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News Breaks
August 25, 2014
07:52 EDTALXNAlexion says Soliris production not interrupted by FDA facility inspection
From August 18 through August 22, the U.S. Food and Drug Administration inspected Alexion's Smithfield, Rhode Island manufacturing facility. As previously disclosed, Alexion had earlier received an FDA Warning Letter, dated March 22, 2013, regarding compliance with current Good Manufacturing Practices at the Rhode Island facility. At the conclusion of the August inspection, the FDA issued a Form 483 with three inspectional observations, none of which was designated as a repeat observation to the March 22, 2013 Warning Letter. These observations are inspectional, and do not represent a final FDA determination of compliance. The three observations include a need for enhanced training around gowning procedures, more frequent environmental monitoring, and processes related to identification of the definitive root cause of a prior bioburden excursion. Addressing FDA observations and advancing quality initiatives has been a key priority for Alexion and the company has enhanced and expects to continually enhance its overall quality program. The company will continue to work diligently to address the observations identified in the Form 483. Alexion continues to manufacture products, including Soliris in this facility. Based on current information, Alexion believes that the supply of Soliris to patients will not be interrupted. Based on current information, Alexion does not believe there will be any material financial impact to address the observations and resolve outstanding FDA concerns. Unless and until Alexion is able to correct outstanding issues to the FDAs satisfaction, the FDA may withhold approval of requests for export certificates for certain countries
News For ALXN From The Last 14 Days
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February 5, 2016
09:26 EDTALXNLeerink biotech analyst holds an analyst/industry conference call
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06:02 EDTALXNAlexion resumed with an Outperform at Leerink
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February 4, 2016
07:40 EDTALXNAlexion guidance conservative, says Oppenheimer
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07:32 EDTALXNAlexion shares should be bought aggressively, says SunTrust
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07:26 EDTALXNAlexion weakness a buying opportunity, says Brean Capital
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February 3, 2016
09:19 EDTALXNOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Boot Barn (BOOT), up 20.7%... Oclaro (OCLR), up 8.2%... Edwards Lifesciences (EW), up 5.8%... Natural Health (NHTC), up 5.7%... Viavi Solutions (VIAV), up 2.8%. ALSO HIGHER: Conatus (CNAT), up 18.8% after the FDA has granted Fast Track designation to the company's emricasan development program for the treatment of liver cirrhosis... Marvell Technology (MRVL), up 3.3% after Starboard Value disclosed a 6.7% activist stake in the company... Syngenta (SYT), up 2.9% after ChemChina offers to acquire the company in a transaction valued over $43B. DOWN AFTER EARNINGS: Navios Maritime Partners (NMM), down 33.5%... National-Oilwell Varco (NOV), down 7.9%... Chipotle (CMG), down 5.7%... Yahoo (YHOO), down 1.9%... Mondelez (MDLZ), down 4.4%... Illumina (ILMN), down 4.6%... Alexion Pharmaceuticals (ALXN), down 3.5%... Merck (MRK), down fractionally.
06:36 EDTALXNAlexion reports Q4 non-GAAP EPS $1.13, consensus $1.10
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06:33 EDTALXNAlexion sees FY16 EPS $5.00-$5.20, consensus $5.53
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February 2, 2016
14:32 EDTALXNNotable companies reporting before tomorrow's open
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