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Agios/Celgene's Leukemia Candidate Positive in Phase I/II

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Agios Pharmaceuticals, Inc. (AGIO - Free Report) has announced positive efficacy and safety data from the ongoing phase I/II dose-escalation and expansion study on experimental candidate IDHIFA (enasidenib) at an oral session at the European Hematology Association (EHA).

IDHIFA is being developed for the treatment of patients with relapsed or refractory acute myeloid leukemia (R/R AML) and an isocitrate dehydrogenase-2 (IDH2) mutation.

We remind investors that IDHIFA is being jointly developed by Agios in collaboration with Celgene Corporation . Both companies entered into an agreement in 2010, whereby Celgene had worldwide development and commercialization rights for IDHIFA.

Agios is responsible for all clinical development activities within the IDHIFA development program and is entitled to receive a reimbursement for those development activities and up to $95 million in miletsone payments. Both the companies plan to co-commercialize IDHIFA in the U.S. Celgene will reimburse Agios for the costs incurred for its co-commercialization efforts.

Shares of Agios have outperformed the Zacks classified Medical Products industry so far this year. The stock has rallied 30.4% ahead of the broader industry’s increase of 21.6%.



The study evaluated IDHIFA in patients suffering R/R AML and an IDH2 mutation. The candidate, inhibitor of the mutant IDH2 enzyme, showed an overall response rate (ORR) of 37% (the primary endpoint of the study), including a complete response rate (CRR) of 20.1% in the study.

A maximum tolerated dose was not reached. All total, 345 patients with advanced hematologic malignances and an IDH2 mutation were enrolled into the study, of which, 281 were afflicted with R/R AML. Median duration of response was 5.6 months for all patients who responded and 8.8 months for those who achieved a CRR.

We note that the New Drug Application (NDA) for IDHIFA is currently under Priority Review in the U.S. for treating patients with R/R AML with an IDH2 mutation. The NDA has been given a Prescription Drug User Fee Act (PDUFA) action date of Aug 30.

Meanwhile, enasidenib continues to be studied in the following ongoing clinical trials: IDENTIFY (phase III/I study evaluating the efficacy and safety of enasidenib versus conventional care regimens in older patients with R/R AML with an IDH2 mutation), a phase Ib study of either enasidenib or Agio’s pipeline candidate ivosidenib (AG-120) in combination with standard induction and consolidation chemotherapy in newly diagnosed AML (NCT02632708) and a phase I/II study of either enasidenib or ivosidenib in combination with azacitidine in newly diagnosed AML (NCT02677922).

Per the company’s press release, AML is the most common form of acute leukemia. Around 21,380 adult patients suffer from AML each year in the U.S. Among the patients, only 20-25% is found to achieve a five-year survival rate after treatment. Hence, approval of the drug will allow the company to address the hugely unmet needs of patients suffering from the disease with an alternative treatment option.

Zacks Rank & Key Picks

Agios currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector are Bayer AG (BAYRY - Free Report) and Regeneron Pharmaceuticals, Inc. (REGN - Free Report) . Each stock sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings per share estimates inched up from $10.16 to $10.52 for 2017 and from $10.90 to $12.10, over the last 60 days. The company has delivered positive earnings surprises in two of the four trailing quarters with an average beat of 0.45%. Regeneron’s shares have surged 40.6% so far this year.

Bayer’s earnings per share estimates improved from $8.28 to $8.85 for 2017 and from $8.80 to $9.52 for 2018, over the last 60 days. The company has delivered positive earnings surprises in three of the four trailing quarters with an average beat of 10.25%. Shares of Bayer have jumped 31.1% so far this year.

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