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Agios' Tibsovo Meets Endpoint in Cholangiocarcinoma Study

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Agios Pharmaceuticals, Inc. AGIO announced that its leukemia drug Tibsovo (ivosidenib) met the primary endpoint in a late-stage study, which evaluated it for the previously treated IDH1 mutant cholangiocarcinoma, also called bile-duct cancer.

The phase III ClarIDHy program on Tibsovo demonstrated a statistically significant improvement in progression-free survival (PFS) compared with patients, who received placebo. Agios plans to file a supplemental new drug application (sNDA) to the FDA for including the above indication in Tibsovo’s label by this year-end. Notably, no treatment options are currently available for this disease.

Shares of Agios rallied 18.8% in after-hours trading following the news on Wednesday. In fact, the stock has risen 6% so far this year, outperforming the industry’s increase of 5.4%.

The company plans to present full results from the study at the European Society for Medical Oncology Congress in Barcelona later this year.

Notably, in the fourth quarter of 2018, Agios completed enrollment in the phase III ClarIDHy study on Tibsovo for the given patient population.

Tibsovo — an oral, targeted inhibitor of the IDH1 enzyme — is Agios’ first wholly owned marketed drug, which got an FDA approval last July for treating adult patients suffering relapsed/refractory acute myeloid leukemia (AML) with a susceptible IDH-1 mutation. The drug is also under review in the EU for the same indication.

Earlier this month, the FDA approved Agios’ NDA, looking for an approval of Tibsovo in the first-line setting. Tibsovo, as a monotherapy, won the nod for the first-line treatment of IDH1 mutant adult AML patients, who are not eligible for intensive induction chemotherapy. The approval came much earlier than the expected date of Jun 21, 2019.

Meanwhile, in March, Agios achieved another goal when the regulatory agency granted a Breakthrough Therapy designation to Tibsovo, for its use in combination with Celgene’s CELG Vidaza to treat the newly diagnosed AML in adult patients with an IDH-1 mutation, who are aged 75 and above and are ineligible for an intensive chemotherapy.

Tibsovo generated sales of $9.1 million in the first quarter of 2019, which reflected a sequential decrease. The drug’s label expansion studies look encouraging and subsequent approvals should drive its sales in the future quarters.

Zacks Rank & Stocks to Consider

Agios currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Merus N.V. MRUS and Gilead Sciences, Inc. GILD, both flaunting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Merus’ loss per share estimates have been narrowed 28% for 2019 and 30.7% for 2020 over the past 60 days.

Gilead’s earnings estimates have moved 3.8% north for 2019 and 1.6% for 2020 over the past 60 days. The stock has gained 4.4% year to date.

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