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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) will host a conference call and live webcast on February 23, 2023, at 8:00 a.m. ET to discuss its fourth quarter and year-end 2022 financial results. The event will be accessible via the Investors section on Agios’s official website. The company is known for its role in cellular metabolism and its marketing of a first-in-class pyruvate kinase activator for adults with PK deficiency, a rare hemolytic anemia. Agios is also advancing a clinical pipeline targeting various blood disorders, including sickle cell disease and thalassemia.

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Agios Pharmaceuticals (Nasdaq: AGIO) announced its strategic vision for 2023 and beyond, focusing on pivotal trials in rare hematological diseases. They are on track for potential FDA approvals for PYRUKYND in thalassemia in 2025 and sickle cell disease in 2026. With a strong cash position, Agios aims to complete its ongoing programs and expand its pipeline towards cash-flow positivity. Key milestones include enrolling half of patients in ongoing studies and presenting data at the J.P. Morgan Healthcare Conference on January 11, 2023.

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Agios Pharmaceuticals (Nasdaq: AGIO) announced the grant of inducement equity awards to newly appointed Chief Commercial Officer, Tsveta Milanova, effective January 3, 2023. The awards include a nonstatutory stock option for 135,682 shares at an exercise price of $27.53, restricted stock units for 25,426 shares, and performance stock units for 10,897 shares. The option vests over four years, while restricted stock units vest annually for three years. These grants comply with Nasdaq Listing Rule 5635(c)(4), indicating their significance in Milanova's employment.

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Agios Pharmaceuticals, a leader in rare disease therapies, will present at the 41st Annual J.P. Morgan Healthcare Conference on January 11, 2023, at 7:30 a.m. PT. The presentation will be accessible via a live webcast on the company’s website, with a replay available for at least two weeks afterward. Agios markets a first-in-class pyruvate kinase activator and is advancing a clinical pipeline focused on diseases like sickle cell disease and thalassemia. For more information, visit www.agios.com.

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Agios Pharmaceuticals (NASDAQ: AGIO) presented data at the 64th ASH Annual Meeting, highlighting the long-term efficacy and safety of PYRUKYND (mitapivat) in adults with pyruvate kinase deficiency. The data indicates sustained improvements in hemoglobin levels and reduced transfusion burdens over periods up to 38 months.

These findings support ongoing studies in pediatric populations, with expectations of similar benefits in children. PYRUKYND has been recognized as the first oral treatment for this rare disease with FDA and EMA approvals, enhancing Agios's position in hematology.

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Agios Pharmaceuticals (NASDAQ: AGIO) is actively enrolling patients in its Phase 3 ENERGIZE and ENERGIZE-T studies evaluating PYRUKYND® (mitapivat) for adults with α- and β-thalassemia. The latest data presented at the 64th American Society of Hematology Annual Meeting demonstrated sustained improvements in hemoglobin concentrations and a well-tolerated safety profile for up to 72 weeks. Agios emphasizes the urgent need for new therapies for thalassemia, as current options are limited. An investor event will occur on Dec. 12, 2022, to discuss these developments further.

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Agios Pharmaceuticals (Nasdaq: AGIO) announced the appointment of Tsveta Milanova as chief commercial officer, effective January 3, 2023. She will succeed Richa Poddar, who has held the position since 2016. Milanova brings over 20 years of experience in biopharmaceuticals, having worked at Alexion and Celgene. Her expertise in launching therapies for rare diseases is expected to enhance Agios' commercial strategy as the company seeks to expand its portfolio and market reach, particularly following the approval of its PK activator for adults with PK deficiency.

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Agios Pharmaceuticals (NASDAQ: AGIO) will present at the Bank of America 2022 Virtual Biotech SMID Cap Conference on December 7, 2022, at 11:25 a.m. ET. The presentation will be accessible via a live webcast on the company's website under the "Events & Presentations" section. A replay will be available for at least two weeks post-event. Agios focuses on therapies for rare diseases and is known for its first-in-class pyruvate kinase (PK) activator for adults with PK deficiency. The company is advancing its clinical pipeline for various hematological conditions.

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Agios Pharmaceuticals has received EU marketing authorization for PYRUKYND® to treat pyruvate kinase (PK) deficiency in adults, marking it as the first disease-modifying therapy for this rare blood disorder. The approval follows positive results from pivotal studies, ACTIVATE and ACTIVATE-T, demonstrating significant clinical benefits, including increased hemoglobin levels and reduced transfusion needs. Agios aims to expand access via a global managed access program, and has plans to pursue further indications in pediatric patients and other diseases.

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Agios Pharmaceuticals (NASDAQ: AGIO) presented significant clinical data at the 64th ASH Annual Meeting, highlighting the long-term benefits of PYRUKYND® in adults with Pyruvate Kinase (PK) deficiency. Results showed improved hemoglobin levels, reduced transfusion needs, and better patient-reported outcomes. Additionally, new findings for the investigational PK activator AG-946 support its Phase 2 study in Myelodysplastic Syndromes (MDS)-associated anemia. An investor event is scheduled for Dec. 12, 2022, at 7 a.m. ET to discuss these developments.

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FAQ

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

The current stock price of Agios Pharmaceuticals (AGIO) is $55.54 as of November 21, 2024.

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

The market cap of Agios Pharmaceuticals (AGIO) is approximately 3.1B.

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

3.10B
55.12M
1.51%
106.87%
7.61%
Biotechnology
Pharmaceutical Preparations
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United States of America
CAMBRIDGE