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Agios Reports Business Highlights and Third Quarter 2019 Financial Results
TIBSOVO® Net Revenue of $17.4 Million; 27% Growth from Q2 2019
Reported Positive Phase 3 ClarIDHy Results for TIBSOVO® in Previously Treated IDH1 Mutant Cholangiocarcinoma; sNDA Submission Planned by Year-End
Presented Data from Single Agent Dose-Escalaton Arm of the Phase 1 Study of AG-270 in MTAP Deleted Tumors; Combination Arms with Taxanes in Non-Small Cell Lung Cancer and Pancreatic Cancer Initiated
Published Updated DRIVE PK Data for Mitapivat in PK Deficiency in New England Journal of Medicine; Updated Data from Extension Phase to be Presented at American Society of Hematology Annual Meeting
CAMBRIDGE, Mass., October 31, 2019 -- 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, 2019.
The third quarter was marked by strong commercial execution, now a full year since the U.S. launch of TIBSOVO®, and several meaningful clinical updates spanning our early and late stage oncology programs that advance our strategy, said Jackie Fouse, Ph.D., chief executive officer at Agios. As we look ahead to the remainder of 2019, we are focused on achieving our remaining key milestones, including completing enrollment in our mitapivat PK deficiency pivotal program, establishing proof of concept for mitapivat in thalassemia, initiating our pivotal trial of vorasidenib in low-grade glioma and submission of the TIBSOVO® supplemental new drug application for IDH1 mutant cholangiocarcinoma. These milestones are critical steps toward realizing the value-creation potential for both our oncology and rare genetic disease portfolios in 2020 and beyond.
THIRD QUARTER 2019 HIGHLIGHTS & RECENT PROGRESS
Presented data from the single agent dose-escalation portion of the ongoing Phase 1 study of AG-270 in patients with methylthioadenosine phosphorylase (MTAP)-deleted tumors at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in October. The data demonstrated that AG-270 induces reductions in the biomarkers of methionine adenosyltransferase 2A (MAT2A) inhibition, notably plasma concentrations of S-adenosylmethionine (SAM) and tumor levels of symmetrically demethylated arginine (SDMA), at well tolerated doses.
Presented results from the Phase 3 ClarIDHy study of TIBSOVO® in previously treated isocitrate dehydrogenase-1 (IDH1) mutant cholangiocarcinoma at the European Society for Medical Oncology Congress in September, demonstrating significant improvement in progression free survival compared to placebo.
Initiated two combination arms for the Phase 1 study of AG-270 in MTAP-deleted tumors, one evaluating AG-270 in combination with docetaxel in MTAP-deleted second-
The following information was filed by Agios Pharmaceuticals Inc (AGIO) on Thursday, October 31, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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