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Alexion (ALXN) Gains On Positive Date From Lead Candidate
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Shares of Alexion Pharmaceuticals, Inc. gained 3.38% after the company reported positive data on candidate, ALXN1210 from a pivotal phase III study.
Alexion’s shares have declined 11.7% in the last six months, worse than the industry’s loss of 8.8%.
This phase III randomized, open-label, active-controlled, multinational, and multicenter study evaluated the efficacy and safety of ALXN1210 compared to Alexion’s lead drug Soliris administered by intravenous (IV) infusion to adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who are naïve to complement inhibitor treatment.
The study was designed to evaluate the non-inferiority of ALXN1210 compared to Soliris. ALXN1210 demonstrated non-inferiority to Soliris in complement inhibitor treatment-naïve patients with PNH based on the co-primary endpoints of transfusion avoidance and normalization of lactate dehydrogenase (“LDH”) levels.
In addition, the study also demonstrated non-inferiority on all four key secondary endpoints — percentage change from baseline in LDH levels, change from baseline in quality of life as assessed by the Functional Assessment of Chronic Illness Therapy (“FACIT”) — Fatigue scale, proportion of patients with breakthrough hemolysis, and proportion of patients with stabilized hemoglobin levels.
ALXN1210 was well tolerated with a safety profile that is consistent with that seen for Soliris. The candidate was then evaluated for superiority testing as non-inferiority was achieved across both co-primary and all four key secondary endpoints. While ALXN1210 did not achieve superiority, a numeric trend in favor of ALXN1210 was observed for breakthrough hemolysis for Soliris with a p-value of 0.074. The data also showed that ALXN1210 provides immediate and complete inhibition of the complement C5 protein that is sustained over the entire 8 week dosing interval.
The positive results should support ALXN1210 as the new standard of care for patients with PNH. Alexion plans to submit ALXN1210 in PNH in the United States, EU, and Japan in the second half of 2018.
In addition to PNH, ALXN1210 is also being evaluated for atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive myasthenia gravis (MG). ALXN210 is also being evaluated in a phase III study in complement inhibitor-naïve patients with aHUS, administered intravenously every eight weeks.
The company also plans to initiate a single, pharmacokinetics-based phase III study of ALXN1210 delivered subcutaneously once per week as a potential treatment for patients with PNH and aHUS. Alexion also plans to initiate the development of ALXN1210 as a potential treatment for patients with generalized MG (gMG) and patients with immunoglobulin A nephropathy (IgAN).
The candidate has also received Orphan Drug Designation (for the treatment of patients with PNH in the United States and EU, and for the subcutaneous treatment of patients with aHUS in the United States.
Alexion’s blockbuster drug, Soliris, continues to perform well and the FDA approval of the drug for generalized myasthenia gravis will further boost sales. However, the company relies heavily on Soliris for growth and sales of Soliris will be impacted by ramp of ALXN1210 trials.
The successful development and commercialization of ALXN1210 will reduce the company’s dependence on Soliris and extend the patent of the PNH franchise as well.
Regeneron’s earnings per share estimates have moved up from $18.65 to $18.68 for 2018 and 2019 respectively in the last 30 days. The company pulled off a positive earnings surprise in three of the last four quarters, with an average beat of 9.15%.
Ligand’s earnings per share estimates have moved up $3.78 to $4.20 from $4.75 to $5.32 for 2018 and 2019, respectively over the last 30 days. The company delivered positive earnings surprises in three of the trailing four quarters, with an average beat of 24.88%.
Enanta Pharma delivered a positive earnings surprise in three of the last four quarters, with an average beat of 373.1%. The company’s shares surged 193.6% over a 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 (ALXN) Gains On Positive Date From Lead Candidate
Shares of Alexion Pharmaceuticals, Inc. gained 3.38% after the company reported positive data on candidate, ALXN1210 from a pivotal phase III study.
Alexion’s shares have declined 11.7% in the last six months, worse than the industry’s loss of 8.8%.
This phase III randomized, open-label, active-controlled, multinational, and multicenter study evaluated the efficacy and safety of ALXN1210 compared to Alexion’s lead drug Soliris administered by intravenous (IV) infusion to adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who are naïve to complement inhibitor treatment.
The study was designed to evaluate the non-inferiority of ALXN1210 compared to Soliris. ALXN1210 demonstrated non-inferiority to Soliris in complement inhibitor treatment-naïve patients with PNH based on the co-primary endpoints of transfusion avoidance and normalization of lactate dehydrogenase (“LDH”) levels.
In addition, the study also demonstrated non-inferiority on all four key secondary endpoints — percentage change from baseline in LDH levels, change from baseline in quality of life as assessed by the Functional Assessment of Chronic Illness Therapy (“FACIT”) — Fatigue scale, proportion of patients with breakthrough hemolysis, and proportion of patients with stabilized hemoglobin levels.
ALXN1210 was well tolerated with a safety profile that is consistent with that seen for Soliris. The candidate was then evaluated for superiority testing as non-inferiority was achieved across both co-primary and all four key secondary endpoints. While ALXN1210 did not achieve superiority, a numeric trend in favor of ALXN1210 was observed for breakthrough hemolysis for Soliris with a p-value of 0.074. The data also showed that ALXN1210 provides immediate and complete inhibition of the complement C5 protein that is sustained over the entire 8 week dosing interval.
The positive results should support ALXN1210 as the new standard of care for patients with PNH. Alexion plans to submit ALXN1210 in PNH in the United States, EU, and Japan in the second half of 2018.
In addition to PNH, ALXN1210 is also being evaluated for atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive myasthenia gravis (MG). ALXN210 is also being evaluated in a phase III study in complement inhibitor-naïve patients with aHUS, administered intravenously every eight weeks.
The company also plans to initiate a single, pharmacokinetics-based phase III study of ALXN1210 delivered subcutaneously once per week as a potential treatment for patients with PNH and aHUS. Alexion also plans to initiate the development of ALXN1210 as a potential treatment for patients with generalized MG (gMG) and patients with immunoglobulin A nephropathy (IgAN).
The candidate has also received Orphan Drug Designation (for the treatment of patients with PNH in the United States and EU, and for the subcutaneous treatment of patients with aHUS in the United States.
Alexion’s blockbuster drug, Soliris, continues to perform well and the FDA approval of the drug for generalized myasthenia gravis will further boost sales. However, the company relies heavily on Soliris for growth and sales of Soliris will be impacted by ramp of ALXN1210 trials.
The successful development and commercialization of ALXN1210 will reduce the company’s dependence on Soliris and extend the patent of the PNH franchise as well.
Zacks Rank & Key picks
Alexion currently carries a Zacks Rank #4 (Sell).
A few better-ranked stocks from the same space are Regeneron Pharmaceuticals (REGN - Free Report) Ligand Pharmaceuticals (LGND - Free Report) and Enanta Pharma (ENTA - Free Report) . While Regeneron sports a Zacks Rank #1 (Strong Buy), Ligand and Enanta Pharma carry a Zacks Rank #2 (Buy), each. You can see the complete list of today’s Zacks #1 Rank stocks here.
Regeneron’s earnings per share estimates have moved up from $18.65 to $18.68 for 2018 and 2019 respectively in the last 30 days. The company pulled off a positive earnings surprise in three of the last four quarters, with an average beat of 9.15%.
Ligand’s earnings per share estimates have moved up $3.78 to $4.20 from $4.75 to $5.32 for 2018 and 2019, respectively over the last 30 days. The company delivered positive earnings surprises in three of the trailing four quarters, with an average beat of 24.88%.
Enanta Pharma delivered a positive earnings surprise in three of the last four quarters, with an average beat of 373.1%. The company’s shares surged 193.6% over a 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 >>