AGIO

Agios Pharmaceuticals NASDAQ: AGIO reported record third-quarter product revenue as its thalassemia drug AQVESME continued its U.S. launch, while the company prepares for a delayed regulatory decision on the drug's use in sickle cell disease.

Agios Pharmaceuticals (AGIO) came out with a quarterly loss of $1.09 per share versus the Zacks Consensus Estimate of a loss of $1.32. This compares to a loss of $1.78 per share a year ago.

Mitapivat (PYRUKYND® and AQVESME®) delivered worldwide net revenues of $55.4 million in third quarter of 2026, more than four times the $12.9 million reported in third quarter of 2025 Strong U.S. demand for AQVESME in thalassemia continues, with 619 cumulative prescriptions with completed start forms from REMS-certified physicians, plus 48 additional prescriptions with start forms in process as of September 30, 2026 New PDUFA goal date for mitapivat sickle cell disease sNDA set for February 1, 2027; company is launch-ready and in labeling discussions with FDA 14 abstracts accepted at ASH 2026, including new clinical data for mitapivat in sickle cell disease and for AG-236 in polycythemia vera, highlighting the breadth and depth of Agios' rare hematology portfolio $907.0 million in cash, cash equivalents, and marketable securities as of September 30, 2026, fully funding commercial launches and pipeline programs; company is targeting non-GAAP profitability in 2028 CAMBRIDGE, Mass., Nov. 05, 2026 (GLOBE NEWSWIRE) -- 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.

Agios announces new clinical data across company's rare hematology portfolio that will be featured in oral and poster presentations during ASH 2026.

Agios Pharmaceuticals stock fell >15% after the FDA extended the mitapivat sNDA PDUFA date for sickle cell disease to February 2027. Mitapivat's efficacy in SCD is mixed—endpoint for pain crises not met, but strong reductions in transfusion burden demonstrated. The FDA's delay centers on safety and REMS considerations, not efficacy; no new hepatocellular injury cases were reported in updated safety data.

FDA recently requested additional information to evaluate whether a REMS is necessary for mitapivat in sickle cell disease FDA classified Agios' response to the information request as a major amendment to the mitapivat sNDA, resulting in a three-month review extension Mitapivat sNDA was submitted under the FDA's accelerated approval pathway and granted Priority Review, with an original PDUFA goal date of November 1, 2026 Agios will continue its labeling discussions with the FDA as part of the ongoing sNDA review, including elements of a potential REMS CAMBRIDGE, Mass., Oct. 30, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for the supplemental New Drug Application (sNDA) for mitapivat, an oral pyruvate kinase (PK) activator, in sickle cell disease.

Agios Pharmaceuticals (AGIO) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Agios faces a narrower growth path as tebapivat setbacks shift focus to mitapivat sales, SCD expansion and regulatory prospects.

AGIO's mitapivat is driving growth as Aqvesme gains traction, while an SCD opportunity and pipeline setbacks increase its importance.

Agios is leveraging mitapivat's commercial platform across PK deficiency, thalassemia, and potentially sickle cell disease to build a durable rare-disease franchise. Thalassemia launch drove Q2 2026 mitapivat revenue to $44.7M, up 259% YoY, with strong payer coverage and operational leverage emerging. AGIO's $965M cash position supports pipeline expansion and mitigates near-term dilution risk ahead of the November 1, 2026, PDUFA for mitapivat in sickle cell.