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Calliditas Therapeutics Stock Falls As FDA Pushes Nefecon PDUFA Goal Date To December

  • The FDA has extended the PDUFA goal date for Calliditas Therapeutics AB’s (NASDAQ: CALT) application seeking accelerated approval for Nefecon.
  • Nefecon is an oral formulation targeting down-regulation of IgA1 to treat primary IgA Nephropathy (IgAN).
  • The new goal date is December 15 compared to the previous September 15.
  • The FDA has requested further analyses of the NeflgArd trial data, which the company has provided to the FDA. 
  • The amendment mainly provides additional eGFR and other related analyses to support further the proteinuria data provided in the application submission. 
  • In March, Calliditas filed for FDA approval using the Accelerated Approval Program.
  • Related Content: Calliditas Therapeutics Files US Application For Nefecon In Kidney Disease.
  • In April, the Nefecon application was granted priority review status from the FDA.
  • In May, Calliditas filed a Nefecon application to European Medicines Agency.
  • Related content: Benzinga’s Full FDA Calendar.
  • Price Action: CALT stock is down 8.62% at $22.37 during the premarket session on the last check Wednesday.

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