Agios Pharmaceuticals (AGIO) announced that the FDA has accepted its supplemental new drug application (sNDA) seeking label expansion for its sole marketed drug, Pyrukynd, in thalassemia indication.A final decision is expected by Sep. 7, 2025. If approved, Pyrukynd will become the first oral therapy for use in all thalassemia subtypes. A commercial launch in this indication is expected before this year’s end.The sNDA is supported by data from two phase III studies, ENERGIZE and ENERGIZE-T, which evaluated P ...

CAMBRIDGE, Mass., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and pyruvate kinase (PK) activation pioneering therapies for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted the company’s supplemental New Drug Application (sNDA) for PYRUKYND® (mitapivat) for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia. The review classification for th ...

CAMBRIDGE, Mass., Jan. 03, 2025 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, today announced that its management team is scheduled to present at the 43rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2025, at 7:30 a.m. PT / 10:30 a.m. ET. The live webcast will be accessible on the Investors section of the company's website (www.agios.com) under the “Events & Presentations” tab. A ...

CAMBRIDGE, Mass., Dec. 18, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and pyruvate kinase (PK) activation pioneering therapies for rare diseases, today announced that the European Commission has adopted a positive decision for the designation of mitapivat, an oral, small molecule PK activator, as an orphan medicinal product (OMP) for the treatment of sickle cell disease. Earlier, in November 2020, the U.S. Food and Drug Administration (FDA) also gran ...

CAMBRIDGE, Mass., Dec. 18, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in cellular metabolism and pyruvate kinase (PK) activation pioneering therapies for rare diseases, today announced that the European Commission has adopted a positive decision for the designation of mitapivat, an oral, small molecule PK activator, as an orphan medicinal product (OMP) for the treatment of sickle cell disease. Earlier, in November 2020, the U.S. Food and Drug Administration (FDA) also grant ...

For those looking to find strong Medical stocks, it is prudent to search for companies in the group that are outperforming their peers. Has Agios Pharmaceuticals (AGIO) been one of those stocks this year? A quick glance at the company's year-to-date performance in comparison to the rest of the Medical sector should help us answer this question.Agios Pharmaceuticals is a member of the Medical sector. This group includes 1022 individual stocks and currently holds a Zacks Sector Rank of #3. The Zacks Sector Ra ...

Agios Pharmaceuticals, Inc. (AGIO) reported earnings of $16.22 per share for the third quarter of 2024, which missed the Zacks Consensus Estimate of $16.69. In the year-ago quarter, the company had reported a loss of $1.64 per share.The abovementioned earnings included a gain on the sale of contingent payments and a milestone payment from a gain on the sale of the oncology business. Excluding these items, the company incurred a loss of 15 cents per share.Earnings grew significantly year over year owing to a ...

Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) Q3 2024 Earnings Conference Call October 31, 2024 8:00 AM ET Company Participants Chris Taylor - Vice President, Investor Relations and Corporate Communications Brian Goff - Chief Executive Officer Sarah Gheuens - Chief Medical Officer and Head, R&D Tsveta Milanova - Chief Commercial Officer Cecilia Jones - Chief Financial Officer Conference Call Participants Greg Harrison - Scotiabank Alex Nackenoff - Raymond James Greg Renza - RBC Capital Markets Eric Schmidt - Ca ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-36014 AGIOS PHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 26-0662915 (State or Other Jurisdiction o ...

Agios Pharmaceuticals (AGIO) came out with quarterly earnings of $4.20 per share, missing the Zacks Consensus Estimate of $16.69 per share. This compares to loss of $1.64 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -74.84%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $1.58 per share when it actually produced a loss of $1.69, delivering a surprise of -6.96%.Over the last four quar ...