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Alnylam (ALNY) Files for Oxlumo Label Expansion in US & EU
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Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced that it has submitted a supplemental new drug application (sNDA) to the FDA and a Type II filing variation to the European Medicines Agency (EMA) for its RNAi therapeutic, lumasiran for the reduction of plasma oxalate in the treatment of patients with advanced primary hyperoxaluria type 1 (PH1).
The latest label expansion filings submitted to the FDA and EMA were based on positive data from the phase III ILLUMINATE-C study, which evaluated lumasiran in patients of all ages with advanced PH1. Data from the same showed that treatment with lumasiran led to substantial reductions in plasma oxalate in PH1 patients with end-stage kidney disease, including those on hemodialysis.
Please note that the FDA had approved lumasiran under the trade name Oxlumo for the treatment of PH1 to lower urinary oxalate levels in pediatric and adult patients in November 2020. During the same time the European Commission (EC) granted marketing authorization to Oxlumo for the treatment of PH1 in all age groups.
Shares of Alnylam have rallied 42.9% so far this year against the industry’s decline of 21.6%.
Image Source: Zacks Investment Research
Oxlumo injection recorded global net product revenues of about $15 million in the third quarter of 2021, reflecting a decrease of 9% sequentially.
Successful development and a potential label expansion of Oxlumo in the additional indication should drive sales in the future quarters.
We remind investors that apart from Oxlumo, Alnylam markets Onpattro, which is approved for the treatment of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. The company’s second product, Givlaari, is approved for the treatment of acute hepatic porphyria both in the United States and Europe.
In June 2021, the FDA accepted Alnylam’s new drug application (“NDA”) for another investigational RNAi therapeutic, vutrisiran, being developed for the treatment of adult patients with polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. A decision from the regulatory body is expected on Apr 14, 2022.
Vutrisiran is also under review in Europe for the same indication.
Image: Bigstock
Alnylam (ALNY) Files for Oxlumo Label Expansion in US & EU
Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced that it has submitted a supplemental new drug application (sNDA) to the FDA and a Type II filing variation to the European Medicines Agency (EMA) for its RNAi therapeutic, lumasiran for the reduction of plasma oxalate in the treatment of patients with advanced primary hyperoxaluria type 1 (PH1).
The latest label expansion filings submitted to the FDA and EMA were based on positive data from the phase III ILLUMINATE-C study, which evaluated lumasiran in patients of all ages with advanced PH1. Data from the same showed that treatment with lumasiran led to substantial reductions in plasma oxalate in PH1 patients with end-stage kidney disease, including those on hemodialysis.
Please note that the FDA had approved lumasiran under the trade name Oxlumo for the treatment of PH1 to lower urinary oxalate levels in pediatric and adult patients in November 2020. During the same time the European Commission (EC) granted marketing authorization to Oxlumo for the treatment of PH1 in all age groups.
Shares of Alnylam have rallied 42.9% so far this year against the industry’s decline of 21.6%.
Oxlumo injection recorded global net product revenues of about $15 million in the third quarter of 2021, reflecting a decrease of 9% sequentially.
Successful development and a potential label expansion of Oxlumo in the additional indication should drive sales in the future quarters.
We remind investors that apart from Oxlumo, Alnylam markets Onpattro, which is approved for the treatment of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. The company’s second product, Givlaari, is approved for the treatment of acute hepatic porphyria both in the United States and Europe.
In June 2021, the FDA accepted Alnylam’s new drug application (“NDA”) for another investigational RNAi therapeutic, vutrisiran, being developed for the treatment of adult patients with polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. A decision from the regulatory body is expected on Apr 14, 2022.
Vutrisiran is also under review in Europe for the same indication.
Zacks Rank & Stocks to Consider
Alnylam currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Sarepta Therapeutics, Inc. (SRPT - Free Report) , Editas Medicine, Inc. (EDIT - Free Report) and vTv Therapeutics Inc. (VTVT - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for Sarepta Therapeutics have narrowed 28.2% for 2021 and 24.5% for 2022 over the past 60 days.
Earnings of Sarepta Therapeutics surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions.
Loss per share estimates for Editas Medicine have narrowed 11.2% for 2021 and 4.6% for 2022 over the past 60 days.
Editas Medicine’s earnings surpassed estimates in two of the trailing four quarters and missed the same on two occasions.
Loss per share estimates for vTv Therapeutics have narrowed 21.7% for 2021 and 2.9% for 2022 over the past 60 days.
vTv Therapeutics’ earnings surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.