FDA Grants Agios' (AGIO) Leukemia Candidate Priority Review

Agios Pharmaceuticals, Inc. AGIO announced that the FDA accepted the company’s new drug application (“NDA”) for its isocitrate dehydrogenase 1 (IDH1) mutant inhibitor ivosidenib (AG-120). The company is seeking to get ivosidenib approved for the treatment of patients with relapsed or refractory (R/R) acute myeloid leukemia (“AML”) with an IDH1 mutation. The FDA granted priority review to the candidate and set an action date of Aug 21, 2018.

Year to date, Agios’ share price improved 58.2%, compared with the industry’s gain of 16.8%.

 

 

Priority Review designation from the FDA is generally granted to drugs that have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease. 

Ivosidenib is being evaluated in a phase I expansion cohort for treatment of patients with IDH1m R/R AML. Data from the study demonstrated durable responses in patients with the given indication. This enabled the company to submit a NDA to the FDA for ivosidenib in December 2017.

In addition to the NDA, a premarket approval application was also submitted to the FDA by Abbott Laboratories ABT for the FDA review of an IDH1 assay on the Abbott m2000 RealTime System. The assay automatically prepares samples and analyzes batches for nucleic acid amplification and detection. IDH1 mutations occur in about 6% to 10% of AML patients. The Abbott assay will serve as a companion diagnostic for ivosidenib.

Ivosidenib is also being evaluated in phase I study for treatment of advanced hematologic malignancies and phase I/II combination with Celgene’s CELG Vidaza for treatment of newly diagnosed AML patients, who are not eligible for intensive chemotherapy.

The potential approval of the candidate will boost sales for the company.

 

Agios Pharmaceuticals, Inc. Price

 

Agios Pharmaceuticals, Inc. Price | Agios Pharmaceuticals, Inc. Quote

 

Zacks Rank & Stock to Consider

Agios is a Zacks Rank #3 (Hold) stock.

A better-ranked stock from the health care space is XOMA Corp XOMA carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

XOMA’s loss per share estimates have narrowed from 99 cents to 42 cents for 2018 in the last 60 days. The company pulled off a positive earnings surprise in one of the last four quarters, with an average beat of 47.92%. Share price of the company skyrocketed 416.1% over a year.

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