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News Breaks
March 14, 2014
17:33 EDTTKPYY, SCMPSucampo, Takeda say that Amitiza NDA will not be filed in second half of 2014
Sucampo Pharma Americas, a wholly owned subsidiary of Sucampo Pharmaceuticals (SCMP), and its development and commercialization partner's subsidiary Takeda Pharmaceuticals (TKPYY) announced that the New Drug Application, NDA, for the liquid formulation of Amitiza will not be filed in the second half of 2014. In preliminary pre-NDA meeting comments, the FDA informed Sucampo that it would require additional data to characterize pharmacokinetics of the new formulation. As a result of this outcome in conjunction with the FDA feedback, Sucampo and Takeda are now assessing next steps, which may include formulation modification.
News For SCMP;TKPYY From The Last 14 Days
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April 15, 2015
08:33 EDTTKPYYFDA panel results positive for Merck, says SunTrust
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April 14, 2015
07:15 EDTTKPYYFDA Endocrinologic & Metabolic Drugs Advisory Committee holds a meeting
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07:13 EDTSCMPSucampo repeats FY15 EPS view 55c-65c, consensus 58c
Sees FY15 net income $25M-$30M. Comments from slides that will be presented at the 14th Annual Needham Healthcare Conference.
April 13, 2015
08:54 EDTTKPYYAstraZeneca has negative read through from briefing docs, says SunTrust
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April 8, 2015
10:01 EDTSCMPOn The Fly: Analyst Initiation Summary
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06:31 EDTSCMPSucampo initiated with a Buy at Guggenheim
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April 7, 2015
10:55 EDTSCMPSucampo, NetEase, and TAL Education recommended by Navellier
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