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Agios Pharmaceuticals, Inc. - AGIO STOCK NEWS

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 biopharmaceutical company at the forefront of pioneering therapies for rare diseases, focusing on cellular metabolism and precision medicine. Based in Cambridge, Massachusetts, Agios is dedicated to discovering and developing breakthrough medications that target cancer, rare genetic metabolic disorders, and metabolic immuno-oncology. The company's core mission is to create transformative small-molecule medicines with a precision approach, enabling genetically or biomarker-defined patient populations to benefit from early proof-of-concept in clinical development.

Agios boasts a robust clinical pipeline, with significant advancements in its leading PK activator, mitapivat. Recent achievements include the Phase 3 ENERGIZE and ENERGIZE-T studies of mitapivat in thalassemia, demonstrating statistically significant results in reducing transfusion burdens in transfusion-dependent patients. The company is preparing for FDA submissions based on these promising outcomes, aiming to deliver the first oral treatment option for thalassemia patients.

Financially, Agios reported a net revenue of $8.2 million for the first quarter of 2024 from PYRUKYND® (mitapivat) sales, reflecting a 15% increase over the previous quarter. The company's strong cash position, with $714.3 million in cash, cash equivalents, and marketable securities as of March 31, 2024, ensures support for ongoing programs and potential pipeline expansion into 2026. Agios also anticipates a significant financial milestone with potential FDA approval of vorasidenib, expected to bring in $1.1 billion from upfront and milestone payments.

Agios' commitment to diversity and inclusion extends beyond its internal team to its clinical trials, aiming to build trust and support among diverse patient communities. The company’s strategic partnerships and collaborations further reinforce its mission to innovate and deliver life-changing therapies.

To stay updated on the latest developments and financial news about Agios Pharmaceuticals, visit their official website.

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Agios Pharmaceuticals (NASDAQ: AGIO) has announced the appointments of Rahul Ballal, Ph.D., and Cynthia Smith to its board of directors. This move aims to strengthen the company's leadership as it focuses on advancing therapies for genetically defined diseases. Dr. Ballal brings over 15 years of experience in business development and hemolytic anemias, while Ms. Smith has 25 years of expertise in commercial strategy and product launches. The company continues to push forward its clinical pipeline, including treatments for conditions like sickle cell disease and thalassemia.

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Agios Pharmaceuticals (NASDAQ: AGIO) announced promising results from the Phase 2 study of PYRUKYND® (mitapivat) for treating non-transfusion-dependent α- and β-thalassemia, published in The Lancet. The study showed that 80% of patients experienced a hemoglobin increase of ≥1.0 g/dL from baseline, and significant safety results aligned with previous findings. Agios is actively enrolling subjects for the Phase 3 ENERGIZE studies to further investigate the drug's efficacy. The potential first oral therapy for thalassemia could transform treatment options for patients suffering from this debilitating condition.

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Agios Pharmaceuticals has announced the grant of inducement equity awards to its new CEO, Brian Goff, effective August 8, 2022. This grant includes a nonstatutory option for 561,083 shares, 68,073 restricted stock units, and 170,183 performance stock units, all aimed at incentivizing Mr. Goff's commitment to the company. The option price is set at $29.38 per share, aligning with the closing price on the announcement date. The awards are part of Agios's strategy to attract and retain top executive talent.

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Agios Pharmaceuticals reported $3.1 million in U.S. net revenue for PYRUKYND® in Q2 2022, marking its first full quarter of sales post-FDA approval. The company announced a leadership transition with Brian Goff becoming CEO on August 8, 2022, succeeding Jackie Fouse, who will serve as Chair of the Board. Agios has $1.1 billion in cash and marketable securities as of June 30, 2022, supporting its growth strategy. The company is enrolling patients in five pivotal studies for PYRUKYND® in various blood disorders, aiming for significant milestones by year-end.

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Agios Pharmaceuticals (NASDAQ: AGIO) announced a conference call scheduled for August 4, 2022, at 8:00 a.m. ET, to discuss its Q2 2022 financial results and business updates. Investors can access the live webcast on the company's website, with an archived version available post-event. Agios focuses on therapies for genetically defined diseases and markets a first-in-class pyruvate kinase activator for PK deficiency. The company is also advancing multiple investigational medicines targeting various disorders including sickle cell disease and MDS-associated anemia.

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Agios Pharmaceuticals (NASDAQ: AGIO) announced leadership changes effective August 8, 2022, with Jackie Fouse transitioning from CEO to Chair of the Board and Brian Goff appointed as the new CEO. Fouse highlighted Agios's success in divesting its oncology portfolio, launching its first genetically defined disease medicine, and initiating pivotal clinical trials. Goff comes with over 30 years of biopharmaceutical experience and aims to advance therapies for rare diseases, leveraging Agios's strong pipeline. This leadership transition is seen as a strategic move to enhance focus on genetically defined diseases.

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Agios Pharmaceuticals (NASDAQ: AGIO) recently shared positive results from its Phase 3 ACTIVATE study and extension studies for PYRUKYND® (mitapivat) in treating adult patients with pyruvate kinase deficiency (PK deficiency). Approximately 36% of treated patients achieved normal hemoglobin levels at least once. Patients reported significant improvements in PK deficiency symptoms including jaundice and fatigue. The therapy, which received FDA approval in February 2022, is also under review by the EMA. Agios is focused on enhancing treatment strategies and managing the complications associated with PK deficiency.

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Agios Pharmaceuticals (NASDAQ: AGIO) announced a leadership transition as Sarah Gheuens, M.D., Ph.D., will become Head of R&D and Chief Medical Officer, while Bruce Car, Ph.D., steps down. The company will focus on late lead-optimization programs and aims to save $40-50 million annually starting in 2023. This evolution prioritizes sustainable pipeline growth and strategic in-licensing of promising assets. Agios expects its cash reserves will support its operations and growth without needing additional equity financing.

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Agios Pharmaceuticals will present new patient-reported outcomes from its ACTIVATE Phase 3 Study of PYRUKYND (mitapivat) in adults with pyruvate kinase deficiency at the European Hematology Association Annual Congress from June 9-12, 2022. Key highlights include long-term normalization of hemoglobin levels and reduced transfusion needs. Additional data from the ESTIMATE Phase 2 Study in sickle cell disease will also be shared. An investor webcast is set for June 13, 2022, at 8 a.m. ET to review selected data.

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Agios Pharmaceuticals (NASDAQ: AGIO) is set to present at the RBC Capital Markets Global Healthcare Conference on May 17, 2022, at 10:30 a.m. ET. The presentation will focus on Agios's pioneering work in therapies for genetically defined diseases and its leadership in cellular metabolism. A live webcast can be accessed via their website, with an archived replay available for two weeks. Agios develops treatments for conditions like pyruvate kinase deficiency, with a strong clinical pipeline addressing thalassemia, sickle cell disease, and more.

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FAQ

What is the current stock price of Agios Pharmaceuticals (AGIO)?

The current stock price of Agios Pharmaceuticals (AGIO) is $35.42 as of December 20, 2024.

What is the market cap of Agios Pharmaceuticals (AGIO)?

The market cap of Agios Pharmaceuticals (AGIO) is approximately 2.0B.

What does Agios Pharmaceuticals specialize in?

Agios Pharmaceuticals focuses on developing transformative small-molecule medicines for cancer, rare genetic metabolic disorders, and metabolic immuno-oncology.

What are some recent achievements of Agios Pharmaceuticals?

Agios has recently reported significant results from the Phase 3 ENERGIZE and ENERGIZE-T studies of mitapivat in thalassemia, showing a reduction in transfusion burdens for patients.

What is the financial status of Agios Pharmaceuticals?

As of March 31, 2024, Agios reported $8.2 million in net revenue from PYRUKYND® sales for the first quarter, with a strong cash position of $714.3 million.

What is mitapivat?

Mitapivat is a pyruvate kinase (PK) activator developed by Agios to treat hemolytic anemia in patients with pyruvate kinase deficiency and is under study for thalassemia and sickle cell disease.

What is the significance of the ENERGIZE-T study results?

The ENERGIZE-T study demonstrated that mitapivat significantly reduced transfusion burdens for patients with transfusion-dependent thalassemia, achieving all primary and key secondary endpoints.

How does Agios support diversity in clinical trials?

Agios prioritizes diversity by designing inclusive clinical trial protocols, building trust within diverse patient communities, and supporting trial awareness to ensure diverse participation.

What are some key upcoming milestones for Agios in 2024?

Agios plans to report topline data from the Phase 3 ENERGIZE-T study, complete enrollment in the RISE UP study for sickle cell disease, and file for regulatory approval of mitapivat in thalassemia by the end of 2024.

What strategic partnerships does Agios have?

Agios has strategic collaborations, including an agreement with Royalty Pharma for rights to its vorasidenib royalties, adding significant financial flexibility for the company's future endeavors.

What is Agios' approach to ESG?

Agios publishes an annual ESG report highlighting its commitments and actions in diversity, equity, inclusion, and strong corporate governance, aligning with global standards and goals.

How can I stay updated on Agios Pharmaceuticals?

For the latest news and updates, visit Agios Pharmaceuticals' official website at www.agios.com.

Agios Pharmaceuticals, Inc.

Nasdaq:AGIO

AGIO Rankings

AGIO Stock Data

2.03B
55.12M
1.51%
107.78%
7.98%
Biotechnology
Pharmaceutical Preparations
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United States of America
CAMBRIDGE