PM ET
Why is Agios Pharmaceuticals, Inc. (AGIO) stock moving?
Agios reported Q3 2026 revenue of $55.4M, more than four times the $12.9M of Q3 2025 and above the $53.2M consensus, with EPS of -$1.09 against -$1.20 expected. U.S. AQVESME (mitapivat) demand in thalassemia is growing, with 619 cumulative prescriptions with completed start forms, and ex-U.S. revenue rose 74% sequentially. The company holds $907.0M in cash and targets non-GAAP profitability in 2028. The stock's main overhang is the FDA's extension of the mitapivat sickle cell PDUFA date by about three months to February 1, 2027, which drove a roughly 18% drop on Oct 30 on 3.1M shares, about three times the typical volume. The company also announced a significant R&D headcount reduction, and BofA and Truist trimmed price targets to $48 and $35 while keeping their ratings, with Truist maintaining Buy. HC Wainwright remains Buy and raised its target to $62. The stock fell to a $27.57 low on Nov 5 but has since recovered to $31.76 on Nov 10, with the last two sessions on above-average volume. The sickle cell decision is still ahead, so the outlook depends on that regulatory outcome as well as on commercial execution.
News behind the analysis
- BofA Securities Adjusts Agios Pharmaceuticals Price Target to $48 From $50BofA Securities lowered its price target on Agios from $50 to $48.
- Truist Securities Maintains Buy Rating on Agios Pharmaceuticals, Lowers Price Target to $35Truist reaffirmed its Buy rating but cut its price target from $37 to $35.
- HC Wainwright & Co. Maintains Buy on Agios Pharmaceuticals, Raises Price Target to $62HC Wainwright kept its Buy rating and raised its price target to $62.
- Agios Reports Third Quarter 2026 Financial Results and Provides Business UpdateQ3 2026 worldwide net revenue was $55.4M, more than four times Q3 2025, with $907.0M in cash and a target of non-GAAP profitability in 2028. The company also announced a significant R&D headcount reduction.
- Agios Pharmaceuticals Q3 EPS $(1.09) Beats $(1.20) Estimate, Sales $55.385M Beat $53.208M EstimateAgios beat both consensus EPS (-$1.09 vs -$1.20) and revenue ($55.4M vs $53.2M) for Q3.
- Agios Pharmaceuticals to Present New Clinical Data at ASH 2026Agios will present new rare hematology data at the ASH 2026 annual meeting in December, including mitapivat in sickle cell disease and AG-236 in polycythemia vera.
- Agios Pharmaceuticals Announces FDA Extension of PDUFA Goal Date for Mitapivat in Sickle Cell DiseaseThe FDA extended the PDUFA goal date for the mitapivat sickle cell disease sNDA to February 1, 2027; the company says it is launch-ready and in labeling discussions with the FDA.
- Agios Pharmaceuticals Says FDA Extends Mitapivat PDUFA Date For Sickle Cell Disease To February 1, 2027Benzinga reports the FDA has extended the mitapivat sickle cell PDUFA date to February 1, 2027.
- HC Wainwright & Co. Assumes Agios Pharmaceuticals at Buy, Announces Price Target of $55HC Wainwright initiated coverage of Agios with a Buy rating and a $55 price target.
About Agios Pharmaceuticals, Inc.
Agios Pharmaceuticals is a commercial-stage biotech company based in Cambridge, Massachusetts. It focuses on rare blood disorders, and its main product is mitapivat, a pill that activates the enzyme pyruvate kinase. Mitapivat is sold as PYRUKEND for pyruvate kinase deficiency and as AQVESME for thalassemia, and the company is seeking FDA approval to use it in sickle cell disease too.
How it makes money
Almost all of its revenue comes from US sales of mitapivat. Sales have grown quickly since AQVESME launched for thalassemia, reaching roughly $45 million in net revenue in Q2 2026. The company still loses money and pays for its research mostly from a cash pile of about $0.9 billion, much of which came from selling its royalty rights on the cancer drug Tibsovo. Agios says it aims to be profitable on a non-GAAP basis in 2028.
What usually moves AGIO
- FDA decision on mitapivat for sickle cell disease (target date Feb 1, 2027)
- How fast AQVESME sales grow in thalassemia
- Clinical trial results and pipeline deals, such as the Oscotec license
- How quickly it spends cash and how close it gets to profitability
- Competition and takeover activity among rare blood-disease biotechs