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Agios Pharmaceuticals Incurs Narrower-Than-Expected Q4 Loss
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Key Takeaways
AGIO reported Q4 loss of $1.85 per share and $20M in revenues, topping estimates.
Pyrukynd U.S. sales rose 49% year over year, while Aqvesme had a strong launch in December 2025.
AGIO eyes FDA talks in Q1 2026 for mitapivat in SCD after mixed phase III RISE UP data.
Agios Pharmaceuticals (AGIO - Free Report) reported a loss of $1.85 per share in the fourth quarter of 2025, narrower than the Zacks Consensus Estimate of a loss of $1.97. In the year-ago quarter, the company had reported a loss of $1.74 per share.
Total revenues for the fourth quarter of 2025 came in at $20 million, beating the Zacks Consensus Estimate of $10 million.
The company’s lead drug, mitapivat, is marketed under two brand names — Pyrukynd and Aqvesme. Pyrukynd is approved for the treatment of hemolytic anemia in adult patients with pyruvate kinase (PK) deficiency. Aqvesme is approved to treat anemia in adults with alpha- or beta-thalassemia.
Aqvesme received approval in the United States in December 2025 and was launched last month following the implementation of its Risk Evaluation and Mitigation Strategy program. Agios stated that the launch is off to a strong start.
Outside the United States, mitapivat continues to be marketed as Pyrukynd for both PK deficiency and thalassemia indications. In 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion recommending the marketing authorization application seeking label expansion for Pyrukynd in the thalassemia indication.
Over the past year, the stock has lost 15.7% against the industry’s increase of 17.9%.
Image Source: Zacks Investment Research
AGIO's Q4 Earnings in Detail
The top line comprises product revenues from Agios’ first marketed drug, Pyrukynd (mitapivat). The company did not mention any sales numbers for Aqvesme.
Agios generated $16 million of product revenues from Pyrukynd in the United States, up 49% year over year and 24% sequentially, driven by strong execution, an additional ordering week in the quarter and favorable gross-to-net adjustments.
In the ex-U.S. market, Agios recorded $4 million from Pyrukynd, which primarily reflected inventory stocking ahead as the market transitioned from a global managed access program (where the product was supplied free) to commercial supply. The company expects a sequential decline in ex-U.S. revenues in the first quarter of 2026.
Research & development expenses increased by approximately 6.4% year over year to $88.1 million in the fourth quarter due to higher costs related to pipeline development.
Selling, general and administrative expenses totaled $51.6 million in the fourth quarter of 2025, roughly flat compared with the year-ago quarter.
As of Dec. 30, 2025, cash, cash equivalents and marketable securities totaled $1.2 billion compared with $1.3 billion as of Sept. 30, 2025.
AGIO’s Full-Year 2025 Results
For 2025, AGIO reported total revenues of $54 million, which rose 48% year over year.
For full-year 2025, the company recorded a net loss of $7.12 per share against net earnings of $11.64 per share reported in 2024.
AGIO's Recent Pipeline Updates
Agios Pharmaceuticals is also developing mitapivat for sickle cell disease (“SCD”).
AGIO reported top-line data from the phase III RISE UP study of mitapivat for the treatment of SCD in November. The study met the primary endpoint of hemoglobin response and demonstrated a reduction in the annualized rate of sickle cell pain crises compared to placebo but failed to achieve statistical significance. The study also met key secondary endpoints of significant improvements in hemoglobin concentration and levels of indirect bilirubin from baseline.
The company intends to engage with the FDA in the first quarter of 2026 before filing for approval. The U.S. marketing application is expected to be filed after the FDA discussion.
Agios is developing another candidate, tebapivat, a novel PK activator, for the treatment of SCD in a mid-stage study. The company has completed patient enrollment and expects to report top-line results in the second half of 2026.
Over the past 60 days, estimates for Exelixis’2026 earnings per share have risen from $3.18 to $3.39. EXEL shares have surged 23.8% over the past year.
Exelixis’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 24.95%.
Over the past 60 days, estimates for Alkermes’ 2026 earnings per share have increased from $1.54 to $1.91. ALKS shares have lost 7.5% over the past year.
Alkermes’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average earnings surprise being 4.58%.
Over the past 60 days, estimates for Castle Biosciences’ 2026 loss per share have narrowed from $1.06 to 96 cents. CSTL shares have risen 15.8% over the past year.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 66.11%.
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Agios Pharmaceuticals Incurs Narrower-Than-Expected Q4 Loss
Key Takeaways
Agios Pharmaceuticals (AGIO - Free Report) reported a loss of $1.85 per share in the fourth quarter of 2025, narrower than the Zacks Consensus Estimate of a loss of $1.97. In the year-ago quarter, the company had reported a loss of $1.74 per share.
Total revenues for the fourth quarter of 2025 came in at $20 million, beating the Zacks Consensus Estimate of $10 million.
The company’s lead drug, mitapivat, is marketed under two brand names — Pyrukynd and Aqvesme. Pyrukynd is approved for the treatment of hemolytic anemia in adult patients with pyruvate kinase (PK) deficiency. Aqvesme is approved to treat anemia in adults with alpha- or beta-thalassemia.
Aqvesme received approval in the United States in December 2025 and was launched last month following the implementation of its Risk Evaluation and Mitigation Strategy program. Agios stated that the launch is off to a strong start.
Outside the United States, mitapivat continues to be marketed as Pyrukynd for both PK deficiency and thalassemia indications. In 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion recommending the marketing authorization application seeking label expansion for Pyrukynd in the thalassemia indication.
Over the past year, the stock has lost 15.7% against the industry’s increase of 17.9%.
Image Source: Zacks Investment Research
AGIO's Q4 Earnings in Detail
The top line comprises product revenues from Agios’ first marketed drug, Pyrukynd (mitapivat). The company did not mention any sales numbers for Aqvesme.
Agios generated $16 million of product revenues from Pyrukynd in the United States, up 49% year over year and 24% sequentially, driven by strong execution, an additional ordering week in the quarter and favorable gross-to-net adjustments.
In the ex-U.S. market, Agios recorded $4 million from Pyrukynd, which primarily reflected inventory stocking ahead as the market transitioned from a global managed access program (where the product was supplied free) to commercial supply. The company expects a sequential decline in ex-U.S. revenues in the first quarter of 2026.
Research & development expenses increased by approximately 6.4% year over year to $88.1 million in the fourth quarter due to higher costs related to pipeline development.
Selling, general and administrative expenses totaled $51.6 million in the fourth quarter of 2025, roughly flat compared with the year-ago quarter.
As of Dec. 30, 2025, cash, cash equivalents and marketable securities totaled $1.2 billion compared with $1.3 billion as of Sept. 30, 2025.
AGIO’s Full-Year 2025 Results
For 2025, AGIO reported total revenues of $54 million, which rose 48% year over year.
For full-year 2025, the company recorded a net loss of $7.12 per share against net earnings of $11.64 per share reported in 2024.
AGIO's Recent Pipeline Updates
Agios Pharmaceuticals is also developing mitapivat for sickle cell disease (“SCD”).
AGIO reported top-line data from the phase III RISE UP study of mitapivat for the treatment of SCD in November. The study met the primary endpoint of hemoglobin response and demonstrated a reduction in the annualized rate of sickle cell pain crises compared to placebo but failed to achieve statistical significance. The study also met key secondary endpoints of significant improvements in hemoglobin concentration and levels of indirect bilirubin from baseline.
The company intends to engage with the FDA in the first quarter of 2026 before filing for approval. The U.S. marketing application is expected to be filed after the FDA discussion.
Agios is developing another candidate, tebapivat, a novel PK activator, for the treatment of SCD in a mid-stage study. The company has completed patient enrollment and expects to report top-line results in the second half of 2026.
AGIO’s Zacks Rank & Stocks to Consider
AGIO currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Exelixis (EXEL - Free Report) , Alkermes (ALKS - Free Report) and Castle Biosciences (CSTL - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Exelixis’2026 earnings per share have risen from $3.18 to $3.39. EXEL shares have surged 23.8% over the past year.
Exelixis’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 24.95%.
Over the past 60 days, estimates for Alkermes’ 2026 earnings per share have increased from $1.54 to $1.91. ALKS shares have lost 7.5% over the past year.
Alkermes’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average earnings surprise being 4.58%.
Over the past 60 days, estimates for Castle Biosciences’ 2026 loss per share have narrowed from $1.06 to 96 cents. CSTL shares have risen 15.8% over the past year.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 66.11%.