【what is bugsplat】Agios' (AGIO) Phase III Study on Mitapivat Meets Primary Goal

Agios Pharmaceuticals,what is bugsplat Inc.

(AGIO) announced that the phase III ACTIVATE study, which evaluated its first-in-class pyruvate kinase-R activator, mitapivat, for treating pyruvate kinase (“PK”) deficiency in patients who do not receive regular blood transfusions, has met the primary endpoint.

Data from the study shows that treatment with mitapivat led to a statistically significant, sustained increase in hemoglobin level in 40% of patients compared to none in the placebo arm. Importantly, the safety profile of mitapivat was similar to that seen in previously published study data.

Shares of Agios have lost 2.5% so far this year against the industry’s increase of 1.6%.

price chart for AGIO

We note that mitapivat is one of the key pipeline candidates of Agios, which is being developed for treating patients with PK deficiency. The candidate is also being evaluated in the single-arm ACTIVATE-T study for addressing PK in patients who receive regular blood transfusions with top-line results from the same expected in the first quarter of 2021.

Agios plans to submit regulatory filing for mitapivat to address adult patients with PK deficiency in the United States and Europe in 2021. Upon potential approval, the company plans to launch mitapivat in 2022 in both the United States and Europe.

Meanwhile, Agios is also developing mitapivat for treating sickle cell disease (“SCD”), a blood disorder, and thalassemia.

In November 2020, the FDA granted an orphan drug designation to mitapivat for the treatment of patients suffering from SCD. The company plans to begin a pivotal phase III study on mitapivat for SCD in 2021.

In June 2020, mitapivat was also granted an orphan drug status from the FDA for addressing patients with thalassemia. A phase III study evaluating mitapivat for the given indication is expected to commence in 2021.

Zacks Rank & Stocks to Consider

Agios currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the same sector include

Owens & Minor, Inc.

OMI,

LeMaitre Vascular, Inc.

LMAT and

InMode Ltd.

INMD, all sporting a Zacks Rank #1 (Strong Buy) at present. You can see

the complete list of today’s Zacks #1 Rank stocks here

.

Owens & Minor’s earnings estimates have been revised 3.2% upward for 2020 and 5.3% for 2021 over the past 60 days. The stock has skyrocketed 399.8% year to date.

LeMaitre Vascular’s earnings estimates have been revised 29.8% upward for 2020 and 16.8% for 2021 over the past 60 days. The stock has inched up 4.3% year to date.

Story continues

InMode’s earnings estimates have been revised 37.9% upward for 2020 and 24.5% for 2021 over the past 60 days. The stock has rallied 14.3% year to date.

Zacks Names “Single Best Pick to Double”

From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research SherazMian hand-picks one to have the most explosive upside of all.

You know this company from its past glory days, but few would expect that it’s poised for a monster turnaround. Fresh from a successful repositioning and flush with A-list celeb endorsements, it could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in a little more than 9 months and Nvidia which boomed +175.9% in one year.

Free: See Our Top Stock and 4 Runners Up >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days.

Click to get this free report

Owens & Minor, Inc. (OMI) : Free Stock Analysis Report

LeMaitre Vascular, Inc. (LMAT) : Free Stock Analysis Report

Agios Pharmaceuticals, Inc. (AGIO) : Free Stock Analysis Report

InMode Ltd. (INMD) : Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research

View comments

很赞哦!（1）