Agios (AGIO) Surges More Than 40% Year to Date: Here's Why
Last July, the FDA approved Agios’ first wholly owned precision medicine, Tibsovo (ivosidenib), for treating adult patients with relapsed or refractory acute myeloid leukemia (AML) having an isocitrate dehydrogenase-1 (IDH-1) mutation.
The drug generated sales of $9.4 million in the fourth quarter of 2018, reflecting a significant sequential increase.
Tibsovo is currently under review in the EU for the same indication. On approval, it can fuel sales growth in the future.
Meanwhile, several label expansion studies on Tibsovo are currently underway. Notably, last month, Agios announced that its supplemental new drug application (sNDA) for Tibsovo was accepted and granted a priority review by the FDA. With the sNDA filing, the company is looking to get Tibsovo’s label expanded to include the first-line treatment of AML in patients with IDH1 mutation, who are not eligible for the standard therapy. A decision from the regulatory body is awaited on Jun 21, 2019.
If the company gets a nod in the first-line setting, it will be eligible to treat a broader AML patient population, which can drive Tibsovo’s sales higher.
Meanwhile, Tibsovo is also being evaluated in combination with Celgene’s CELG Vidaza (azacitidine) for treating the newly diagnosed AML patients with IDH-1 mutation, who are 75 year-old and above and are ineligible for an intensive chemotherapy. This week, Agios announced that the FDA has granted a Breakthrough Therapy designation to this combination therapy.
We would like to remind investors that 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 drug by 2019 end.
All these label expansion studies are progressing well so far. We believe, Tibsovo’s target market — AML patients with IDH-1 mutation —has an immense commercial potential. However, any kind of hostile development or a regulatory setback for Tibsovo could hurt the company’s growth prospects and weigh heavily on the stock.
Agios Pharmaceuticals, Inc. Price
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 rallied 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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