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News Breaks
March 14, 2014
17:33 EDTSCMP, TKPYYSucampo, 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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January 30, 2015
16:04 EDTSCMPSucampo appoints Andrew Smith CFO
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06:46 EDTSCMPSucampo completes European Mutual Recognition Procedure for AMITIZA
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January 20, 2015
10:55 EDTSCMPSucampo founders' share registration removes overhang, says Cantor
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08:44 EDTSCMPSucampo share sales to remove big overhang, says Roth Capital
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January 16, 2015
16:46 EDTSCMPSucampo files to sell 25.68M shares of Class A common stock for holders
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