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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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March 30, 2015
07:24 EDTRLYPStifel to hold a bus tour
BioTrek: 2015 West Coast Healthcare Therapeutics Bus Tour travels throughout San Francisco on March 30-April 1.
March 27, 2015
15:31 EDTRLYP5AM Ventures III lowers stake in Relypsa to 5.89% from 9.38%
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March 26, 2015
19:04 EDTRLYPRelypsa Phase 3 data says Patiromer FOS prevents recurrence of hyperkalemia
Relypsa announced that data from a Phase 3 clinical program showing that Patiromer for Oral Suspension, or Patiromer FOS, the company's lead product candidate, was effective in reducing potassium levels and preventing a recurrence of hyperkalemia in patients with advanced chronic kidney disease receiving ongoing treatment with renin-angiotensin-aldosterone system inhibitors were presented as a poster at the National Kidney Foundation 2015 Spring Clinical Meeting. The results are from a sub-group analysis of the two part Phase 3 trial, OPAL-HK, conducted under a Special Protocol Assessment with the FDA that was led by Matthew Weir, M.D., Professor and Director, Division of Nephrology, University of Maryland School of Medicine. The Phase 3 OPAL-HK trial primary outcomes, previously published in the New England Journal of Medicine, were combined with results from Relypsa's broader clinical development program to support the company's New Drug Application, or NDA, for Patiromer FOS. The FDA has assigned a Prescription Drug User Fee Act, or PDUFA, action date of October 21 for completion of the review of the NDA.

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