Agios Gains Breakthrough Therapy Status for Tibsovo Combo

Agios Pharmaceuticals, Inc. AGIO announced that the FDA has granted a Breakthrough Therapy designation to Tibsovo (ivosidenib) in combination with Celgene’s CELG Vidaza (azacitidine) for treating the newly diagnosed acute myeloid leukemia (AML) in adult patients with an isocitrate dehydrogenase-1(IDH-1) mutation, who are aged 75 and above and are ineligible for intensive chemotherapy.

The Breakthrough Therapy status is granted to accelerate the development and review of the drugs that target serious or life-threatening conditions.

In February 2019, Agios presented the updated data from a phase I/II study, evaluating the Tibsovo combo for the given patient population. The safety profile of the combo regime is consistent with the safety profile observed for Tibsovo and Vidaza alone in the given subjects. If approved, Agios will gain access to a broader patient population and boost sales for the promising drug.

Also, during last month, Agios announced that its supplemental new drug application (sNDA) for Tibsovo was accepted and granted a priority review by the FDA. The company is looking to get Tibsovo’s label expanded to include the first-line treatment of AML in patients with an IDH-1 mutation, who are not eligible for the standard therapy. A decision from the regulatory body is expected on Jun 21, 2019.

Shares of Agios have surged 43% so far this year, outperforming the industry’s increase of 11.7%.

Notably, last July, Tibsovo secured an FDA nod for treating adult patients suffering relapsed/refractory AML with a susceptible IDH-1 mutation. The drug is also under review in the EU for the same indication.

Tibsovo, an oral, targeted inhibitor of the IDH1 enzyme, is Agios’ first wholly owned drug. The drug generated sales of $9.4 million in the fourth quarter of 2018, reflecting a significant sequential increase.

We would like to remind investors that Agios completed its enrollment in the phase III ClarIDHy study on Tibsovo for treating the second line or later IDH-1 mutant cholangiocarcinoma in the fourth quarter of 2018. The company plans to submit an sNDA for the drug by 2019 end.

Zacks Rank & Stocks to Consider

Agios currently carries a Zacks Rank #3 (Hold). Two better-ranked stocks in the healthcare sector are Kamada Ltd. KMDA and PDL BioPharma, Inc. PDLI, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Kamada’s earnings estimates have moved 34.3% north for 2019 and 5% for 2020 over the past 60 days. The stock has risen 13% so far this year.

PDL BioPharma’s earnings estimates have been revised 92.3% upward for 2019 and 25% for 2020 over the past 60 days. The stock has rallied 27.6% in the year so far.

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