AGIO Q2 Earnings Beat Estimates, Revenues Increase Year Over Year

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 2026, following the implementation of its Risk Evaluation and Mitigation Strategy program. Agios reported a strong initial uptake, with 442 prescriptions written as of June 30, 2026.

Outside the United States, mitapivat continues to be marketed as Pyrukynd for PK deficiency and thalassemia indications. In May, Pyrukynd received approval for thalassemia in the European Union. Agios’ partner, Avanzanite Bioscience B.V., will commercialize and distribute Pyrukynd across the European Economic Area, the United Kingdom and Switzerland.

AGIO's Q2 Earnings in Detail

The top line entirely comprises product revenues from Pyrukynd and Aqvesme. Agios generated $40.9 million of product revenues in the United States, up 235.2% year over year, driven by strong early momentum of the U.S. commercial launch of Aqvesme for thalassemia.

The company added $3.8 million from ex-U.S. territories, driven by anticipated demand for Pyrukynd following its approval for thalassemia in Europe, as well as continued steady early demand across the Gulf Cooperation Council countries.

Research and development expenses increased by approximately 9.6% year over year to $100.8 million in the quarter. The increase was primarily driven by the $25.0 million upfront payment related to the licensing agreement with Oscotec for cevidoplenib.

Selling, general and administrative expenses totaled $51.5 million, up around 12.4% year over year, driven by higher spending associated with the commercial launch of Aqvesme.

As of June 30, 2026, cash, cash equivalents and marketable securities totaled $964.8 million compared with $1.0 billion as of March 31, 2026. Management expects its existing cash balance, together with anticipated product revenues, to be sufficient to support the potential launch of mitapivat in sickle cell disease (SCD) if approved and advance its clinical pipeline.

AGIO’s 2026 Guidance

For full-year 2026, Agios expects to generate $45 million to $50 million in U.S. sales from Pyrukynd for PK deficiency.The company reiterated that full-year operating expenses are expected to remain approximately flat compared with 2025, excluding the $25 million upfront payment related to the cevidoplenib in-licensing agreement recognized in the second quarter.

AGIO's Recent Pipeline Updates

Beyond the marketed indications, Agios is also developing mitapivat for sickle cell disease (SCD). Earlier this month, the FDA accepted its supplemental new drug application (sNDA) seeking approval for mitapivat in SCD. The sNDA was submitted under the FDA’s accelerated approval pathway in May. With the FDA granting a priority review to the sNDA, a decision from the regulatory body is expected on Nov. 1, 2026. If approved, mitapivat is likely to become the first oral PK activator to be approved for patients with SCD.

Agios had been 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. However, the company has discontinued the development of tebapivat across all indications following setbacks in the clinical programs.

In June, the company halted the candidate's development for LR-MDS after a phase II dose-finding study failed to demonstrate sufficient clinical benefit, despite showing biological activity and a favorable safety profile. Subsequently, in July, Agios also discontinued the SCD program after phase II data failed to demonstrate meaningful clinical differentiation from existing PK activators. These decisions marked the complete termination of the tebapivat development program.

Despite the earnings beat, shares of AGIO were down 6.4% on Thursday, likely due to investor concern about the loss of tebapivat as a pipeline asset, which narrowed the company's growth prospects and increased its reliance on mitapivat, with its upcoming FDA decision now serving as the key catalyst.

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Year to date, the stock has risen 20.4% compared with the industry’s 3.6% growth.

In early June, the company entered into an agreement with Oscotec, a South Korea-based biotech to in-license exclusive global rights to develop and commercialize cevidoplenib for immune thrombocytopenia (ITP).

Cevidoplenib is a next-generation, late-stage, highly selective oral spleen tyrosine kinase inhibitor being developed for the treatment of patients with ITP, a rare autoimmune disorder characterized by low platelet counts and an elevated risk of bleeding.

The agreement expands and diversifies Agios’ rare hematology portfolio by adding a potential treatment for ITP, with an estimated peak annual U.S. sales potential of up to $1 billion. Agios intends to advance cevidoplenib into a phase III study for ITP, with initiation expected in the first half of 2028. Per the agreement, Agios will fund all future development and commercialization costs associated with cevidoplenib.

AGIO’s Zacks Rank & Stocks to Consider

Agios currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy) and Neurocrine Biosciences NBIX, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 90 days, earnings per share estimates for Harmony Biosciences have decreased from $3.34 to $3.30 for 2026. Over the same period, estimates for earnings per share increased from $3.79 to $3.87 for 2027. HRMY shares have lost 4.2% year to date.

Harmony Biosciences missed on earnings in each of the trailing four quarters, delivering an average negative surprise of 25.16%.

Over the past 90 days, estimates for Liquidia’s 2026 earnings per share have increased to $3.02 from $1.50. Over the same period, EPS estimates for 2027 have risen to $5.31 from $2.91. LQDA shares have gained 151.7% year to date.

Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.

Over the past 90 days, estimates for Neurocrine Biosciences’ 2026 earnings per share have risen from $8.00 to $9.09. Over the same period, EPS estimates for 2027 have increased from $9.48 to $10.81. NBIX shares have gained 30.8% year to date.

Neurocrine Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 9.08%.

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