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AGIO's Q3 Loss Narrower Than Expected, Pyrukynd Drives Y/Y Revenues
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Key Takeaways
Agios reported a Q3 loss of $1.78 per share, beating expectations of a loss of $1.93.
AGIO's total revenues climbed 44% year over year to $12.9 million, fueled by Pyrukynd sales.
The FDA decision on Pyrukynd's thalassemia indication is due on Dec. 7, as the EMA gives a positive opinion.
Agios Pharmaceuticals (AGIO - Free Report) incurred a loss of $1.78 per share in the third quarter of 2025, narrower than the Zacks Consensus Estimate of a loss of $1.93. In the year-ago quarter, the company had reported earnings of $16.22 per share, which included a gain on the sale of contingent payments and a milestone payment from gain on the sale of the oncology business.
Agios reported total revenues of $12.9 million for the third quarter, which beat the Zacks Consensus Estimate of $10 million. Revenues rose 44% year over year.
Shares of Agios were up 2.9% yesterday owing to the better-than-expected results.
The stock has rallied 31.5% so far this year compared with the industry’s increase of 10.6%.
Image Source: Zacks Investment Research
AGIO's Q3 Earnings in Detail
In the reported quarter, revenues were generated entirely from product revenues of Agios’ only marketed drug, Pyrukynd (mitapivat), which is approved for treating hemolytic anemia in adults with pyruvate kinase (PK) deficiency in the United States and the EU.
The drug’s sales rose 3% sequentially. Per Agios, a total of 149 patients are on Pyrukynd therapy in the United States, up 5% from second-quarter 2025 levels.
Research & development expenses increased by approximately 19.7% year over year to $86.8 million due to higher costs related to studies on the PK activation franchise.
Selling, general and administrative expenses increased 7.3% year over year to $41.3 million. The increase was due to the company’s commercial preparations for a potential approval and subsequent launch of Pyrukynd in the thalassemia indication.
As of Sept. 30, 2025, cash, cash equivalents and marketable securities totaled $1.3 billion compared with $1.3 billion as of June 30, 2025.
AGIO's Recent Pipeline Updates
Agios’ lead PK activator, Pyrukynd, is the first disease-modifying therapy approved to treat adults with PK deficiency, a rare and debilitating blood disorder.
Besides PK deficiency, Pyrukynd is also being developed for other hemolytic anemias, including sickle cell disease (SCD) and thalassemia, in several label expansion studies.
In September, the FDA extended the review timeline for the supplemental new drug application (sNDA) seeking label expansion for Pyrukynd in the thalassemia indication by an additional three months. A final decision from the regulatory body is now expected on Dec. 7, 2025.
The extension was due to the FDA’s request for a Risk Evaluation and Mitigation Strategy (REMS) to address the potential risk of hepatocellular (liver) injury mentioned in the original sNDA for Pyrukynd. The extension was not related to any new efficacy or safety data.
Earlier this month, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the marketing authorization application seeking label expansion for Pyrukynd in the thalassemia indication. A final decision from the European Commission is expected in early 2026.
Pyrukynd secured its first approval in the thalassemia indication in Saudi Arabia in August 2025.
AGIO completed enrollment in the phase III RISE UP study of mitapivat for treating SCD last October. Top-line data from the study is expected by the end of 2025. A regulatory filing and a potential approval and launch in the United States are expected in 2026.
Agios is developing tebapivat, a novel PK activator, for the treatment of myelodysplastic syndromes, a rare type of blood cancer.
The company has completed patient enrollment in the phase IIb study on tebapivat for treating lower-risk myelodysplastic syndromes. Top-line data from the same is expected in early 2026.
Agios Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
In the past 60 days, estimates for ANI Pharmaceuticals’ earnings per share have increased from $7.25 to $7.29 for 2025. During the same time, earnings per share estimates for 2026 have increased from $7.74 to $7.81. Year to date, shares of ANIP have surged 66.3%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, the average surprise being 22.66%.
In the past 60 days, estimates for Beam Therapeutics' loss per share have narrowed from $4.36 to $4.23 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $4.41 to $4.21. Year to date, shares of BEAM have lost 4.1%.
Beam Therapeutics’ earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average negative surprise being 2.62%.
In the past 60 days, estimates for Intellia’s loss per share have narrowed from $4.15 to $4.14 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $4.12 to $4.10. Year to date, shares of NTLA have gained 5.2%.
Intellia’s earnings beat estimates in each of the trailing four quarters, the average surprise being 6.21%.
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AGIO's Q3 Loss Narrower Than Expected, Pyrukynd Drives Y/Y Revenues
Key Takeaways
Agios Pharmaceuticals (AGIO - Free Report) incurred a loss of $1.78 per share in the third quarter of 2025, narrower than the Zacks Consensus Estimate of a loss of $1.93. In the year-ago quarter, the company had reported earnings of $16.22 per share, which included a gain on the sale of contingent payments and a milestone payment from gain on the sale of the oncology business.
Agios reported total revenues of $12.9 million for the third quarter, which beat the Zacks Consensus Estimate of $10 million. Revenues rose 44% year over year.
Shares of Agios were up 2.9% yesterday owing to the better-than-expected results.
The stock has rallied 31.5% so far this year compared with the industry’s increase of 10.6%.
Image Source: Zacks Investment Research
AGIO's Q3 Earnings in Detail
In the reported quarter, revenues were generated entirely from product revenues of Agios’ only marketed drug, Pyrukynd (mitapivat), which is approved for treating hemolytic anemia in adults with pyruvate kinase (PK) deficiency in the United States and the EU.
The drug’s sales rose 3% sequentially. Per Agios, a total of 149 patients are on Pyrukynd therapy in the United States, up 5% from second-quarter 2025 levels.
Research & development expenses increased by approximately 19.7% year over year to $86.8 million due to higher costs related to studies on the PK activation franchise.
Selling, general and administrative expenses increased 7.3% year over year to $41.3 million. The increase was due to the company’s commercial preparations for a potential approval and subsequent launch of Pyrukynd in the thalassemia indication.
As of Sept. 30, 2025, cash, cash equivalents and marketable securities totaled $1.3 billion compared with $1.3 billion as of June 30, 2025.
AGIO's Recent Pipeline Updates
Agios’ lead PK activator, Pyrukynd, is the first disease-modifying therapy approved to treat adults with PK deficiency, a rare and debilitating blood disorder.
Besides PK deficiency, Pyrukynd is also being developed for other hemolytic anemias, including sickle cell disease (SCD) and thalassemia, in several label expansion studies.
In September, the FDA extended the review timeline for the supplemental new drug application (sNDA) seeking label expansion for Pyrukynd in the thalassemia indication by an additional three months. A final decision from the regulatory body is now expected on Dec. 7, 2025.
The extension was due to the FDA’s request for a Risk Evaluation and Mitigation Strategy (REMS) to address the potential risk of hepatocellular (liver) injury mentioned in the original sNDA for Pyrukynd. The extension was not related to any new efficacy or safety data.
Earlier this month, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the marketing authorization application seeking label expansion for Pyrukynd in the thalassemia indication. A final decision from the European Commission is expected in early 2026.
Pyrukynd secured its first approval in the thalassemia indication in Saudi Arabia in August 2025.
AGIO completed enrollment in the phase III RISE UP study of mitapivat for treating SCD last October. Top-line data from the study is expected by the end of 2025. A regulatory filing and a potential approval and launch in the United States are expected in 2026.
Agios is developing tebapivat, a novel PK activator, for the treatment of myelodysplastic syndromes, a rare type of blood cancer.
The company has completed patient enrollment in the phase IIb study on tebapivat for treating lower-risk myelodysplastic syndromes. Top-line data from the same is expected in early 2026.
Agios Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Agios Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Agios Pharmaceuticals, Inc. Quote
AGIO's Zacks Rank & Stocks to Consider
Agios currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals (ANIP - Free Report) , Beam Therapeutics (BEAM - Free Report) and Intellia Therapeutics (NTLA - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ earnings per share have increased from $7.25 to $7.29 for 2025. During the same time, earnings per share estimates for 2026 have increased from $7.74 to $7.81. Year to date, shares of ANIP have surged 66.3%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, the average surprise being 22.66%.
In the past 60 days, estimates for Beam Therapeutics' loss per share have narrowed from $4.36 to $4.23 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $4.41 to $4.21. Year to date, shares of BEAM have lost 4.1%.
Beam Therapeutics’ earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average negative surprise being 2.62%.
In the past 60 days, estimates for Intellia’s loss per share have narrowed from $4.15 to $4.14 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $4.12 to $4.10. Year to date, shares of NTLA have gained 5.2%.
Intellia’s earnings beat estimates in each of the trailing four quarters, the average surprise being 6.21%.