On Aug 14, we issued an updated research report on Agios Pharmaceuticals, Inc. (AGIO - Free Report) .
The company’s top line mainly consists of product revenues from the sale of its newly launched precision medicine Tibsovo (ivosidenib) and royalties plus milestone payments related to the sales of Idhifa, which is owned by its partner Celgene Corporation (CELG - Free Report) .
Tibsovo was approved by the FDA last July for treating adult patients suffering relapsed or refractory acute myeloid leukemia (AML) with IDH-1 mutation. The drug is currently under review in the EU for the same indication.
Tibsovo generated sales of $13.7 million in the second quarter of 2019, reflecting a sequential surge of more than 50%.
Meanwhile, several label expansion studies on Tibsovo are currently underway. In May, the FDA approved the supplemental new drug application (sNDA) for Tibsovo in the first-line setting. The nod came much earlier than the expected date of Jun 21.
Also, in May, Tibsovo met the primary endpoint in a late-stage study, which evaluated it for the previously treated IDH1 mutant cholangiocarcinoma also called bile-duct cancer. Agios plans to file an 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. On approval, it can fuel sales growth for the drug.
In March, Agios achieved another goal when the FDA granted a Breakthrough Therapy designation to Tibsovo in combination with Celgene’s Vidaza for treating the newly diagnosed AML in adult patients with an IDH-1 mutation, who are aged 75 and above and are ineligible for intensive chemotherapy.
Apart from Tibsovo, Agios has several interesting candidates in its portfolio that are in early to mid-stage development targeting various cancers and other indications.
Agios’ key pipeline candidate mitapivat is being developed to treat patients with (PK) deficiency. The company plans to close enrollment in two pivotal studies on mitapivat by 2019 end.
Agios plans to begin a registration-enabling phase III study on another candidate vorasidenib for treating low-grade glioma with an IDH1 mutation by this year-end. Moreover, the company initiated dosing in the phase I dose-escalation study on AG-636 for treating advanced lymphoma in the second quarter of 2019.
Notably, AG-270 is being developed for the treatment of cancers carrying methylthioadenosine phosphorylase (MTAP)-deleted tumors.
Although Agios is riding high with the success of Tibsovo of late and its pipeline candidates showing great progressing well, the company’s heavy dependence on partner Celgene for royalty revenues remains a woe. Stiff competition from pharma giants is another headwind for the company as several other leading industry players like AstraZeneca (AZN - Free Report) , Eli Lilly (LLY - Free Report) , AbbVie and Roche have their candidates lined up for treating cancer and rare genetic metabolic disorders by targeting cellular metabolism.
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