Alexion Pharmaceuticals Inc (ALXN.O) Key Developments | Reuters.com
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Alexion Pharmaceuticals Inc (ALXN.O)

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Latest Key Developments (Source: Significant Developments)

Alexion Pharmaceuticals Inc announces new data from first natural history study in juveniles with hypophosphatasia (hpp) showing substantial disease burden
Saturday, 7 Mar 2015 03:22pm EST 

Alexion Pharmaceuticals Inc:Announced that researchers presented new data from a retrospective, multinational natural history study of children (symptom onset ≥6 months to <18 years) with hypophosphatasia (HPP).In this study, which included 32 patients with juvenile-onset HPP, children with HPP had substantial disease burden, particularly with regard to musculoskeletal abnormalities and growth deficiencies.Children from this cohort experienced HPP-related skeletal problems, other disease complications and morbidity that persisted despite standard efforts to control symptoms.  Full Article

Alexion Pharmaceuticals Inc reaffirms FY 2015 guidance - Conference Call
Monday, 2 Mar 2015 03:30pm EST 

Alexion Pharmaceuticals Inc:Says FY 2015 financial guidance includes revenue of $2.55 billion to $2.6 billion and EPS guidance is at $5.60 to $5.80 per share.  Full Article

FDA grants priority review for Alexion Pharmaceuticals's Asfotase Alfa as a treatment for patients with Hypophosphatasia
Monday, 2 Mar 2015 06:30am EST 

Alexion Pharmaceuticals Inc:Says the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Company's Biologics License Application (BLA) for asfotase alfa, an investigational, first-in-class enzyme replacement therapy for treatment of patients with infantile- and juvenile-onset hypophosphatasia (HPP).BLA submission is supported by data from 71 treated patients with HPP enrolled in three prospective studies and their extensions, as well as two retrospective natural history studies.  Full Article

Alexion Pharmaceuticals appoints CEO
Thursday, 29 Jan 2015 06:30am EST 

Alexion Pharmaceuticals Inc:Appointed David L. Hallal as the Chief Executive Officer (CEO), effective April 1.Hallal currently serves as Alexion's Chief Operating Officer (COO) and is a Director of the Board. He will succeed Leonard Bell, M.D., Chairman and CEO, who will retire as CEO and continue to serve as Chairman of the Board.  Full Article

Alexion Pharmaceuticals Inc gives FY 2015 outlook below analysts' estimates
Thursday, 29 Jan 2015 06:27am EST 

Alexion Pharmaceuticals Inc:Expects FY 2015 worldwide net product sales are to be within a range of $2.55 to $2.6 billion.FY 2015 non-GAAP earnings per share to be $5.60 to $5.80.FY 2015 revenue of $2.73 billion, EPS of $5.91 - Thomson Reuters I/B/E/S.  Full Article

Alexion Pharmaceuticals Inc reaffirms FY 2014 guidance - Conference Call
Monday, 12 Jan 2015 01:30pm EST 

Alexion Pharmaceuticals Inc:Says financial guidance for FY 2014 remains unchanged with revenue growing at 38 pct and non-GAAP EPS growing at 56 pct.FY 2014 EPS of $5.20 - Thomson Reuters I/B/E/S.  Full Article

Alexion Pharmaceuticals Inc completes rolling BLA submission to U.S. FDA for Asfotase Alfa as treatment for patients with Hypophosphatasia
Tuesday, 30 Dec 2014 06:30am EST 

Alexion Pharmaceuticals Inc:Says completion of rolling submission of Biologics License Application (BLA) to U.S. (FDA) for asfotase alfa, an investigational, first-in-class enzyme replacement therapy for the treatment of hypophosphatasia (HPP).Says HPP is genetic, chronic and progressive ultra-rare metabolic disease that can lead to destruction and deformity of bones, profound muscle weakness, seizures, respiratory failure and premature death (1-5).  Full Article

Alexion Pharmaceuticals Inc announces $500 mln share repurchase program
Monday, 15 Dec 2014 06:30am EST 

Alexion Pharmaceuticals Inc:Says new share repurchase program of up to $500 mln.New share repurchase program will take effect upon completion of company's current program, which has about $22 mln remaining of its previously authorized $400 mln.  Full Article

Alexion Pharmaceuticals Inc's Soliris (eculizumab) Granted Orphan Drug Designation in Japan
Wednesday, 10 Dec 2014 04:15pm EST 

Alexion Pharmaceuticals Inc:Says that Soliris(eculizumab) has been granted orphan drug designation (ODD) by Japan's Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with myasthenia gravis (MG), a rare, debilitating neurologic disorder.In patients with MG, uncontrolled complement activation due to antibodies directed at the neuromuscular junction can ultimately lead to profound and debilitating weakness of various muscle groups throughout the body.This significant muscle weakness can impair patients' ability to walk, speak clearly, swallow and, in some cases, to breathe.  Full Article

Alexion Pharmaceuticals's Soliris receives orphan drug designation by Japan's Ministry of Health, Labour and Welfare
Tuesday, 25 Nov 2014 06:30am EST 

Alexion Pharmaceuticals Inc:Says it has been granted orphan drug designation by Japan's Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with neuromyelitis optica, a life-threatening, ultra-rare neurologic disorder.In patients with NMO, chronic, uncontrolled complement activation results in severe damage to the central nervous system (CNS), predominantly impacting the optic nerve and spinal cord.  Full Article

BRIEF-Alexion Pharmaceuticals announces data from phase 1/2 study of ALXN1210

* Late-Breaking data presented at EHA: all patients with pnh treated with once-monthly dosing of ALXN1210 in phase 1/2 study exhibit rapid and sustained reductions in ldhSays announced today that interim data were presented from a phase 1/2 study of ALXN1210