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.
Agios Pharmaceuticals initiated global Phase 3 studies, ENERGIZE and ENERGIZE-T, to evaluate mitapivat for treating α- and β-thalassemia. This follows promising long-term results from a Phase 2 trial, showing sustained hemoglobin improvements and a well-tolerated safety profile over 72 weeks. The study involved 20 patients, with a mean hemoglobin increase of 1.5 g/dL at Week 60 and 1.7 g/dL at Week 72. Mitapivat is not yet approved.
An investor webcast is scheduled for Dec. 14, 2021, to discuss findings presented at the ASH Annual Meeting.
Agios Pharmaceuticals announced promising data regarding mitapivat in treating sickle cell disease, presented at the ASH Annual Meeting. The investigational drug shows potential for clinically meaningful outcomes, including improved anemia and reduced hemolysis. Key findings from studies indicate that 83.3% of trial participants achieved a significant increase in hemoglobin levels, with no serious adverse events reported. The Phase 2/3 RISE UP study has been initiated to evaluate mitapivat's efficacy and safety, alongside a virtual investor event scheduled for December 14, 2021.
Darrin Miles is set to leave Agios Pharmaceuticals (NASDAQ: AGIO) to pursue a Chief Executive Officer position at a private biotechnology company. Effective Dec. 6, 2021, Richa Poddar has been appointed as the new Chief Commercial Officer. Poddar has a strong background at Agios, contributing significantly to the oncology portfolio and preparing for the launch of mitapivat for pyruvate kinase deficiency. Agios is focused on developing innovative treatments for genetically defined diseases, with mitapivat being a key player in their pipeline.
Agios Pharmaceuticals (NASDAQ: AGIO) announced promising long-term safety and efficacy results for mitapivat in treating chronic hemolytic anemias like PK deficiency and thalassemia. Data from two investigator-sponsored studies supports advancing mitapivat for sickle cell disease. AG-946, a new candidate, showed dose-dependent efficacy in ATP and 2,3-DPG changes in a Phase 1 trial. Agios will present eight abstracts at the ASH Annual Meeting from Dec. 11-14, 2021, highlighting their advancements in these therapies. An investor webcast is scheduled for Dec. 14, 2021.
Agios Pharmaceuticals (AGIO) received FDA Priority Review for mitapivat, targeting adults with PK deficiency, with a PDUFA date of Feb. 17, 2022. The company has initiated Phase 3 ENERGIZE and ENERGIZE-T studies in thalassemia and plans to host an investor day on Nov. 17 to share pipeline updates. In Q3 2021, Agios reported a net loss of $88.8 million but improved its cash position to $1.4 billion, enabling future operations without additional equity raises. R&D expenses rose to $64 million, driven by new clinical trials.
Agios Pharmaceuticals (NASDAQ: AGIO) will hold a conference call on November 3, 2021, at 8:00 a.m. ET to discuss its third quarter 2021 financial results. The call will be accessible by phone and via a live webcast on Agios' website. The company is focused on developing medicines for genetically defined diseases, with its lead candidate, mitapivat, being evaluated for three distinct hemolytic anemias. A replay of the event will be available shortly after the conclusion.
Agios Pharmaceuticals (NASDAQ: AGIO) announced its participation in two upcoming investor conferences. The Citi’s 16th Annual Biopharma Virtual Conference will feature a panel on Sickle Cell and related conditions on September 10 at 12:30 p.m. ET. Additionally, the 2021 Cantor Virtual Global Healthcare Conference is scheduled for September 27 at 8:00 a.m. ET. Live webcasts will be available on their website, with replays accessible for at least two weeks post-event. Agios focuses on innovative treatments for genetically defined diseases, with its leading drug candidate, mitapivat, targeting hemolytic anemias.
Agios Pharmaceuticals announced on August 17, 2021, that the FDA has accepted its New Drug Application (NDA) for mitapivat, aimed at treating adults with pyruvate kinase deficiency. This NDA received a Priority Review designation, expediting the review process to a PDUFA date of February 17, 2022. Mitapivat is being positioned as a potential first disease-modifying therapy for this chronic condition, with the FDA’s designation indicating significant improvements in treatment.
Agios Pharmaceuticals (AGIO) recently completed regulatory submissions for mitapivat, targeting adults with Pyruvate Kinase deficiency in the U.S. and EU. The company presented positive Phase 3 study results for mitapivat at the EHA Virtual Congress, showing strong efficacy, including an 80% hemoglobin increase in thalassemia patients. Q2 2021 R&D expenses rose to $62 million, while net loss decreased to $86.2 million. Agios reported $1.7 billion in cash reserves, sufficient for ongoing operations and future developments, including two planned Phase 3 trials and a Phase 2/3 trial in sickle cell disease.
Agios Pharmaceuticals (NASDAQ: AGIO) has scheduled a conference call for July 29, 2021, at 8:00 a.m. ET to discuss its second quarter 2021 financial results and business highlights. The call will be accessible via telephone or live webcast through the company’s website. Agios specializes in developing medicines for genetically defined diseases, with its lead drug candidate, mitapivat, targeting hemolytic anemias.
FAQ
What is the current stock price of Agios Pharmaceuticals (AGIO)?
What is the market cap of Agios Pharmaceuticals (AGIO)?
What does Agios Pharmaceuticals specialize in?
What are some recent achievements of Agios Pharmaceuticals?
What is the financial status of Agios Pharmaceuticals?
What is mitapivat?
What is the significance of the ENERGIZE-T study results?
How does Agios support diversity in clinical trials?
What are some key upcoming milestones for Agios in 2024?
What strategic partnerships does Agios have?
What is Agios' approach to ESG?
How can I stay updated on Agios Pharmaceuticals?
