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, 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.
Agios Pharmaceuticals (NASDAQ: AGIO) announced that the FDA granted orphan drug designation to mitapivat, their first-in-class pyruvate kinase-R (PKR) activator, for treating thalassemia. This designation supports the development of therapies for rare diseases affecting fewer than 200,000 U.S. patients. Agios plans to share updated Phase 2 study data at the upcoming European Hematology Association Annual Congress. Mitapivat targets non-transfusion-dependent β- and α-thalassemia and is also being studied for sickle cell disease. The drug remains investigational and is not yet FDA-approved.
Agios Pharmaceuticals has announced that clinical data for mitapivat and ivosidenib will be presented at the European Hematology Association (EHA) Annual Congress from June 11-14, 2020. Key presentations include interim results from a phase 2 study of mitapivat for non-transfusion-dependent thalassemia and results showing ivosidenib improves survival in mutant IDH1 acute myeloid leukemia (AML). A virtual investor event will also be held on June 12, 2020, to discuss these findings.
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