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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."
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November 21, 2014
12:02 EDTRLYPRelypsa says all endpoints met in Phase 3 Patiromer FOS program
Relypsa announced that results from the pivotal Phase 3 program of the company's lead product candidate, Patiromer for Oral Suspension, were published today in New England Journal of Medicine. The program was conducted under Special Protocol Assessment to evaluate the safety and efficacy of Patiromer FOS for the treatment of hyperkalemia in chronic kidney disease patients on renin-angiotensin-aldosterone system inhibitor therapy. All endpoints were met in the two-part Phase 3 program consisting of a treatment phase, which was designed to assess the ability of Patiromer FOS to correct hyperkalemia, and a placebo-controlled randomized maintenance phase designed to evaluate the effect of continued treatment with Patiromer FOS on potassium control and ability of patients to continue RAAS inhibitor therapy compared to placebo. In the treatment phase, among 237 evaluable patients receiving Patiromer FOS, the mean change in the serum potassium level was −1.01 mEq/L (P<0.001). At week 4, 76% of the patients were within the target potassium level. Subsequently, 107 patients were randomly assigned to Patiromer FOS or placebo for the maintenance phase.
November 17, 2014
08:18 EDTRLYPRelypsa reports all endpoints met in Patiromer FOS clinical trials
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November 10, 2014
16:02 EDTRLYPRelypsa reports Q3 EPS (57c), consensus (63c)
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