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Alnylam (ALNY) Ends Enrollment in Advanced Hyperoxaluria Study

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Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced that it has achieved full patient enrollment in its ILLUMINATE-C phase III study of its RNAi candidate, Oxlumo (lumasiran), targeting the hydroxyacid oxidase 1 (HAO1) the gene encoding glycolate oxidase (GO) — for the treatment of adults and children with advanced primary hyperoxaluria type 1 (PH1). The ultra-rare disease causes a progressive decline in kidney function and can lead to end-stage renal disease.

Shares of Alnylam have gained 13.9% year to date compared with the industry’s growth of 4.6%.

ILLUMINATE-C (NCT04152200) is a single arm, open-label, multinational phase III study to evaluate the safety and efficacy of lumasiran in PH1 patients of all ages and advanced PH1 including those experiencing systemic oxalosis and undergoing hemodialysis. The primary endpoint of the study is the percent change in plasma oxalate from baseline to month 6. Key secondary endpoints are designed to evaluate additional measures of plasma oxalate and changes in urinary oxalate, and quality of life assessments. The company expects to report top-line results from the study in mid-2021.

The company believes that lumasiran has the potential to address the full spectrum of PH1 disease severity.

We remind investors that, in November 2020, the FDA approved Oxlumo injection for subcutaneous use, the first-ever therapy available for the treatment of PH1 to lower urinary oxalate levels in pediatric and adult patients. It is the first RNai therapeutic approved in the United States for use in both children and adults,.. In the same month,the European Commission (EC) granted marketing authorization for Oxlumo for the treatment PH1 in all age groups.

Zacks Rank & Stocks to Consider

Alnylam currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the healthcare sector include Aerpio Pharmaceuticals Ltd. , Aptose Biosciences Inc. (APTO - Free Report) and Alimera Sciences Inc. (ALIM - Free Report) . All of them carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Aerpio’s loss per share estimates have narrowed from 15 cents to 14 cents for 2020 and from 63 cents to 57 cents for 2021 over the past 60 days.

Aptose’s loss per share estimates have narrowed from 77 cents to 69 cents for 2020 and from 85 cents to 81 cents for 2021 over the past 60 days.

Alimera’s loss per share estimates have narrowed from $1.31 to 96 cents for 2020 over the past 60 days.

 

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