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Agios (AGIO) Secures FDA Approval for Leukemia Drug Tibsovo
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Agios Pharmaceuticals, Inc (AGIO - Free Report) announced that the FDA has approved its leukemia drug Tibsovo (ivosidenib) for treating adult patients suffering from relapsed/refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH-1) mutation.
Tibsovo, an oral, targeted inhibitor of the IDH1 enzyme, is the first and the only FDA-approved therapy for patients with R/R AML and an IDH1 mutation.
Notably, last December, Agios submitted a new drug application (NDA) to the FDA for Tibsovo (ivosidenib). Subsequently, in February this year, the FDA accepted the NDA under priority review for the given indication and assigned an action date of Aug 21, 2018. However, the approval came almost a month earlier than expected.
A regulatory filing for the drug in the EU is expected during the fourth quarter of 2018 for the same indication.
The FDA nod comes on the back of encouraging data from a phase I study for front-line AML patients with an IDH1 or IDH2 mutant-positive. Data from the trial showed that Tibsovo has potential to deliver strong, durable responses as a single agent and can also help patients achieve and maintain transfusion independence.
Tibsovo is the second IDHm inhibitor approved in less than a year for the company. Agios’ first IDHm inhibitor and its only marketed drug Idhifa was approved by the FDA last August for the treatment of patients with relapsed or refractory AML and an IDH2 mutation.
The approval comes as a huge boost to the company’s growth and for AML affected patients with IDH1 mutation, persistently waiting for new treatment options other than a conventional chemotherapy. The drug was approved simultaneously with Abbott’s (ABT - Free Report) RealTime IDH1 companion diagnostic test for detecting patients with R/R AML.
We remind investors that Agios is also conducting a phase I/II trial in combination with Celgene's Vidaza for the treatment of newly diagnosed AML patients, not eligible for intensive chemotherapy. Also, ivosidenib is being evaluated in phase I study for the therapy of advanced hematologic malignancies
Shares of Agios have soared 59.3% year to date, outperforming the industry’s increase of 10.3%.
Eagle Pharmaceuticals’ earnings estimates have been revised 14.2% upward for 2018 and 25% for 2019 over the past 60 days. The stock has surged 56.1% so far this year.
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Agios (AGIO) Secures FDA Approval for Leukemia Drug Tibsovo
Agios Pharmaceuticals, Inc (AGIO - Free Report) announced that the FDA has approved its leukemia drug Tibsovo (ivosidenib) for treating adult patients suffering from relapsed/refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH-1) mutation.
Tibsovo, an oral, targeted inhibitor of the IDH1 enzyme, is the first and the only FDA-approved therapy for patients with R/R AML and an IDH1 mutation.
Notably, last December, Agios submitted a new drug application (NDA) to the FDA for Tibsovo (ivosidenib). Subsequently, in February this year, the FDA accepted the NDA under priority review for the given indication and assigned an action date of Aug 21, 2018. However, the approval came almost a month earlier than expected.
A regulatory filing for the drug in the EU is expected during the fourth quarter of 2018 for the same indication.
The FDA nod comes on the back of encouraging data from a phase I study for front-line AML patients with an IDH1 or IDH2 mutant-positive. Data from the trial showed that Tibsovo has potential to deliver strong, durable responses as a single agent and can also help patients achieve and maintain transfusion independence.
Tibsovo is the second IDHm inhibitor approved in less than a year for the company. Agios’ first IDHm inhibitor and its only marketed drug Idhifa was approved by the FDA last August for the treatment of patients with relapsed or refractory AML and an IDH2 mutation.
The approval comes as a huge boost to the company’s growth and for AML affected patients with IDH1 mutation, persistently waiting for new treatment options other than a conventional chemotherapy. The drug was approved simultaneously with Abbott’s (ABT - Free Report) RealTime IDH1 companion diagnostic test for detecting patients with R/R AML.
We remind investors that Agios is also conducting a phase I/II trial in combination with Celgene's Vidaza for the treatment of newly diagnosed AML patients, not eligible for intensive chemotherapy. Also, ivosidenib is being evaluated in phase I study for the therapy of advanced hematologic malignancies
Shares of Agios have soared 59.3% year to date, outperforming the industry’s increase of 10.3%.
Agios currently carries a Zacks Rank #3 (Hold). Another better-ranked stock in the same sector is Eagle Pharmaceuticals, Inc. (EGRX - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here
Eagle Pharmaceuticals’ earnings estimates have been revised 14.2% upward for 2018 and 25% for 2019 over the past 60 days. The stock has surged 56.1% so far this year.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
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