Agios Pharmaceuticals, Inc. AGIO announced that its supplemental new drug application (sNDA) for its leukemia drug Tibsovo (ivosidenib) has been 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 acute myeloid leukemia (AML) in patients with an isocitrate dehydrogenase 1 (IDH1) mutation, who are not eligible for standard therapy.
Last July, Tibsovo gained 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.
With the receipt of a priority review from the FDA, a decision is expected on Jun 21, 2019. This review status will accelerate the assessment time of the sNDA from 10 to a span of six months.
The sNDA submission was based on data from the phase I dose-escalation and expansion study on Tibsovo, evaluating the newly diagnosed AML patients, who are not eligible for standard treatment such as intensive and non-intensive chemotherapy. If approved, it will help Agios gain access to a broader patient population and boost sales for this promising drug.
Shares of Agios have declined 26.4% in the past year against the industry’s increase of 7.3%.
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.
Tibsovo is also being evaluated in combination with Celgene’s CELG Vidaza for treating newly diagnosed AML patients, who are ineligible for intensive chemotherapy. Agios plans to conclude enrollment in the study by 2020.
Notably, Agios completed enrollment in the phase III ClarIDHy study on Tibsovo for the treatment of second line or later IDH1 mutant cholangiocarcinoma in the fourth quarter of 2018. The company plans to submit an sNDA for the same by this year-end.
Zacks Rank & Stocks to Consider
Agios currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include BioDelivery Sciences International, Inc. BDSI and ProQR Therapeutics N.V. PRQR, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
BioDelivery Sciences’ loss per share estimates have been narrowed 12% for 2019 over the past 60 days. The stock has soared 132.2% in the past year.
ProQR Therapeutics’ loss per share estimates have been narrowed 5.9% for 2019 over the past 60 days. The stock has skyrocketed 268.7% in the past year.
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