Agios Pharmaceuticals Inc Stock Price, News & Analysis

Agios Pharmaceuticals announced a transformative strategic shift, focusing on its genetically defined disease portfolio, particularly mitapivat, a potential treatment for hemolytic anemias. The company is selling its oncology portfolio to Servier for up to $2.0 billion, comprising $1.8 billion upfront and $200 million in potential milestone payments. Post-transaction, Agios intends to return at least $1.2 billion to shareholders. The deal aims to bolster Agios' capital and advance its future treatments while enhancing Servier's oncology capabilities.

Agios Pharmaceuticals (NASDAQ: AGIO) announced positive results from the Phase 1 trial of mitapivat for sickle cell disease. The study demonstrated that 55% of patients achieved a hemoglobin increase of ≥1.0 g/dL, with a mean increase of 1.3 g/dL overall. The safety profile was consistent with previous studies, showing mostly Grade 1-2 adverse events. Based on these promising results, Agios plans to initiate a Pivotal Program for mitapivat in 2021. The company will discuss these findings in an investor webcast on December 8, 2020.

Agios Pharmaceuticals announced that its Phase 3 ACTIVATE trial of mitapivat for PK deficiency achieved its primary endpoint, with 40% of patients experiencing a significant hemoglobin increase of ≥1.5 g/dL, compared to none in the placebo group (p<0.0001). The safety profile aligns with prior data, and no adverse events led to discontinuation. Agios plans to seek regulatory approval in the U.S. and EU in 2021, with a potential launch in 2022. Topline results from the ACTIVATE-T trial are expected in Q1 2021.

Agios Pharmaceuticals (NASDAQ:AGIO) announced the launch of Anemia ID, a no-cost genetic testing program for patients with suspected hereditary anemias. This initiative aims to provide comprehensive diagnostic testing using a next-generation sequencing panel that explores over 50 genetic mutations linked to various anemia disorders. The program seeks to facilitate accurate diagnoses, thereby improving disease management and treatment options for patients. The testing is conducted by PerkinElmer Genomics, and all costs are covered by Agios.

Agios Pharmaceuticals (NASDAQ:AGIO) is set to present at the Piper Sandler 32nd Annual Virtual Healthcare Conference on December 2, 2020, at 2:00 p.m. ET. This event highlights Agios' commitment to advancing treatments in cancer and rare genetic diseases through its focus on cellular metabolism.

A live webcast will be available in the Investors section of the Agios website, with an archived replay accessible for two weeks post-presentation.

Agios Pharmaceuticals (NASDAQ: AGIO) announced that the FDA granted orphan drug designation to its PKR activator, mitapivat, for treating sickle cell disease. This designation highlights the significant unmet needs of this patient group. Mitapivat is an investigational oral drug aimed to enhance red blood cell energy and longevity by improving PKR enzyme activity. The company plans to initiate a Phase 3 study in 2021. Orphan drug designation provides benefits like market exclusivity upon approval, reduced FDA fees, and tax credits for clinical trials.

Agios Pharmaceuticals reported a net revenue of $31.7 million for TIBSOVO® in Q3 2020, a 15% increase from the previous quarter. Total revenue reached $34.7 million, up 33% year-over-year, supported by an 82% rise in TIBSOVO® sales. The company narrowed its 2020 revenue guidance for TIBSOVO® to $113–115 million. Upcoming milestones include topline data from the ACTIVATE trial by year-end and a supplemental new drug application for TIBSOVO® in Q1 2021. However, they withdrew the European Marketing Authorization Application for TIBSOVO® in AML following feedback from the EMA.

Agios Pharmaceuticals will host a virtual investor event on December 8, 2020, at 8:00 a.m. ET to discuss key clinical findings presented at the American Society of Hematology (ASH) Annual Meeting from December 5-8, 2020.

Eight abstracts from Agios and three from collaborators will be showcased, focusing on their oncology and rare genetic diseases programs. Notable presentations include findings on Ivosidenib and various studies related to Pyruvate Kinase Deficiency. For further details, the event will be webcast live on their website.

Agios Pharmaceuticals will host a webinar on November 19, 2020, from 8:00 a.m. to 10:30 a.m. ET, focusing on its pyruvate kinase-R (PKR) activation clinical programs and commercial outlook for hemolytic anemias. The event will feature presentations from Agios leadership and experts discussing PKR's role in treating disorders such as pyruvate kinase deficiency, thalassemia, and sickle cell disease. Attendees can access the live webcast through the Agios website, with a replay available for two weeks post-event.