Agios Pharmaceuticals AGIO reported a loss of $1.69 per share for the first quarter of 2026, narrower than the Zacks Consensus Estimate of a loss of $1.81. In the year-ago quarter, the company had incurred a loss of $1.55 per share.
Total revenues for the first quarter of 2026 came in at $20.7 million, beating the Zacks Consensus Estimate of $13.8 million. Revenues surged 138% year over year, primarily driven by the U.S. commercial launch of Aqvesme and continued strong growth in Pyrukynd sales.
The company’s lead drug, mitapivat, is marketed under two brand names in the United States — Pyrukynd and Aqvesme. While 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 subsequently launched in January following the implementation of its Risk Evaluation and Mitigation Strategy program. Agios reported a strong initial uptake, with 242 prescriptions written as of March 2026.
Shares of AGIO rose 13% on Wednesday, likely due to the better-than-expected sales performance of its marketed products. Year to date, the stock has risen 3.1% against the industry’s 1.4% decline.
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Outside the United States, mitapivat continues to be marketed as Pyrukynd for both PK deficiency and thalassemia indications. In March 2026, Pyrukynd received approval for thalassemia in the United Arab Emirates. Meanwhile, a marketing authorization application seeking label expansion for Pyrukynd in the thalassemia indication is currently under review in the EU.
AGIO's Q1 Earnings in Detail
The top line entirely comprises product revenues from Pyrukynd and Aqvesme. However, the company did not disclose separate sales figures for the two drugs.
Agios generated $18.8 million of product revenues from the sales of both drugs in the United States. The reported figure was up 116% year over year, driven by strong early momentum of the U.S. commercial launch of Aqvesme in thalassemia.
The company added $1.9 million from ex-U.S. territories, reflecting demand for Pyrukynd in the thalassemia indication across the Gulf Council Countries.
Research & development expenses increased by approximately 11.6% year over year to $81.1 million in the first quarter due to higher costs related to pipeline development.
Selling general and administrative expenses totaled $48.3 million, up 16.3% year over year, driven by higher stock compensation expense and expenses associated with the commercial launch of Aqvesme.
As of March 31, 2026, cash, cash equivalents and marketable securities totaled $1.0 billion compared with $1.2 billion as of Dec. 31, 2025.
AGIO's Recent Pipeline Updates
Agios is also developing mitapivat for sickle cell disease (SCD).
Following mixed data from the phase III RISE UP study reported in November 2025, the company recently announced its intention to seek accelerated approval for mitapivat for the treatment of SCD, after a pre-supplemental new drug application (sNDA) meeting with the FDA. Based on discussions at the meeting, the regulatory authority asked Agios to submit a proposal for a confirmatory clinical study to support this pathway.
The company is closely engaged with the FDA to align on the requirements for the confirmatory study needed to support accelerated approval and expects to file the sNDA for mitapivat in SCD in the second quarter of 2026.
Agios is developing another candidate, tebapivat, a novel PK activator, for the treatment of lower-risk myelodysplastic syndromes (LR-MDS) and SCD in separate mid-stage studies. The company expects to report top-line data from the phase IIb study for LR-MDS in the first half of 2026. Top-line data from the SCD study is expected in the second half of 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
AGIO currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Castle Biosciences (CSTL), currently sporting a Zacks Rank #1 (Strong Buy), and Indivior Pharmaceuticals INDV and Catalyst Pharmaceuticals CPRX, which carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Castle Biosciences’ 2026 loss per share have narrowed from $1.42 to $1.40. Over the same period, loss per share estimates for 2027 have also narrowed from 79 cents to 78 cents. CSTL shares have lost 37.6% year to date.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 34.69%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have decreased from $3.01 to $3.00. Over the same period, EPS estimates for 2027 have plunged from $3.35 to $3.29. INDV shares have lost 4.8% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 74.53%.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.82 to $2.87. Over the same period, EPS estimates for 2027 have surged from $3.20 to $3.25. CPRX shares have gained 21.1% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
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Catalyst Pharmaceuticals, Inc. (CPRX): Free Stock Analysis Report
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This article originally published on Zacks Investment Research (zacks.com).