Business
Agios Reports Business Highlights and Third Quarter 2021 Financial Results
– Received FDA Priority Review for Mitapivat for the Treatment of Adults with Pyruvate Kinase (PK) Deficiency; PDUFA Date Set for Feb. 17, 2022 – – Initiated
About this update from Agios Pharmaceuticals, Inc.
[{"type":"text","content":"– Received FDA Priority Review for Mitapivat for the Treatment of Adults with Pyruvate Kinase (PK) Deficiency; PDUFA Date Set for Feb. 17, 2022 – – Initiated ENERGIZE and ENERGIZE-T Phase 3 Studies in Thalassemia – – Agios to Host Investor Day on Nov. 17 to Share Pipeline Updates and Commercial Launch Strategy for Mitapivat in PK Deficiency – CAMBRIDGE, Mass., Nov. 03, 2021 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat genetically defined diseases, today reported business highlights and financial results for the third quarter ended Sept. 30, 2021. “In the third quarter, we have continued our strong clinical and operational execution. Following our NDA and MAA filings for mitapivat for adults with PK deficiency, the team is laser-focused on launch preparations in this indication, as well as on initiating three pivotal trials across thalassemia and sickle cell disease by year-end,” said Jackie Fouse, Ph.D., chief executive officer at Agios. “As we look ahead to the end of the year and to 2022, Agios is extremely well-positioned to enter our next phase of growth, with our first genetically defined disease commercial launch on the horizon, the expected initiation of three pivotal adult trials and two pediatric PK deficiency trials and a robust pipeline filled with optionality and possibility. We look forward to sharing more insights on our clinical and preclinical pipeline and our commercial launch efforts at our investor day in November.” THIRD QUARTER 2021 & RECENT HIGHLIGHTS Received Priority Review designation for the new drug application of mitapivat in PK deficiency by the U.S. Food and Drug Administration (FDA), accelerating review time from 10 months to six months from the day of filing acceptance; Prescription Drug User Fee Act (PDUFA) action date set for Feb. 17, 2022.Initiated first global trial sites for Phase 3 ENERGIZE and ENERGIZE-T studies of mitapivat in not regularly transfused and regularly transfused adults with α- or β-thalassemia.Continued start-up activities for the Phase 2/3 study of mitapivat in sickle cell disease. In collaboration with a global team of sickle cell disease patients and caregivers, developed study name – RISE UP – and unveiled it at the Sickle Cell Disease Association of America 49th Annual National Convention last month...