Agios Pharmaceuticals Inc Stock Price, News & Analysis

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.

Agios Pharmaceuticals (NASDAQ: AGIO) has submitted a New Drug Application (NDA) to the FDA for mitapivat, targeting adults with pyruvate kinase (PK) deficiency, a chronic hemolytic anemia with serious complications. This marks a pivotal step as no therapies currently exist for PK deficiency. The NDA is based on two pivotal studies, ACTIVATE and ACTIVATE-T, showcasing long-term safety and efficacy. Agios aims to address significant unmet needs in this patient community. Mitapivat is not yet approved for any use.

Agios Pharmaceuticals announced positive results from its Phase 2 study of mitapivat in adults with non-transfusion dependent α- or β-thalassemia. The primary endpoint was met, with 80% of patients showing a hemoglobin increase of ≥1.0 g/dL during Weeks 4-12. Mitapivat was well tolerated, with a safety profile consistent with previous studies. The trial involved 20 patients—5 with α-thalassemia and 15 with β-thalassemia. The company plans to initiate two Phase 3 studies in the second half of 2021, focusing on treatment options for those with thalassemia.

Agios Pharmaceuticals (NASDAQ: AGIO) announced its plan to file for regulatory approval for mitapivat, a therapy for pyruvate kinase (PK) deficiency, in the U.S. this quarter and in the EU by mid-2021. Results from the Phase 3 ACTIVATE and ACTIVATE-T studies indicate mitapivat significantly improved hemoglobin levels and reduced transfusion burdens in adults with PK deficiency. With a favorable safety profile, the findings highlight mitapivat's potential as the first disease-modifying treatment for this condition. An investor webcast is scheduled for later today.

Agios Pharmaceuticals will present clinical data on its drug mitapivat at the European Hematology Association Annual Congress from June 9-17, 2021. Significant findings will be shared from Phase 3 studies on adults with pyruvate kinase deficiency, both transfusion-dependent and non-transfusion-dependent. Two oral presentations and several poster presentations will be made, highlighting the drug's effectiveness. An investor webcast is scheduled for June 11, 2021, to discuss these findings in detail, emphasizing Agios' commitment to addressing genetically defined diseases.

Agios Pharmaceuticals (NASDAQ: AGIO) announced significant developments in their recent press release, including the completion of the $1.8 billion sale of their oncology portfolio to Servier. This sale, closed on March 31, 2021, allows Agios to focus on genetically defined diseases. The company plans to file for regulatory approval of mitapivat for PK deficiency in the U.S. this quarter and in the EU mid-2021. Financially, Agios reported a net income of $1.9 billion for Q1 2021, a major increase from a net loss of $40.3 million in Q1 2020, alongside a robust cash position of $2.4 billion.

Agios Pharmaceuticals (NASDAQ: AGIO) will host a conference call and live webcast on April 29, 2021, at 8:00 a.m. ET to disclose its Q1 2021 financial results and share business highlights. The call can be accessed by calling 1-877-377-7098 for domestic or 1-631-291-4547 for international participants, using conference ID 4497151. The event will be available for replay on the company’s website after the live broadcast. Agios is focused on developing therapies for genetically defined diseases, with its leading candidate, mitapivat, targeting hemolytic anemias.

Agios Pharmaceuticals (NASDAQ: AGIO) has finalized a $1.8 billion sale of its oncology portfolio to Servier Pharmaceuticals. Following shareholder approval, the transaction allows Agios to focus on advancing its genetically defined disease pipeline, particularly mitapivat, which targets conditions like PK deficiency, thalassemia, and sickle cell disease. Additionally, Agios repurchased approximately 10% of its shares from Bristol-Myers Squibb for $344.5 million, funded by proceeds from the sale. Future milestones include regulatory filings and Phase 3 trials in 2021.