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Agios Pharmaceuticals has withdrawn its European Marketing Authorization Application for TIBSOVO® (ivosidenib) in treating adult patients with relapsed or refractory acute myeloid leukemia (AML) due to insufficient clinical data supporting its benefit-risk balance. The company is advancing two Phase 3 trials of TIBSOVO® in newly diagnosed AML, which could lead to future approvals in the U.S. and EU. The company emphasizes their commitment to developing targeted treatment options for AML patients.
Agios Pharmaceuticals (NASDAQ: AGIO) has announced the final overall survival (OS) analysis from its Phase 3 ClarIDHy trial assessing TIBSOVO® (ivosidenib) in previously treated patients with IDH1-mutant cholangiocarcinoma. While a trend indicating improved OS was noted, it lacked statistical significance. Nonetheless, a significant improvement in progression-free survival (PFS) was achieved (HR 0.37, p-value < 0.0001). The company plans to file a supplemental new drug application in Q1 2021 and aims for collaboration with regulators to advance treatment options for this aggressive cancer.
Agios Pharmaceuticals, Inc. (NASDAQ: AGIO) appointed Jonathan Biller as CFO and Head of Legal and Corporate Affairs, effective September 11, 2020. He replaces Andrew Hirsch, who has served since 2016 and will assist as a strategic advisor until October 2020. Biller brings over 30 years of experience in treasury, tax, and legal sectors, having previously held significant positions at Celgene and Bunge. CEO Jackie Fouse expressed confidence in Biller's capability to drive the company's strategic vision forward.
Agios Pharmaceuticals (NASDAQ:AGIO) announced its participation in the virtual Canaccord 40th Annual Growth Conference on August 13, 2020, at 1:00 p.m. ET. The presentation will be available via live webcast under the 'Events & Presentations' section on Agios' website. A replay will be accessible for at least two weeks post-event. Agios focuses on developing innovative medicines for cancer and rare genetic diseases, boasting both approved therapies and a robust pipeline of investigational drugs. For more details, visit www.agios.com.
Agios Pharmaceuticals reported a second-quarter revenue of $37.3 million, driven by $27.6 million in net sales of TIBSOVO®, a 22% sequential increase. The company maintains its 2020 revenue guidance for TIBSOVO® at $105–115 million. Significant clinical progress includes establishing proof-of-concept for mitapivat in sickle cell disease and planning pivotal studies in thalassemia. A $255 million royalty sale extends its cash runway to support ongoing developments through 2022.
Agios Pharmaceuticals (NASDAQ: AGIO) will host a conference call and webcast on July 30, 2020, at 8:00 a.m. ET to discuss its Q2 2020 financial results and other business highlights. Investors can access the live webcast via the company's website under the 'Events & Presentations' section. Agios focuses on developing novel therapies for cancer and rare genetic diseases, boasting two approved oncology medications and a robust pipeline of investigational therapies.
Agios Pharmaceuticals (NASDAQ: AGIO) announced its participation in the BMO 2020 Prescriptions for Success Healthcare Virtual Conference on June 23, 2020, at 9:00 a.m. ET. The presentation will highlight the company's advancements in cellular metabolism treatments for cancer and rare genetic diseases. Interested parties can view a live webcast on Agios's website under the 'Events & Presentations' section, with a replay available for two weeks post-event. Agios is known for its innovative investigational medicines and precision therapies in oncology.
Agios Pharmaceuticals (NASDAQ: AGIO) has sold its tiered royalty rights on worldwide net sales of IDHIFA® to Royalty Pharma for $255 million. The agreement includes the potential for up to $55 million in regulatory milestone payments. Agios retains rights to co-promote IDHIFA® and to receive a $25 million payment upon a specified milestone. This transaction provides Agios with non-dilutive funding for its clinical pipeline, including treatments for rare diseases and AML, enhancing financial flexibility.
Agios Pharmaceuticals announces preliminary results from a Phase 1 trial of mitapivat (AG-348) for sickle cell disease, establishing clinical proof-of-concept. Of the patients, 63% achieved a hemoglobin increase of ≥1.0 g/dL, while the safety profile aligns with previous studies. The trial involved nine patients, with six completing the planned doses. The results support moving mitapivat to pivotal development, with a pivotal study targeted for next year. Adverse events were consistent with the disease context, and all data related to the pharmacodynamics of the drug were favorable.
Agios Pharmaceuticals reported positive interim results from its Phase 2 study of mitapivat for treating non-transfusion-dependent α- and β-thalassemia. The study showed that 92% of evaluable patients experienced a hemoglobin (Hb) increase of ≥1.0 g/dL, including all α-thalassemia patients. Furthermore, 88% of β-thalassemia patients achieved sustained Hb responses. Agios plans to finalize a pivotal development plan by the end of 2020 and initiate trials in 2021, positioning mitapivat as a promising treatment option in an area with limited medical advancements.
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?
