Alnylam (ALNY) Gets Positive CHMP Opinion for Lumasiran
Alnylam Pharmaceuticals, Inc. ALNY 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 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 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, 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.
Alnylam Pharmaceuticals, Inc. Price
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