SEC Filings

Agios Posts $55.4 Million In Drug Sales — More Than Four Times A Year Earlier

The rare-disease drugmaker plans research staffing cuts exceeding 100 roles as its sickle cell application faces a longer FDA review.

Matteo Parrino Jonathan Ponciano

Matteo Parrino, Jonathan Ponciano

— 3 min read
Share
Agios Posts $55.4 Million In Drug Sales — More Than Four Times A Year Earlier

Agios Pharmaceuticals, which develops and sells medicines for rare diseases, posted $55.4 million in third-quarter mitapivat sales, more than four times the $12.9 million a year earlier, according to its Thursday earnings release accompanying an SEC filing. The U.S. launch of Aqvesme for thalassemia drove the growth, while the company's net loss narrowed to $65.0 million from $103.4 million.

Aqvesme Builds A Patient Base

Agios Chief Executive Officer Brian Goff described the quarter's product revenue as “outperforming our entire 2025 total in just three months.”

The company's oral medicine mitapivat sells under two brands: Pyrukynd for adults with pyruvate kinase deficiency, an inherited disorder that causes anemia, and Aqvesme for adults with alpha- or beta-thalassemia in the United States. Agios handles U.S. sales itself and uses distribution partners abroad, including Avanzanite Bioscience in Europe and NewBridge Pharmaceuticals in the Gulf Cooperation Council region.

U.S. mitapivat revenue was $48.7 million, up 20% from the second quarter and compared with $12.3 million a year earlier. Outside the U.S., revenue reached $6.6 million, up 74% from the prior quarter and compared with $0.6 million a year earlier. Agios attributed the overseas increase primarily to European early-access programs following the European Union's thalassemia approval in late May 2026.

Aqvesme launched in the U.S. in late January 2026. By September 30, physicians certified under its required safety program had submitted 619 completed prescription start forms cumulatively, including 177 during the quarter; another 48 forms were being processed. Agios said demand was expanding among patients who need transfusions and those who do not, with approximately 75% still taking the medicine after six months.

Research Cuts, Higher Launch Spending

Agios expects to reduce research and development staffing by more than 100 roles by year-end, leaving that workforce more than 35% below its 2025 level. Savings from the reductions are expected to begin in 2027.

Quarterly research spending fell to $73.5 million from $86.8 million a year earlier, primarily because spending declined on mitapivat and tebapivat process development and certain trials. Selling and administrative expenses moved the other way, reaching $56.5 million from $41.3 million as Agios supported Aqvesme's launch and prepared for a potential sickle cell launch. Cost of sales was $2.5 million.

The quarterly loss per share narrowed to $1.09 from $1.78. For the first nine months, product revenue totaled $120.876 million versus $34.061 million a year earlier, while the net loss narrowed to $264.859 million from $304.742 million.

Cash, cash equivalents and marketable securities stood at $907.0 million on September 30, compared with $1.2 billion on December 31, 2025. Agios expects those resources, anticipated sales and interest income to fund its commercial launches and pipeline work; management targets adjusted profitability in 2028. AGIO shares rose about 4% to $29.26 in Friday trading.

Sickle Cell Decision Moves To February

The FDA moved mitapivat's sickle cell target decision date from November 1, 2026, to February 1, 2027. The agency requested information to assess whether a required safety program was needed, then classified Agios' response as a major amendment to the approval application, extending review by three months. Labeling discussions, including a potential safety program, continue.

Agios said continued treatment in its late-stage sickle cell trial sustained hemoglobin improvements for up to 115 weeks. Exploratory analyses conducted after the trial suggested potential benefits for kidney function and changes in heart structure; those findings remain potential benefits, rather than established outcomes.

Early-stage results for AG-236 in healthy volunteers also support potential dosing every six months for polycythemia vera, the company said. Agios has 14 abstracts accepted for the American Society of Hematology meeting in New Orleans on December 12–15, 2026, including three oral presentations with new mitapivat data.

Agios says it is ready to launch mitapivat for sickle cell disease, but that expansion remains dependent on the FDA's decision.

Sources

Read more