Agios Pharmaceuticals, Inc. - AGIO STOCK NEWS

Agios Pharmaceuticals (AGIO) has outlined its key milestones for 2022, focusing on the anticipated FDA decision for mitapivat as a treatment for adults with PK deficiency due in February. The company plans five pivotal clinical trials across thalassemia, sickle cell disease, and pediatric PK deficiency. Agios aims to enhance its clinical portfolio, including the novel PK activator AG-946. With a strong cash position, Agios targets cash-flow positivity while expanding its research pipeline, expecting to achieve significant regulatory approvals by 2026.

Agios Pharmaceuticals (NASDAQ: AGIO) will present at the virtual 40th Annual J.P. Morgan Healthcare Conference on January 12, 2022, at 7:30 a.m. ET. Interested parties can access the live webcast under the "Events & Presentations" section of their website. A replay will be available for at least two weeks post-presentation. Agios focuses on developing novel medicines for genetically defined diseases, with a notable drug candidate, mitapivat, being evaluated for hemolytic anemias.

Agios Pharmaceuticals (NASDAQ: AGIO) presented new data on mitapivat at the ASH Annual Meeting, highlighting its long-term effectiveness in treating adults with pyruvate kinase (PK) deficiency. According to the findings, patients maintained significant hemoglobin responses for up to 21.9 months, with 35% of those switching to mitapivat achieving similar outcomes. The drug demonstrated improvements in ineffective erythropoiesis and iron overload, while bone mineral density remained stable in most patients over 5.5 years. Mitapivat is under regulatory review in the U.S. and EU as a potential treatment for PK deficiency.

Agios Pharmaceuticals initiated global Phase 3 studies, ENERGIZE and ENERGIZE-T, to evaluate mitapivat for treating α- and β-thalassemia. This follows promising long-term results from a Phase 2 trial, showing sustained hemoglobin improvements and a well-tolerated safety profile over 72 weeks. The study involved 20 patients, with a mean hemoglobin increase of 1.5 g/dL at Week 60 and 1.7 g/dL at Week 72. Mitapivat is not yet approved.

An investor webcast is scheduled for Dec. 14, 2021, to discuss findings presented at the ASH Annual Meeting.

Agios Pharmaceuticals announced promising data regarding mitapivat in treating sickle cell disease, presented at the ASH Annual Meeting. The investigational drug shows potential for clinically meaningful outcomes, including improved anemia and reduced hemolysis. Key findings from studies indicate that 83.3% of trial participants achieved a significant increase in hemoglobin levels, with no serious adverse events reported. The Phase 2/3 RISE UP study has been initiated to evaluate mitapivat's efficacy and safety, alongside a virtual investor event scheduled for December 14, 2021.

Darrin Miles is set to leave Agios Pharmaceuticals (NASDAQ: AGIO) to pursue a Chief Executive Officer position at a private biotechnology company. Effective Dec. 6, 2021, Richa Poddar has been appointed as the new Chief Commercial Officer. Poddar has a strong background at Agios, contributing significantly to the oncology portfolio and preparing for the launch of mitapivat for pyruvate kinase deficiency. Agios is focused on developing innovative treatments for genetically defined diseases, with mitapivat being a key player in their pipeline.

Agios Pharmaceuticals (NASDAQ: AGIO) announced promising long-term safety and efficacy results for mitapivat in treating chronic hemolytic anemias like PK deficiency and thalassemia. Data from two investigator-sponsored studies supports advancing mitapivat for sickle cell disease. AG-946, a new candidate, showed dose-dependent efficacy in ATP and 2,3-DPG changes in a Phase 1 trial. Agios will present eight abstracts at the ASH Annual Meeting from Dec. 11-14, 2021, highlighting their advancements in these therapies. An investor webcast is scheduled for Dec. 14, 2021.

Agios Pharmaceuticals (AGIO) received FDA Priority Review for mitapivat, targeting adults with PK deficiency, with a PDUFA date of Feb. 17, 2022. The company has initiated Phase 3 ENERGIZE and ENERGIZE-T studies in thalassemia and plans to host an investor day on Nov. 17 to share pipeline updates. In Q3 2021, Agios reported a net loss of $88.8 million but improved its cash position to $1.4 billion, enabling future operations without additional equity raises. R&D expenses rose to $64 million, driven by new clinical trials.

Agios Pharmaceuticals (NASDAQ: AGIO) will hold a conference call on November 3, 2021, at 8:00 a.m. ET to discuss its third quarter 2021 financial results. The call will be accessible by phone and via a live webcast on Agios' website. The company is focused on developing medicines for genetically defined diseases, with its lead candidate, mitapivat, being evaluated for three distinct hemolytic anemias. A replay of the event will be available shortly after the conclusion.