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Agios Reports Business Highlights and Second Quarter 2019 Financial Results
Strong Topline Performance for IDH Inhibitors: TIBSOVO® Net Revenue Increased 50% from Q1 2019 to $13.7M; IDHIFA® Royalty Increased to $2.7M
Achieved Important Expansion Opportunities for TIBSOVO® Including sNDA Approval in Frontline AML and Positive Phase 3 Trial in Previously Treated IDH1 Mutant Cholangiocarcinoma
AG-270 Phase 1 Dose Escalation Complete and Data Submitted to AACR-NOI-EORTC Conference; Program Advancing to Expansion Phase This Quarter
CAMBRIDGE, Mass., August 1, 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 second quarter ended June 30, 2019.
In the second quarter we demonstrated our ability to execute across all areas of our business. Our commercial team continues to deliver on the AML launch for TIBSOVO® and prepare for our first potential solid tumor launch on the heels of the positive ClarIDHy study in cholangiocarcinoma, said Jackie Fouse, Ph.D., chief executive officer at Agios. On the clinical side, we continued to broaden our IDH program into earlier lines of AML therapy and expand our PKR programs into new disease areas while enrolling the PK deficiency pivotal studies. In addition, we completed dose escalation in our AG-270 Phase 1 trial and are on track to initiate the next phase of development. The great progress we made during the quarter keeps us on track to deliver on our remaining 2019 milestones and drive further value across our portfolio.
SECOND QUARTER 2019 HIGHLIGHTS & RECENT PROGRESS
Received approval from the U.S. Food and Drug Administration (FDA) on May 2, 2019 for single agent TIBSOVO® for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) with an IDH1 mutation who are ³ 75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
Announced the Phase 3 ClarIDHy trial of TIBSOVO® in advanced previously treated cholangiocarcinoma patients with an IDH1 mutation met its primary endpoint, demonstrating improvement in progression-free survival by independent radiology review compared with patients who received placebo.
Presented updated data from the Phase 1 studies of TIBSOVO® in frontline AML, both as a monotherapy and in combination with azacitidine, and the first data from the perioperative study of TIBSOVO® and vorasidenib in glioma at the 2019 American Society of Clinical Oncology Annual Meeting. The data presentations can be found here.
Began dosing patients in the Phase 1 dose-escalation trial of AG-636, an inhibitor of the metabolic enzyme dihydroorotate dehydrogenase (DHODH), in advanced lymphoma.
Completed the single agent dose-escalation portion of the ongoing Phase 1 study of AG-270 in methylthioadenosine phosphorylase (MTAP)-deleted tumors.
The following information was filed by Agios Pharmaceuticals Inc (AGIO) on Thursday, August 1, 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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