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Alexion Pharmaceuticals Inc (ALXN.O)

ALXN.O on Nasdaq

122.59USD
30 Nov 2016
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Latest Key Developments (Source: Significant Developments)

Alexion gets orphan drug designation for ALXN1007
Monday, 29 Aug 2016 04:33pm EDT 

Alexion Pharmaceuticals Inc : European Commission grants orphan drug designation to ALXN1007 for the treatment of patients with graft-versus-host disease (GVHD) .ALXN1007 is currently being evaluated in a phase 2 study in patients with newly diagnosed acute GI-GVHD.  Full Article

Alexion Pharmaceuticals-FDA recently completed routine current good manufacturing practice inspection of Co's Smithfield, Rhode Island Manufacturing Facility
Monday, 8 Aug 2016 04:41pm EDT 

Alexion Pharmaceuticals Inc : Fda recently completed routine current good manufacturing practice inspection of Co's Smithfield, Rhode island manufacturing facility . FDA observations also pertain to monitoring of water systems . Based on current information, alexion anticipates that supply of soliris to patients will not be interrupted . FDA observations pertain to completion, closure of certain investigations, validation of surface sampling methods .Based on current information, does not anticipate material financial impact to resolve outstanding fda concerns.  Full Article

Alexion reports Q2 non-gaap EPS $1.13
Thursday, 28 Jul 2016 06:30am EDT 

Alexion Pharmaceuticals Inc : Sees FY non gaap earnings per share $4.50 to $4.65 . Sees FY non gaap total revenues $3,050 to $3,100 million . FY2016 earnings per share view $5.05, revenue view $3.06 billion -- Thomson Reuters I/B/E/S . Alexion reports second quarter 2016 results . Q2 non-gaap earnings per share $1.13 . Q2 gaap earnings per share $0.51 . Q2 revenue $753 million versus I/B/E/S view $742.7 million . Q2 earnings per share view $1.17 -- Thomson Reuters I/B/E/S . Sees FY gaap earnings per share $1.91 to $2.26 .Sees FY gaap total revenues $3,050 to $3,100 million.  Full Article

Alexion Pharmaceuticals announces data from phase 1/2 study of ALXN1210
Friday, 10 Jun 2016 02:30am EDT 

Alexion Pharmaceuticals Inc : 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 . Once-Monthly dosing of ALXN1210 achieved rapid and sustained reductions in mean levels of lactate dehydrogenase . Says no serious adverse events or study withdrawals were observed in either patient cohort . 2 patients experienced serious treatment-related adverse events and one patient had a grade 2 infusion-related reaction . Says six deaths were reported, none of which were considered related to treatment with ALXN1007 . Says were no grade 3 or higher non-serious adverse events related to treatment with ALXN1007 .Says one patient withdrew from study due to a treatment-emergent adverse event.  Full Article

Alexion announces topline results from Phase 3 regain study of eculizumab
Monday, 6 Jun 2016 04:01pm EDT 

Alexion Pharmaceuticals Inc : Alexion announces topline results from Phase 3 regain study of eculizumab (soliris) in patients with refractory generalized myasthenia gravis (GMG) . Primary endpoint of regain study missed statistical significance . Alexion continues to analyze data from regain study .Four patients receiving eculizumab (6.5 pct) discontinued treatment due to an adverse event.  Full Article

Alexion Pharmaceuticals says EC grants orphan drug designation to ALXN1210
Wednesday, 1 Jun 2016 04:05pm EDT 

Alexion Pharmaceuticals Inc :European Commission has granted orphan drug designation to ALXN1210.  Full Article

Alexion Pharmaceuticals Inc gives FY 2016 guidance
Wednesday, 3 Feb 2016 06:31am EST 

Alexion Pharmaceuticals Inc:Expects FY 2016 constant currency total product revenues of $3.170 to $3.220 billion.Expects FY 2016 constant currency earnings per share of $5.31 to $5.51.  Full Article

Alexion Pharmaceuticals Inc says NEJM publishes pivotal phase 3 data on Kanuma in children and adults with lysosomal acid lipase deficiency
Wednesday, 9 Sep 2015 05:00pm EDT 

Alexion Pharmaceuticals Inc:Says NEJM publishes pivotal phase 3 data on Kanuma in children and adults with lysosomal acid lipase deficiency.In the study, Kanuma met the primary endpoint of alanine aminotransferase normalization compared with placebo as well as six secondary endpoints.  Full Article

Alexion Pharmaceuticals Inc raises FY 2015 revenue guidance and lowers FY 2015 EPS guidance
Thursday, 30 Jul 2015 06:30am EDT 

Alexion Pharmaceuticals Inc:Raises FY 2015 revenue from the previous range of $2.55 to $2.6 billion to the higher and narrower range of $2.6 to $2.62 billion.Revises FY 2015 non-GAAP EPS guidance to the range of $4.70-$4.80 per share from the previous range of $5.60 to $5.80 per share.FY 2015 revenue of $2.63 billion and EPS of $4.98 - Thomson Reuters I/B/E/S.  Full Article

Alexion Pharmaceuticals Inc's Strensiq receives marketing approval in Japan
Monday, 6 Jul 2015 06:00am EDT 

Alexion Pharmaceuticals Inc:Says Japan's Ministry of Health, Labour and Welfare approves the Co's New Drug Applicatio for the use of Strensiq as a treatment for patients in Japan with hypophosphatasia (HPP).Expects that initial patients with HPP in Japan will start commercial treatment with Strensiq by late Q3 2015.  Full Article

BRIEF-Alexion Pharmaceuticals announces new data

* Alexion Pharmaceuticals Inc - new data from an analysis of patients enrolled in global atypical hemolytic uremic syndrome (aHUS) registry