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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 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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Agios Pharmaceuticals reported strong progress in Q3 2022, with net revenue of $3.5 million from the launch of PYRUKYND®, marking the second full quarter post-FDA approval. The company received a favorable opinion from the CHMP for PYRUKYND® to treat PK deficiency in adults and is on track for key enrollment milestones in pivotal studies. Leadership changes include the appointment of Cecilia Jones as CFO and new board members. As of September 30, 2022, Agios holds $1.0 billion in cash and marketable securities.

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Agios Pharmaceuticals has sold its rights to a 5% royalty on U.S. net sales of TIBSOVO® to Sagard Healthcare Partners for $131.8 million. TIBSOVO® is FDA-approved for treating patients with the IDH1 mutation in acute myeloid leukemia and cholangiocarcinoma. Agios retains potential future payments related to vorasidenib, including a $200 million milestone and 15% royalties on U.S. net sales. This transaction enhances Agios' financial flexibility, aiding in the launch of PYRUKYND® and ongoing pivotal studies.

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Agios Pharmaceuticals (NASDAQ: AGIO) will host a conference call and live webcast on November 3, 2022, at 8:00 a.m. ET to discuss its third quarter 2022 financial results and business updates. The webcast will be accessible on the company’s website in the Investors section and will be archived for later replay. Agios is recognized for its pioneering work in therapies for rare and genetically defined diseases, including a first-in-class pyruvate kinase activator for PK deficiency. The company continues to advance its clinical pipeline targeting various blood disorders.

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Agios Pharmaceuticals has announced inducement equity awards for its new Chief Financial Officer, Cecilia Jones, effective September 26, 2022. The Board of Directors approved grants including a nonstatutory option to purchase 118,390 shares at an exercise price of $27.88, along with restricted stock units for 22,417 shares and performance stock units for 10,760 shares. Vesting is contingent on continued service, with a structured timeline over four years for the options and annually for the restricted stocks. This move aligns with Nasdaq Listing Rule 5635(c)(4).

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Agios Pharmaceuticals (NASDAQ: AGIO) announced the appointment of Cecilia Jones as its new chief financial officer, effective Sept. 26, 2022. Jones replaces Jonathan Biller, who resigned to join Vertex Pharmaceuticals. With over 20 years of financial leadership experience, including her recent role at LogicBio Therapeutics, Jones is expected to enhance Agios' financial strategy amid their ongoing commercial launch of PYRUKYND and five pivotal clinical trials. The company highlights its strong financial position, aiming to maximize its impact on rare disease therapies.

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Agios Pharmaceuticals announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for PYRUKYND® (mitapivat) on September 15, 2022. This drug is aimed at treating pyruvate kinase (PK) deficiency, a rare and serious hemolytic anemia. If approved by the European Commission, it would be the first disease-modifying therapy for this condition in Europe.

The positive opinion was supported by pivotal studies demonstrating significant hemoglobin increases and reductions in transfusion burden among patients.

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Agios Pharmaceuticals (NASDAQ: AGIO) announces its participation in two September investor conferences. The company will present at the Wells Fargo Healthcare Conference on September 7, 2022, at 8:35 a.m. ET, followed by the Morgan Stanley 20th Annual Global Healthcare Conference on September 12, 2022, at 4:50 p.m. ET. Live webcasts can be accessed on Agios' website, with replays available for two weeks post-event. Agios specializes in developing therapies for rare diseases, including a first-in-class treatment for pyruvate kinase deficiency and ongoing programs in various hematological conditions.

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Agios Pharmaceuticals, Inc. (NASDAQ: AGIO) announced positive results from the pivotal Phase 3 ACTIVATE-T study of PYRUKYND® (mitapivat) for adults with pyruvate kinase (PK) deficiency, published on August 18, 2022, in The Lancet Haematology. The study demonstrated a statistically significant reduction in transfusion burden, with 37% of patients achieving a ≥33% reduction in transfusion needs. PYRUKYND is the first disease-modifying treatment approved for this condition, having received FDA approval in February 2022. The findings suggest enhanced patient quality of life and support ongoing regulatory review in Europe.

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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