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Agios Rides on Tibsovo Approval Amid Reliance on Celgene

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On Oct 16, we issued an updated research report on Agios Pharmaceuticals, Inc. (AGIO - Free Report) . The company’s top line mainly consists of milestone payments and collaboration revenues on the net sales of Idhifa, which is owned by its partner Celgene Corporation (CELG - Free Report) . Its wholly owned product Tibsovo was approved by the FDA in July 2018 and holds immense commercial potential in the acute myeloid leukemia (AML) market.

Although Tibsovo did not contribute to Agios’ revenues in the second quarter, it is likely to boost the company’s top line in the future quarters.

Tibsovo, an isocitrate dehydrogenase-1 (IDH1) inhibitor, is indicated for treating relapsed or refractory (R/R AML) with a susceptible IDH1 mutation. The candidate was approved a month before the expected action date. A regulatory filing for the candidate in the EU is expected during the fourth quarter of 2018 for the same indication.

Tibsovo is also being evaluated in a phase I study for treating advanced hematologic malignancies and in a phase I/II combination study with Celgene’s Vidaza for attending newly diagnosed AML patients, who are not eligible for an intensive chemotherapy.

Pipeline Promises Potential

Agios’ lead rare genetic diseases candidate, AG-348, is under evaluation in a phase II program on adult, transfusion-independent patients with Pyruvate kinase (PK) deficiency. In June, the company announced the initiation of the phase III ACTIVATE analysis on the candidate for treating adult patients with PK deficiency, who do not undergo regular blood transfusions.

AG-348 is also being evaluated in a phase III program called ACTIVATE-T, a single-arm pivotal study on adult PK deficiency patients, who receive regular blood transfusions. The company also plans to begin a phase II proof of concept evaluation in the fourth quarter of 2018 on AG-348 for addressing thalassemia.

Agios is conducting phase I programs on AG-881 for treating patients with advanced IDH1 or IDH2 mutant-positive solid tumors including glioma.

The company plans to submit an investigational new drug (IND) application for AG-636, an inhibitor of the metabolic enzyme dihydroorotate dehydrogenase (DHODH) for treating hematologic malignancies during the fourth quarter.

However, Agios’ heavy dependence on partner Celgene for reaping revenues is a persistent concern. Stiff competition is another headwind for the company as several other industry players like AstraZeneca (AZN - Free Report) , Merck (MRK - Free Report) , Eli Lilly and Roche have their candidates lined up for treating cancer and rare genetic metabolic disorders by targeting cellular metabolism.

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