Agios Pharmaceuticals reports strong Q3 2026 results

Item 2.02 Results of Operations and Financial Condition.

On November 5, 2026, Agios Pharmaceuticals, Inc. issued a press release announcing its results for the quarter ended September 30, 2026 and other business highlights.¹ A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Form 8-K, including Exhibit 99.1, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No. Description

99.1 Press release issued November 5, 2026

104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

AGIOS PHARMACEUTICALS, INC.

Date: November 5, 2026

By:

/s/ Brian Goff

Brian Goff

Chief Executive Officer

Agios Reports Third Quarter 2026 Financial Results and Provides Business Update

• New PDUFA goal date for mitapivat sickle cell disease sNDA set for February 1, 2027; company is launch-ready and in labeling discussions with FDA⁸

CAMBRIDGE, Mass. , Nov. 5, 2026 – Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced financial results and updates for the third quarter ended September 30, 2026.

"The third quarter was a record for our product revenue, outperforming our entire 2025 total in just three months. This growth was driven by the U.S. commercial launch of AQVESME in thalassemia, where broadening demand is translating into a durable base of patients on therapy," said Brian Goff, Chief Executive Officer, Agios. "This launch has built the commercial foundation for our largest indication opportunity with mitapivat – sickle cell disease. Our conviction in mitapivat for patients with sickle cell disease is grounded in the robust efficacy and safety data generated to date and we are launch-ready ahead of our PDUFA goal date of February 1, 2027. With this commercial infrastructure, alongside a strong balance sheet and a disciplined operating model, Agios is well positioned for sustained growth as a focused, rare hematology company."

Third Quarter 2026 and Recent Corporate Highlights

• Mitapivat (PYRUKYND® and AQVESME®) Commercial Performance and Update – o $48.7 million in U.S. net revenue and $6.6 million in ex-U.S. net revenue in the third quarter of 2026

• U.S. net revenue increased 20% sequentially, driven by the U.S. commercial launch of AQVESME (mitapivat) in thalassemia in late January 2026.

• Ex-U.S. net revenue increased 74% sequentially, driven primarily by early access programs in Europe following the late May 2026 approval of PYRUKYND (mitapivat) in thalassemia in the European Union⁴. This robust, early momentum underscores the strong global opportunity for mitapivat, which the company is advancing through capital-efficient partnerships with Avanzanite Bioscience B.V. in Europe and NewBridge Pharmaceuticals in the Gulf Cooperation Council (GCC) region.

o AQVESME demand continues to expand following the January 2026 U.S. commercial launch in thalassemia

• In the third quarter, 177 AQVESME prescriptions with completed Agios start forms (ASFs) were written by Risk Evaluation and Mitigation Strategy (REMS)-certified U.S. physicians, bringing cumulative prescriptions to 619 as of September 30, 2026³.

• An additional 48 cumulative prescriptions had ASFs in process as of September 30, 2026, which are not included in the reported metric above.

• Demand continues to broaden, with deeper penetration in transfusion-dependent patients and expansion into the larger non-transfusion dependent population. Approximately 75% of patients remain on AQVESME after six months of treatment.

• Operating Model Update – o Over the course of 2026, Agios reviewed its operating model, and will have reduced its R&D headcount by over 100 roles by year-end, representing a more than 35% decrease compared with 2025. The company expects the associated cost savings of these reductions to be realized in 2027.

Research and Development (R&D) Highlights

• Mitapivat (pyruvate kinase [PK] activator) – o Sickle Cell Disease –

• Agios announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its mitapivat sickle cell disease supplemental New Drug Application (sNDA) by three months, from November 1, 2026, to February 1, 2027⁷.

• The FDA recently requested additional information to evaluate whether a REMS is necessary for mitapivat in sickle cell disease. The FDA classified Agios' response to this information request as a major amendment to the sNDA, resulting in the three-month review extension.

• Agios will continue its labeling discussions with the FDA as part of the ongoing sNDA review, including elements of a potential REMS.

• American Society of Hematology (ASH) Annual Meeting and Exposition (ASH 2026) – o Agios announced that 14 abstracts led by Agios and external collaborators have been accepted for presentation and publication at ASH 2026, taking place December 12-15, 2026, in New Orleans, Louisiana. These include three oral presentations featuring new data across mitapivat clinical programs.

o New clinical data from the RISE UP Phase 3 trial of mitapivat in sickle cell disease shows durable hemoglobin improvements for up to 115 weeks (over two y