Business
Agios Reports Business Highlights and Third Quarter 2020 Financial Results
– Third Quarter TIBSOVO® Net Revenue of $31.7 Million; Company Narrows 2020 TIBSOVO® Net U.S. Revenue Guidance to $113–115 Million – – Topline Data from the
About this update from Agios Pharmaceuticals, Inc.
[{"type":"text","content":"– Third Quarter TIBSOVO® Net Revenue of $31.7 Million; Company Narrows 2020 TIBSOVO® Net U.S. Revenue Guidance to $113–115 Million –\n – Topline Data from the Mitapivat Phase 3 ACTIVATE Trial in Non-Transfusion Dependent PK Deficiency Expected by Year-End; Topline Phase 3 ACTIVATE-T Data Expected in Q1 2021 – – Reported Positive Overall Survival Trend in ClarIDHy Phase 3 Trial of TIBSOVO® in Advanced Cholangiocarcinoma; Company Plans to Submit Supplemental New Drug Application in Q1 2021 – CAMBRIDGE, Mass., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today reported business highlights and financial results for the third quarter ended September 30, 2020. “In the third quarter, we made significant strides toward executing against our key 2020 priorities and getting our medicines to patients who need them,” said Jackie Fouse, Ph.D., chief executive officer at Agios. “Most notably, we generated mature overall survival data from our Phase 3 ClarIDHy study of TIBSOVO® in previously treated cholangiocarcinoma, prepared for topline data readouts from our two global Phase 3 studies of mitapivat in pyruvate kinase deficiency and advanced our pivotal plans for mitapivat in thalassemia and sickle cell disease. We look forward to building on these achievements with a catalyst-rich fourth quarter and 2021.” THIRD QUARTER 2020 & RECENT HIGHLIGHTS TIBSOVO® (ivosidenib tablets) net sales of $31.7 million, an increase of 15% from the second quarter of 2020.Reported topline mature overall survival results from ClarIDHy Phase 3 study of TIBSOVO® in previously treated IDH1-mutant cholangiocarcinoma patients; submitted final data for presentation at the virtual American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI).Withdrew European Marketing Authorization Application (MAA) for TIBSOVO® in IDH1-mutant relapsed or refractory acute myeloid leukemia (AML) as a result of feedback from European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).Initiated Phase 1 healthy volunteers study of AG-946, a next-generation, orally available, small molecule activator of the metabolic enzyme pyruvate kinase-R (PKR).Appointed Jonathan Biller as chief financial officer, head of legal and corpo...