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Agios Reports Fourth Quarter and Full Year 2018 Financial Results
Strong Launch of TIBSOVO® Continues with Net Revenue of $9.4M for the Fourth Quarter and $13.8M for Full Year 2018
Phase 3 ClarIDHy Trial of TIBSOVO® in Second Line or Later Cholangiocarcinoma Fully Enrolled
AG-270 Preclinical Data Accepted for Presentation at AACR; Data from Perioperative Study of TIBSOVO® and Vorasidenib in Low Grade Glioma Submitted for Presentation at ASCO
Dr. Jackie Fouse Assumed Role as Chief Executive Officer on Feb. 1, 2019
CAMBRIDGE, Mass., February 14, 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 fourth quarter and year ended December 31, 2018. In addition, Agios highlighted select 2019 corporate milestones and data presentations for its clinical development programs.
Im excited to join the Agios team on the heels of a transformational year for the company. During 2018, we launched our first wholly owned oncology medicine, expanded our clinical programs across both oncology and rare genetic diseases, and continued to advance our robust research pipeline, said Jackie Fouse, Ph.D. We start 2019 with a strong foundation on which to build and with the opportunity to make a meaningful impact on patients lives and our business. Our objectives for this year focus on broadening the potential of our IDH inhibitors in AML and solid tumors, advancing mitapivat and AG-270 through clinical development, and remaining steadfast in our pursuit of great science.
KEY UPCOMING MILESTONES
The company plans to achieve the following key milestones in 2019:
Potential FDA approval of the supplemental new drug application (sNDA) for single agent TIBSOVO® (ivosidenib) for the treatment of patients with newly diagnosed AML with an IDH1 mutation who are not eligible for standard therapy and subsequent launch in this indication in the U.S.
Submit an sNDA to the FDA for TIBSOVO® for second line or later IDH1 mutant cholangiocarcinoma by year-end.
Initiate a registration-enabling Phase 3 study of vorasidenib (AG-881) in low-grade glioma with an IDH1 mutation by year-end.
Determine recommended dose of AG-270, a first-in-class methionine adenosyltransferase 2a (MAT2A) inhibitor, in methylthioadenosine phosphorylase (MTAP)-deleted tumors; initiate expansion arms, including a single-agent arm in a variety of MTAP-deleted cancers and a combination arm in a solid tumor in the first half of 2019.
The following information was filed by Agios Pharmaceuticals Inc (AGIO) on Thursday, February 14, 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-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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