Alexion Pharmaceuticals, Inc. announced that the FDA has granted orphan drug designation (ODD) to ALXN1210, a longer-acting anti-C5 antibody that inhibits terminal complement, for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH), a debilitating, ultra-rare, life-threatening blood disorder.
Shares of Alexion have outperformed the Zacks classified Medical-Biomedical and Genetics industry in the last one year. Specifically, the stock has lost 11.1% in the past one year, while the industry witnessed a decline of 12.7%.
We note that the FDA, through its Office of Orphan Products Development, usually grants ODD to those drugs and biologics that are being developed for the safe and effective treatment, diagnosis, or prevention of rare diseases or disorders affecting less than 200,000 people in the U.S. On receiving the status, the company developing it is entitled to certain benefits and incentives, including a period of marketing exclusivity upon regulatory approval for the designated indication.
Alexion is currently evaluating ALXN1210 in phase III studies for PNH as well as for atypical hemolytic uremic syndrome (aHUS), another ultra-rare and life-threatening disease. Additionally, the company is conducting a phase I study on a new formulation of ALXN1210 when administered subcutaneously in healthy volunteers.
Meanwhile, Alexion has completed enrollment in two ongoing studies on ALXN1210 in patients with PNH – a phase I/II dose-escalating study and an open-label, multi-dose phase II study on longer dosing intervals beyond 8 weeks.
We are encouraged by the FDA granting ODD to ALXN1210. The candidate also received ODD in the EU last June for the treatment of PNH.
We note that Alexion’s key growth driver, Soliris, is approved for the treatment of both PNH and aHUS. The company is also developing Soliris for additional indications including refractory generalized myasthenia gravis and neuromyelitis optica spectrum disorder.
Alexion Pharmaceuticals, Inc. Price and Consensus
Zacks Rank & Stocks to Consider
Alexion currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in this industry include Arbutus Biopharma Corporation (ABUS - Free Report) , Epizyme, Inc. and Orexigen Therapeutics, Inc. . All the three stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Arbutus’ loss estimates narrowed 2.8% and 0.7% for 2016 and 2017, respectively, over the last 60 days. The company posted a positive surprise thrice in the four trailing quarters with an average beat of 59.31%.
Epizyme’s loss estimates narrowed 3% and 2.4% for 2016 and 2017, respectively, over the last 60 days. The company posted a positive surprise in each of the four trailing quarters, with an average beat of 14.03%. Its share price gained approximately 13% in the past one year.
Orexigen’s loss estimates for 2016 and 2017 have narrowed 8.5% and 52.4%, respectively, over the last 60 days.
Zacks' Top Investment Ideas for Long-Term Profit
How would you like to see our best recommendations to help you find today’s most promising long-term stocks? Starting now, you can look inside our portfolios featuring stocks under $10, income stocks, value investments and more. These picks, which have double and triple-digit profit potential, are rarely available to the public. But you can see them now. Click here >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
Alexion Pharmaceuticals, Inc. announced that the FDA has granted orphan drug designation (ODD) to ALXN1210, a longer-acting anti-C5 antibody that inhibits terminal complement, for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH), a debilitating, ultra-rare, life-threatening blood disorder.
Shares of Alexion have outperformed the Zacks classified Medical-Biomedical and Genetics industry in the last one year. Specifically, the stock has lost 11.1% in the past one year, while the industry witnessed a decline of 12.7%.
We note that the FDA, through its Office of Orphan Products Development, usually grants ODD to those drugs and biologics that are being developed for the safe and effective treatment, diagnosis, or prevention of rare diseases or disorders affecting less than 200,000 people in the U.S. On receiving the status, the company developing it is entitled to certain benefits and incentives, including a period of marketing exclusivity upon regulatory approval for the designated indication.
Alexion is currently evaluating ALXN1210 in phase III studies for PNH as well as for atypical hemolytic uremic syndrome (aHUS), another ultra-rare and life-threatening disease. Additionally, the company is conducting a phase I study on a new formulation of ALXN1210 when administered subcutaneously in healthy volunteers.
Meanwhile, Alexion has completed enrollment in two ongoing studies on ALXN1210 in patients with PNH – a phase I/II dose-escalating study and an open-label, multi-dose phase II study on longer dosing intervals beyond 8 weeks.
We are encouraged by the FDA granting ODD to ALXN1210. The candidate also received ODD in the EU last June for the treatment of PNH.
We note that Alexion’s key growth driver, Soliris, is approved for the treatment of both PNH and aHUS. The company is also developing Soliris for additional indications including refractory generalized myasthenia gravis and neuromyelitis optica spectrum disorder.
Alexion Pharmaceuticals, Inc. Price and Consensus
Zacks Rank & Stocks to Consider
Alexion currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in this industry include Arbutus Biopharma Corporation (ABUS - Free Report) , Epizyme, Inc. and Orexigen Therapeutics, Inc. . All the three stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Arbutus’ loss estimates narrowed 2.8% and 0.7% for 2016 and 2017, respectively, over the last 60 days. The company posted a positive surprise thrice in the four trailing quarters with an average beat of 59.31%.
Epizyme’s loss estimates narrowed 3% and 2.4% for 2016 and 2017, respectively, over the last 60 days. The company posted a positive surprise in each of the four trailing quarters, with an average beat of 14.03%. Its share price gained approximately 13% in the past one year.
Orexigen’s loss estimates for 2016 and 2017 have narrowed 8.5% and 52.4%, respectively, over the last 60 days.
Zacks' Top Investment Ideas for Long-Term Profit
How would you like to see our best recommendations to help you find today’s most promising long-term stocks? Starting now, you can look inside our portfolios featuring stocks under $10, income stocks, value investments and more. These picks, which have double and triple-digit profit potential, are rarely available to the public. But you can see them now. Click here >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
Get the latest research report on ABUS - FREE