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Alnylam (ALNY) Gets Positive CHMP Opinion for Lumasiran

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Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of its RNAi candidate, lumasiran, targeting the hydroxyacid oxidase 1 (HAO1) mRNA — encoding glycolate oxidase (GO) — in development for the treatment of primary hyperoxaluria type 1 (PH1). The ultra-rare disease causes a progressive decline in kidney function and can lead to end-stage renal disease. Lumasiran will be marketed in Europe under the brand name Oxlumo. A decision by the European Commission is expected in the fourth quarter of 2020.

Shares of Alnylam have gained 26.3% year to date against the industry’s decline of 0.2%.

The positive opinion is supported by the efficacy and safety findings of Oxlumo in PH1 patients, including data from both ILLUMINATE-A and ILLUMINATE-B phase III studies. Key primary and secondary endpoints included the reduction of urinary and plasma oxalate and the proportion of patients achieving normalization or near-normalization of urinary oxalate in response to Oxlumocomparedto placebo. 

The candidate also enjoys the Priority Medicines (PRIME) designation by the EMA andthe Orphan Drug designation in the European Union.Alnylam filed a new drug application (NDA) with the FDA. The FDA has granted a Priority Review for the NDA and set an action date of Dec 3, 2020.

Meanwhile, the company is also evaluating several other candidates. A few significant ones include vutrisiran andinclisiran. The company and partner Novartis’ (NVS - Free Report) inclisiranis under review in the United States and Europe for treating heterozygous familial hypercholesterolemia and atherosclerotic cardiovascular disease.

Alnylam has a collaboration with Regeneron Pharmaceuticals (REGN - Free Report) to discover, develop and commercialize new RNAi therapeutics for a broad range of diseases by addressing disease targets expressed in the liver, eye and central nervous system.

Zacks Rank and Stock to Consider

Alnylam currently carries a Zacks Rank #3 (Hold).

A better-ranked stock in the healthcare sector includes Emergent Biosolutions Inc. (EBS - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Emergent’s earnings estimates have increased from $4.23 to $6.61 for 2020 and from $5.55 to $8.42 for 2021 over the past 90 days. Shares of the company have increased 83.2% year to date.


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