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Alexion's BLA for ALXN1210 Gets Priority Review From FDA
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Alexion Pharmaceuticals, Inc. announced that the FDA has granted a priority review to its biologics license application (BLA) for C5 complement inhibitor, ALXN1210, pertaining to the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH). The FDA has set an action date of Feb 18, 2019.
Alexion used a rare disease priority review voucher, which should expedite the review within eight months instead of the standard 12 months. Priority Review designation from the FDA is generally granted to drugs with potential to provide significant improvements in the safety and effectiveness of the treatment plus prevention or diagnosis of a serious disease.
The application is supported by positive data from two rigorous phase III studies on the largest population of patients with PNH ever evaluated. The trial included enrollees, who had never received a complement inhibitor and also those who were stable on Alexion’s lead drug Soliris and even switched to ALXN1210.
Data from the studies showed that patients with PNH can be effectively and safely shifted from treatment with Soliris every two weeks to treatment with ALXN1210, every eight weeks.
If approved, ALXN1210 will be the first and the only long-acting complement inhibitor for patients with PNH, which will ensure a complete inhibition of the C5 complement protein sustained over an eight-week dosing regimen.
Alexion has submitted a Marketing Authorization Application to the European Medicines Agency for ALXN1210 regarding the given indication. The candidate received an orphan drug designation in the United States as well as in the EU.
Shares of Alexion have lost 2.9% year to date, narrower than the industry’s decrease of 6.6%.
We would like to remind investors that Alexion’s blockbuster drug Soliris is already approved for the treatment of patients with PNH in the United States, EU and Japan. The drug is a top revenue driver for the company. Soliris generated $898.2 million of revenues in the second quarter of 2018, driven by strong volume growth.
Gilead Sciences’ earnings estimates have been moved 7.7% north for 2018 and 2.2% for 2019 over the past 60 days. The stock has inched up 1% year to date.
Ligand’s earnings estimates have been revised 14.4% upward for 2018 and 3.7% for 2019 over the past 60 days. The stock has soared 74.9% so far this year.
Illumina’s earnings estimates have been raised 11.1% for 2018 and 8.7% for 2019 over the past 60 days. The stock has surged 49.2% so far this year.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
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Alexion's BLA for ALXN1210 Gets Priority Review From FDA
Alexion Pharmaceuticals, Inc. announced that the FDA has granted a priority review to its biologics license application (BLA) for C5 complement inhibitor, ALXN1210, pertaining to the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH). The FDA has set an action date of Feb 18, 2019.
Alexion used a rare disease priority review voucher, which should expedite the review within eight months instead of the standard 12 months. Priority Review designation from the FDA is generally granted to drugs with potential to provide significant improvements in the safety and effectiveness of the treatment plus prevention or diagnosis of a serious disease.
The application is supported by positive data from two rigorous phase III studies on the largest population of patients with PNH ever evaluated. The trial included enrollees, who had never received a complement inhibitor and also those who were stable on Alexion’s lead drug Soliris and even switched to ALXN1210.
Data from the studies showed that patients with PNH can be effectively and safely shifted from treatment with Soliris every two weeks to treatment with ALXN1210, every eight weeks.
If approved, ALXN1210 will be the first and the only long-acting complement inhibitor for patients with PNH, which will ensure a complete inhibition of the C5 complement protein sustained over an eight-week dosing regimen.
Alexion has submitted a Marketing Authorization Application to the European Medicines Agency for ALXN1210 regarding the given indication. The candidate received an orphan drug designation in the United States as well as in the EU.
Shares of Alexion have lost 2.9% year to date, narrower than the industry’s decrease of 6.6%.
We would like to remind investors that Alexion’s blockbuster drug Soliris is already approved for the treatment of patients with PNH in the United States, EU and Japan. The drug is a top revenue driver for the company. Soliris generated $898.2 million of revenues in the second quarter of 2018, driven by strong volume growth.
Alexion Pharmaceuticals, Inc. Price and Consensus
Alexion Pharmaceuticals, Inc. Price and Consensus | Alexion Pharmaceuticals, Inc. Quote
Zacks Rank
Alexion carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Gilead Sciences, Inc. (GILD - Free Report) , Ligand Pharmaceuticals Inc., (LGND - Free Report) and Illumina, Inc. (ILMN - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Gilead Sciences’ earnings estimates have been moved 7.7% north for 2018 and 2.2% for 2019 over the past 60 days. The stock has inched up 1% year to date.
Ligand’s earnings estimates have been revised 14.4% upward for 2018 and 3.7% for 2019 over the past 60 days. The stock has soared 74.9% so far this year.
Illumina’s earnings estimates have been raised 11.1% for 2018 and 8.7% for 2019 over the past 60 days. The stock has surged 49.2% so far this year.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>