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March 26, 2014
12:00 EDTRLYPRelypsa falls 13.4%
Relypsa is down 13.4%, or $5.47, to $35.42
News For RLYP From The Last 14 Days
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December 16, 2014
08:09 EDTRLYPRelypsa appoints Stephen Harrison as Chief Scientific Officer
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December 15, 2014
11:35 EDTRLYPRelypsa price target raised to $63 from $58 at Wedbush
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08:58 EDTRLYPRelypsa initiated with a Buy at BofA/Merrill
Target $55.
08:07 EDTRLYPRelypsa announces FDA acceptance of NDA for Patiromer FOS
Relypsa announced that the FDA has accepted for filing the New Drug Application, or NDA, for Patiromer for Oral Suspension, or Patiromer FOS, for the treatment of hyperkalemia, a serious condition defined as abnormally elevated levels of potassium in the blood. Relypsa expects written notification of NDA acceptance along with the Prescription Drug User Fee Act, or PDUFA, date as well as a preliminary indication regarding the need for an Advisory Committee meeting, in the day-74 letter from the FDA in early January 2015. The NDA is supported by eight clinical trials, including a Phase 3 program that was conducted under a Special Protocol Assessment, a long-term treatment trial that evaluated the safety and efficacy of Patiromer FOS in patients for up to one year, and an onset-of-action study that evaluated the time to potassium lowering action.

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