Agios Pharmaceuticals Inc.

2 days ago · seekingalpha.com

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.

3 days ago · globenewswire.com

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.

4 days ago · zacks.com

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.

25 days ago · globenewswire.com

CAMBRIDGE, Mass., Oct. 08, 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 the company will host a conference call and live webcast on Thursday, November 5, 2026, at 8:00 a.m.

27 days ago · zacks.com

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

1 month ago · zacks.com

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

2 months ago · seekingalpha.com

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.

3 months ago · zacks.com

Agios tops Q2 revenue and earnings estimates as Aqvesme's launch and Pyrukynd sales fuel growth, while advancing its hematology pipeline.

3 months ago · seekingalpha.com

Agios Pharmaceuticals, Inc. (AGIO) Q2 2026 Earnings Call Transcript

3 months ago · marketbeat.com

Agios Pharmaceuticals NASDAQ: AGIO reported second-quarter 2026 mitapivat net revenue of $44.7 million, including $40.9 million in the United States and $3.8 million outside the U.S., as the company continued the U.S. thalassemia launch of AQVESME and prepared for a potential sickle cell disease approval later this year.