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News Breaks
March 7, 2014
13:10 EDTREGN, SNYRegeneron, Sanofi advised by FDA of adverse events in PCSK9 inhibitor class
In a filing with the SEC earlier today, Sanofi (SNY) disclosed that the company and Regeneron (REGN) have been advised by the FDA that it has become aware of neurocognitive adverse events in the PCSK9 inhibitor class. Neither company knows the circumstances under which the FDA became aware of these adverse events or whether these adverse events were observed with a drug candidate tested as monotherapy or in combination with a statin or other cholesterol-lowering agent. The FDA has requested that Sanofi and Regeneron make an assessment of potential neurocognitive adverse events across the global development program for alirocumab, especially in the longer-term studies. While neither company is aware of any neurocognitive adverse event signal relating to alirocumab, if this or another adverse event signal is detected, the further development of alirocumab may be delayed or fail, or its commercial value diminished, which could severely harm future prospects.
News For REGN;SNY From The Last 14 Days
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June 26, 2015
05:25 EDTREGNRegeneron reports approval of Eylea by Japan
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June 25, 2015
14:03 EDTSNYSanofi initiated with a Buy at HSBC
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