Agios Pharmaceuticals Inc Stock Price, News & Analysis

Agios Pharmaceuticals has withdrawn its European Marketing Authorization Application for TIBSOVO® (ivosidenib) in treating adult patients with relapsed or refractory acute myeloid leukemia (AML)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.