Welcome to our dedicated page for Agios Pharmaceuticals news (Ticker: AGIO), a resource for investors and traders seeking the latest updates and insights on Agios Pharmaceuticals stock.
Agios Pharmaceuticals Inc. (AGIO) is a leader in developing therapies for rare hematologic and genetic disorders through its groundbreaking work in cellular metabolism. This page provides investors and industry professionals with timely updates on AGIO’s clinical advancements, regulatory milestones, and strategic initiatives.
Discover official press releases covering AGIO’s progress in treating conditions like pyruvate kinase deficiency, thalassemia, and sickle cell disease. The curated news includes updates on clinical trials, FDA communications, research collaborations, and pipeline expansions. Each update is sourced to ensure accuracy and relevance for informed decision-making.
Key areas of coverage include novel therapeutic developments, regulatory submissions, and strategic partnerships that underscore AGIO’s role in advancing precision medicine. Bookmark this page to stay informed about the company’s contributions to transforming rare disease treatment through metabolic science.
Agios Pharmaceuticals (AGIO) announced significant results from the Phase 3 ACTIVATE-T trial for mitapivat in treating adults with pyruvate kinase (PK) deficiency. In the 24-week treatment period, 37% of patients achieved a ≥33% reduction in transfusion burden, while 22% were transfusion-free. The safety profile remained consistent with previous studies. Agios plans to file for regulatory approval in both the U.S. and EU in 2021, potentially leading to a commercial launch in 2022. This marks a promising step towards addressing treatment gaps in PK deficiency.
Agios Pharmaceuticals has provided a full analysis of final data from its Phase 3 ClarIDHy trial of TIBSOVO (ivosidenib tablets) for patients with previously treated IDH1-mutant cholangiocarcinoma. The analysis showed a median overall survival (OS) of 10.3 months for TIBSOVO compared to 7.5 months for placebo, though statistical significance was not achieved (p=0.093). A high crossover rate from placebo to TIBSOVO was noted. Agios plans to submit a supplemental new drug application in Q1 2021. The trial demonstrates potential for TIBSOVO as a treatment option for this aggressive cancer.
Agios Pharmaceuticals (NASDAQ: AGIO) aims to file for regulatory approval of Mitapivat for treating adults with pyruvate kinase deficiency in the U.S. by Q2 2021 and in the EU by mid-2021. Key milestones for 2021 include initiating pivotal trials for Mitapivat in thalassemia and sickle cell disease, and completing the sale of its oncology portfolio to Servier, generating up to $2 billion. The company’s strategic vision includes commercializing Mitapivat for three indications and achieving cash-flow positivity by 2025.
Agios Pharmaceuticals (NASDAQ:AGIO) announced its presentation schedule for the virtual 39th Annual J.P. Morgan Healthcare Conference on January 11, 2021, at 10:50 a.m. ET. Investors can access a live webcast of the event via the company's website, with a replay available for two weeks post-event. Agios is recognized for its focus on developing novel investigational medicines targeting cancer and genetically defined diseases, boasting a robust research pipeline alongside two approved oncology precision medicines.
Agios Pharmaceuticals announced a transformative strategic shift, focusing on its genetically defined disease portfolio, particularly mitapivat, a potential treatment for hemolytic anemias. The company is selling its oncology portfolio to Servier for up to $2.0 billion, comprising $1.8 billion upfront and $200 million in potential milestone payments. Post-transaction, Agios intends to return at least $1.2 billion to shareholders. The deal aims to bolster Agios' capital and advance its future treatments while enhancing Servier's oncology capabilities.
Agios Pharmaceuticals (NASDAQ: AGIO) announced positive results from the Phase 1 trial of mitapivat for sickle cell disease. The study demonstrated that 55% of patients achieved a hemoglobin increase of ≥1.0 g/dL, with a mean increase of 1.3 g/dL overall. The safety profile was consistent with previous studies, showing mostly Grade 1-2 adverse events. Based on these promising results, Agios plans to initiate a Pivotal Program for mitapivat in 2021. The company will discuss these findings in an investor webcast on December 8, 2020.
Agios Pharmaceuticals announced that its Phase 3 ACTIVATE trial of mitapivat for PK deficiency achieved its primary endpoint, with 40% of patients experiencing a significant hemoglobin increase of ≥1.5 g/dL, compared to none in the placebo group (p<0.0001). The safety profile aligns with prior data, and no adverse events led to discontinuation. Agios plans to seek regulatory approval in the U.S. and EU in 2021, with a potential launch in 2022. Topline results from the ACTIVATE-T trial are expected in Q1 2021.
Agios Pharmaceuticals (NASDAQ:AGIO) announced the launch of Anemia ID, a no-cost genetic testing program for patients with suspected hereditary anemias. This initiative aims to provide comprehensive diagnostic testing using a next-generation sequencing panel that explores over 50 genetic mutations linked to various anemia disorders. The program seeks to facilitate accurate diagnoses, thereby improving disease management and treatment options for patients. The testing is conducted by PerkinElmer Genomics, and all costs are covered by Agios.
Agios Pharmaceuticals (NASDAQ:AGIO) is set to present at the Piper Sandler 32nd Annual Virtual Healthcare Conference on December 2, 2020, at 2:00 p.m. ET. This event highlights Agios' commitment to advancing treatments in cancer and rare genetic diseases through its focus on cellular metabolism.
A live webcast will be available in the Investors section of the Agios website, with an archived replay accessible for two weeks post-presentation.
Agios Pharmaceuticals (NASDAQ: AGIO) announced that the FDA granted orphan drug designation to its PKR activator, mitapivat, for treating sickle cell disease. This designation highlights the significant unmet needs of this patient group. Mitapivat is an investigational oral drug aimed to enhance red blood cell energy and longevity by improving PKR enzyme activity. The company plans to initiate a Phase 3 study in 2021. Orphan drug designation provides benefits like market exclusivity upon approval, reduced FDA fees, and tax credits for clinical trials.
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