Exhibit 99.1
Agios Highlights Key 2019 Initiatives to Broaden Potential for Late-Stage Cancer and Rare Genetic Disease Programs to Build Long-Term Value
– Expanding the Label for TIBSOVO®: Supplemental New Drug Application (sNDA) Submitted for TIBSOVO® as Monotherapy for Patients with Newly Diagnosed AML with an IDH1 Mutation Ineligible for Standard Therapy; Approval Expected in 2019 –
– IDH1m Solid Tumor Opportunity Advancing: sNDA for TIBSOVO® in Second-line or Later Cholangiocincoma Expected byYear-End; Phase 3 Trial in Low Grade Glioma with Vorasidenib(AG-881) Expected to Begin byYear-End –
– Mitapivat PK Deficiency Pivotal Program On Track to Complete Enrollment byYear-End; Clinical Program Expanded with Initiation of Phase 2 Study in Thalassemia and Plan to Pursue Development in Pediatric PK Deficiency –
– Clinical Development of MAT2A InhibitorAG-270 Advancing into Expansion Arms in 1H 2019; Phase 1 Dose-Escalation Data to be Presented in 2H 2019 –
SAN FRANCISCO, January 7, 2019— Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today summarized key 2019 initiatives in conjunction with its presentation at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco. The company will webcast its presentation today at 9:30 a.m. PT (12:30 p.m. ET) at investor.agios.com.
“During 2018, just ten years after the founding of Agios, we achieved approval of our second internally discovered oncology medicine, launched a robust registrational program in PK deficiency and successfully opened the company’s seventh IND,” said David Schenkein, M.D., chief executive officer at Agios. “Our validated research platform and proven drug development strategy are poised to help drive future growth across our oncology and rare genetic disease portfolios. Our priorities for 2019 include expanding the reach of our IDH inhibitors into the frontline AML and solid tumor settings, completing enrollment in two pivotal studies of mitapivat and exploring the utility of PKR activators in other hemolytic anemias, and furthering clinical development forAG-270 in MTAP deleted tumors andAG-636 in lymphoma.”
The company plans to achieve the following milestones in 2019.
Cancer:
| • | | 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. |
| • | | Submit a sNDA to the FDA for TIBSOVO® for second line or later IDH1m cholangiocarcinoma byyear-end. |