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Agios Reports Business Highlights and First Quarter 2019 Financial Results
Commercial Organization Launch Ready Ahead of June 21, 2019 PDUFA Action Date for Single Agent TIBSOVO® for IDH1m Newly Diagnosed AML
Updated Data from Phase 1 Studies of TIBSOVO® in Newly Diagnosed AML and First Data from Perioperative Study of TIBSOVO® and Vorasidenib Accepted for Presentation at ASCO
Broad Clinical Development Plan for Mitapivat Progressing with Pyruvate Kinase Deficiency Pivotal Studies Enrolling, First Patient Dosed in Phase 2 Thalassemia Study and NIH-Sponsored Sickle Cell Study to Initiate in 2019
$9.1M First Quarter Net Revenue for TIBSOVO®; March 31, 2019 Cash, Cash Equivalents and Marketable Securities was $707.8M; Provides Runway Through at Least the End of 2020
CAMBRIDGE, Mass., May 2, 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 first quarter ended March 31, 2019.
We continued to deliver significant progress across our oncology and rare genetic disease programs during the first quarter. Importantly, our U.S. commercial team is driving TIBSOVO® toward solid performance for its first full year on the market, and we are on track to achieve our internal forecast, said Jackie Fouse, Ph.D., chief executive officer at Agios. We made progress on expansion opportunities for TIBSOVO® across the frontline AML setting. FDA accepted our sNDA in newly diagnosed AML, the HOVON/AMLSG Phase 3 intensive chemotherapy combination study initiated, and we received Breakthrough Therapy Designation for the combination of TIBSOVO® and azacitadine. We also advanced our mitapivat program. Our two pivotal trials in pyruvate kinase deficiency remain on track to complete enrollment this year, we have dosed the first patient in our Phase 2 thalassemia study, and we now expect a NIH-sponsored study in sickle cell disease to initiate this year.
FIRST QUARTER 2019 HIGHLIGHTS & RECENT PROGRESS
Received FDA acceptance and Priority Review for the supplemental new drug application (sNDA) for single agent TIBSOVO® for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) mutation who are not eligible for standard therapy. The Prescription Drug User Fee Act (PDUFA) action date was set for June 21, 2019.
Presented updated data from the ongoing Phase 1 combination trial of TIBSOVO® with azacitidine in patients with newly diagnosed AML with an IDH1 mutation at the 17th International Symposium on Acute Leukemias.
Received Breakthrough Therapy designation from FDA for TIBSOVO® in combination with azacitidine for the treatment of newly diagnosed AML patients with an IDH1 mutation who are ³75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
The following information was filed by Agios Pharmaceuticals Inc (AGIO) on Thursday, May 2, 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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