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Agios Reports Third Quarter 2018 Financial Results
Supplemental New Drug Application Submission for Single Agent TIBSOVO® (ivosidenib) in Newly Diagnosed IDH1m AML Patients Not Eligible for Standard Treatment Planned by the End of January 2019
Enrollment for Phase 3 AGILE Trial of Ivosidenib Combination with Azacitidine in Newly Diagnosed AML Patients Not Eligible for Intensive Chemotherapy Expected to Complete in 2020 with Revised Primary Endpoint
Mitapivat Pivotal Trials ACTIVATE and ACTIVATE-T in Adults with PK Deficiency Expected to Complete Enrollment in 2019
TIBSOVO® Launch in R/R IDH1m AML On-track;
Reported Revenue of $4.5M in First Partial Quarter of Launch
CAMBRIDGE, Mass., November 1, 2018 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, 2018.
On the heels of the third quarter U.S. approval of TIBSOVO®, our first wholly owned precision medicine, we remain focused on executing on our remaining 2018 milestones and continuing to create value from our portfolio, said David Schenkein, M.D., chief executive officer at Agios. Based on regulatory discussions, we are accelerating our frontline strategy in IDH1m AML with the planned submission of an sNDA expanding TIBSOVO®s label to newly diagnosed AML patients not eligible for standard treatment and a shorter enrollment timeline for the Phase 3 AGILE trial. In addition, we continue to activate new sites globally for our pivotal PK deficiency program and accrue patients in the dose-escalation portion of the Phase 1 study in MTAP-deleted tumors. We believe these programs coupled with our robust preclinical pipeline, support our next phase of growth toward becoming a fully integrated, sustainable biopharmaceutical company.
THIRD QUARTER & RECENT 2018 HIGHLIGHTS
Launched TIBSOVO® (ivosidenib) for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by a test approved by the U.S. Food and Drug Administration (FDA).
Awarded the U.S. Prix Galien Award for Best Pharmaceutical Product of 2018 for IDHIFA® (enasidenib), an isocitrate dehydrogenase-2 (IDH2) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an IDH2 mutation as detected by a test approved by the FDA. Each year, the Prix Galien USA Committee recognizes outstanding achievements in improving the human condition through the development of innovative therapies.
The following information was filed by Agios Pharmaceuticals Inc (AGIO) on Thursday, November 1, 2018 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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