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Alexion Presents Data from Ultra-Rare Blood Disorder Study
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Alexion Pharmaceuticals, Inc. announced encouraging results from an ongoing open-label, 24-week, dose-escalation phase I/II study on ALXN1210 in patients suffering from paroxysmal nocturnal hemoglobinuria (PNH), an ultra-rare blood disorder. Data were presented at the annual meeting of the American Society of Hematology.
Alexion’s year-to-date share price movement shows that the stock has underperformed the Zacks classified Medical-Biomedical/Genetics industry. The stock has lost a significant 35.5% year-to-date in comparison to a drop of 25.6% for the industry. However, it reacted favorably to Trump’s victory. In fact, Alexion saw a 3% increase in its share price, compared to the 2.8% for the industry, following the election results.
Interim analysis of 13 patients showed that rapid and sustained reductions in lactate dehydrogenase (a direct marker of hemolysis – the destruction of red blood cells) in all the patients when treated with once-monthly dosing were observed at the first evaluable time point (week 1). Moreover, these benefits were sustained over the study analysis period of up to 24 weeks.
In addition, patients experienced improvements in the Functional Assessment of Chronic Illness Therapy-Fatigue score from baseline with those in the higher-dose cohort achieving a two-fold improvement compared with those in the lower-dose cohort. On the safety front, no serious adverse events or withdrawals from the study were observed.
Alexion is currently enrolling patients with PNH and atypical hemolytic uremic syndrome (aHUS) in phase III studies to evaluate ALXN1210, administered every eight weeks. The company is also conducting a phase I study to evaluate a new formulation of the candidate, administered subcutaneously, in healthy volunteers.
Meanwhile, Alexion has completed enrollment in an open-label, multi-dose phase II study on ALXN1210, which is evaluating longer dosing intervals beyond eight weeks.
We note that ALXN1210 is a longer-acting C5 antibody that inhibits terminal complement. The candidate received Orphan Drug designation from the European Commission for the treatment of patients with PNH this June.
Alexion’s key growth driver, Soliris, is also approved for the treatment of PNH and aHUS. Additionally, the company is developing Soliris for several other indications such as generalized myasthenia gravis and delayed kidney transplant graft function.
Alexion currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Sucampo Pharmaceuticals, Inc. , Vanda Pharmaceuticals, Inc. (VNDA - Free Report) and Anika Therapeutics Inc. (ANIK - Free Report) . 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.
Sucampo’s earnings estimates increased from $1.03 to $1.22 for 2016 and from $1.30 to $1.58 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 35.55%.
Vanda’s loss estimates narrowed from 68 cents to 52 cents for 2016, while its earnings estimates increased from 16 cents to 22 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged almost 68% year to date.
Anika’s earnings estimates increased from $1.96 to $2.06 for 2016 and from $2.03 to $2.09 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 33.14%. Its share price has gained approximately 22% year to date.
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Alexion Presents Data from Ultra-Rare Blood Disorder Study
Alexion Pharmaceuticals, Inc. announced encouraging results from an ongoing open-label, 24-week, dose-escalation phase I/II study on ALXN1210 in patients suffering from paroxysmal nocturnal hemoglobinuria (PNH), an ultra-rare blood disorder. Data were presented at the annual meeting of the American Society of Hematology.
Alexion’s year-to-date share price movement shows that the stock has underperformed the Zacks classified Medical-Biomedical/Genetics industry. The stock has lost a significant 35.5% year-to-date in comparison to a drop of 25.6% for the industry. However, it reacted favorably to Trump’s victory. In fact, Alexion saw a 3% increase in its share price, compared to the 2.8% for the industry, following the election results.
Interim analysis of 13 patients showed that rapid and sustained reductions in lactate dehydrogenase (a direct marker of hemolysis – the destruction of red blood cells) in all the patients when treated with once-monthly dosing were observed at the first evaluable time point (week 1). Moreover, these benefits were sustained over the study analysis period of up to 24 weeks.
In addition, patients experienced improvements in the Functional Assessment of Chronic Illness Therapy-Fatigue score from baseline with those in the higher-dose cohort achieving a two-fold improvement compared with those in the lower-dose cohort. On the safety front, no serious adverse events or withdrawals from the study were observed.
Alexion is currently enrolling patients with PNH and atypical hemolytic uremic syndrome (aHUS) in phase III studies to evaluate ALXN1210, administered every eight weeks. The company is also conducting a phase I study to evaluate a new formulation of the candidate, administered subcutaneously, in healthy volunteers.
Meanwhile, Alexion has completed enrollment in an open-label, multi-dose phase II study on ALXN1210, which is evaluating longer dosing intervals beyond eight weeks.
We note that ALXN1210 is a longer-acting C5 antibody that inhibits terminal complement. The candidate received Orphan Drug designation from the European Commission for the treatment of patients with PNH this June.
Alexion’s key growth driver, Soliris, is also approved for the treatment of PNH and aHUS. Additionally, the company is developing Soliris for several other indications such as generalized myasthenia gravis and delayed kidney transplant graft function.
ALEXION PHARMA Price
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Zacks Rank & Key Picks
Alexion currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Sucampo Pharmaceuticals, Inc. , Vanda Pharmaceuticals, Inc. (VNDA - Free Report) and Anika Therapeutics Inc. (ANIK - Free Report) . 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.
Sucampo’s earnings estimates increased from $1.03 to $1.22 for 2016 and from $1.30 to $1.58 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 35.55%.
Vanda’s loss estimates narrowed from 68 cents to 52 cents for 2016, while its earnings estimates increased from 16 cents to 22 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged almost 68% year to date.
Anika’s earnings estimates increased from $1.96 to $2.06 for 2016 and from $2.03 to $2.09 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 33.14%. Its share price has gained approximately 22% year to date.
The Best Place to Start Your Stock Search
Today, you are invited to download the full list of 220 Zacks Rank #1 "Strong Buy" stocks – absolutely free of charge. Since 1988, Zacks Rank #1 stocks have nearly tripled the market, with average gains of +26% per year. Plus, you can access the list of portfolio-killing Zacks Rank #5 "Strong Sells" and other private research. See these stocks free >>