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May 20, 2014
08:14 EDTRLYPRelypsa announces commercial manufacturing agreement with DSM Fine Chemicals
Relypsa announced that it has entered into a multi-year commercial manufacturing and supply agreement with DSM Fine Chemicals Austria NFG GMBH & Co. KG for the active pharmaceutical ingredient for patiromer, the company's novel polymer in development for the treatment of hyperkalemia. DSM Fine Chemicals is a business unit of the newly formed DPx Holding B.V. which also owns Patheon Pharma Services and Banner Life Sciences. In addition to DSM Fine Chemicals, the company also has an agreement with Lanxess Corporation for the supply of API. Both Lanxess and DSM Fine Chemicals have manufactured and supplied API that was used during the company's clinical development program. Relypsa expects Lanxess will be the initial sole manufacturer named in its planned New Drug Application, or NDA. The company plans to submit a NDA supplement seeking approval for DSM Fine Chemicals as an additional manufacturer upon potential U.S. approval of patiromer.
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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