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May 12, 2014
08:13 EDTRLYPRelypsa reports phase 1 patiromers study reaches primary endpoint
Relypsa announced topline results from its Phase 1 onset-of-action study of patiromer, the final clinical trial planned to support a New Drug Application, or NDA), which the company expects to submit to the FDA in the third quarter of 2014. The study reached its primary endpoint in which an early onset of potassium lowering action was observed. Following the first dose of patiromer, reductions in mean serum potassium were observed at all examined time points, with statistical significance first demonstrated at the second measurement. Over the 48-hour treatment period, during which patiromer was dosed twice daily, the potassium lowering effect was sustained with a steady decline in mean serum potassium, with no loss of effect or rebound in mean potassium levels during night-time periods. The company said, "We are excited to share these topline results which support the rapid onset-of-action of patiromer and round out the drug's clinical story as a complement to our additional long-term studies, including chronic 12-month treatment data. These data are particularly encouraging as they were generated in a patient population at high risk for mortality due to moderate to severe hyperkalemia, a main focus of physicians as they address disease management and the use of RAAS inhibitor therapy."
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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