Agios (AGIO) Withdraws Filing for Leukemia Drug Tibsovo in EU

Agios Pharmaceuticals, Inc. AGIO announced that it has withdrawn the marketing authorization application (MAA) for Tibsovo, which is FDA-approved to address adult patients with relapsed/refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) mutation.

The company decided to withdraw the European filing based on an unfavorable feedback from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency’s (EMA). The opinion suggested that the single arm phase I study based on which Tibsovo was filed for the given indication did not sufficiently support a positive benefit-risk balance.

Shares of Agios have declined 24.9% so far this year against the industry’s increase of 0.9%.

Tibsovo was approved for the treatment of relapsed/refractory AML with a susceptible IDH1 mutation by the FDA in July 2018. The drug generated sales worth $50.2 million in the first six months of 2020. In the current year, the company expects Tibsovo sales in the range of $105-$115 million

Meanwhile, in May 2019, Tibsovo was approved by the FDA in the first-line setting. This nod was crucial as it expanded the drug’s eligible patient population and should drive sales higher in the future quarters too.

Several label expansion studies on Tibsovo are currently underway. The drug is being evaluated in combination with Celgene’s wholly owned subsidiary of Bristol-Myers’ BMY Vidaza for treating newly diagnosed AML patients who are ineligible for intensive chemotherapy in the phase III AGILE study. Agios plans to conclude enrollment in the study by 2021.

Additionally, the phase III HOVON150/AMLSG29 study is investigating Tibsovo or Celgene’s Idhifa (enasidenib) in combination with the standard induction and consolidation chemotherapy for treating newly diagnosed AML patients who are eligible for intensive chemotherapy.

In May 2019, Tibsovo met the primary endpoint in the phase III ClarIDHy study in previously-treated patients with IDH1 mutant cholangiocarcinoma, also called bile-duct cancer. In September 2020, the company reported final overall survival data from the above-mentioned study. A consistent trend in improved OS was noticed in patients treated with Tibsovo versus placebo but was not statistically significant. Agios expects to file an sNDA for the above indication in the first quarter of 2021.

If successfully developed for the above additional indications, Agios plans to get Tibsovo approved both in the United States and Europe for the same.

Zacks Rank & Stocks to Consider

Agios currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include Quidel Corporation QDEL and Owens Minor, Inc. OMI, both sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Quidel’s earnings estimates have been revised 23.9% upward for 2020 and 46.2% for 2021 over the past 60 days. The stock has skyrocketed 240.2% year to date.

Owens Minor’s earnings estimates have been revised 66.4% upward for 2020 and 50% for 2021 over the past 60 days. The stock has rallied 400.2% year to date.

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