Agios Pharmaceuticals, Inc. - AGIO STOCK NEWS

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.

Agios Pharmaceuticals (NASDAQ: AGIO) announced its participation in two upcoming investor conferences. The Citi’s 16th Annual Biopharma Virtual Conference will feature a panel on Sickle Cell and related conditions on September 10 at 12:30 p.m. ET. Additionally, the 2021 Cantor Virtual Global Healthcare Conference is scheduled for September 27 at 8:00 a.m. ET. Live webcasts will be available on their website, with replays accessible for at least two weeks post-event. Agios focuses on innovative treatments for genetically defined diseases, with its leading drug candidate, mitapivat, targeting hemolytic anemias.

Agios Pharmaceuticals announced on August 17, 2021, that the FDA has accepted its New Drug Application (NDA) for mitapivat, aimed at treating adults with pyruvate kinase deficiency. This NDA received a Priority Review designation, expediting the review process to a PDUFA date of February 17, 2022. Mitapivat is being positioned as a potential first disease-modifying therapy for this chronic condition, with the FDA’s designation indicating significant improvements in treatment.

Agios Pharmaceuticals (AGIO) recently completed regulatory submissions for mitapivat, targeting adults with Pyruvate Kinase deficiency in the U.S. and EU. The company presented positive Phase 3 study results for mitapivat at the EHA Virtual Congress, showing strong efficacy, including an 80% hemoglobin increase in thalassemia patients. Q2 2021 R&D expenses rose to $62 million, while net loss decreased to $86.2 million. Agios reported $1.7 billion in cash reserves, sufficient for ongoing operations and future developments, including two planned Phase 3 trials and a Phase 2/3 trial in sickle cell disease.

Agios Pharmaceuticals (NASDAQ: AGIO) has scheduled a conference call for July 29, 2021, at 8:00 a.m. ET to discuss its second quarter 2021 financial results and business highlights. The call will be accessible via telephone or live webcast through the company’s website. Agios specializes in developing medicines for genetically defined diseases, with its lead drug candidate, mitapivat, targeting hemolytic anemias.

Agios Pharmaceuticals (NASDAQ: AGIO) has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency for mitapivat, aimed at treating adults with pyruvate kinase deficiency. This follows a recent New Drug Application (NDA) to the FDA. Mitapivat is designed to offer a first-in-class therapy for this chronic hemolytic anemia, characterized by serious complications and no approved treatments currently available. The application is backed by pivotal study results and ongoing studies to evaluate long-term efficacy.

Agios Pharmaceuticals (NASDAQ: AGIO) has announced the launch of myAgios® patient support services for individuals with pyruvate kinase deficiency. This program connects patients and caregivers with dedicated Patient Support Managers, offering tailored support and educational resources. The initiative responds to the unique challenges faced by this rare disease community, aiming to improve care management. Additionally, a virtual webinar series will start on June 23, 2021, focusing on PK deficiency, enhancing community engagement and awareness.