Calliditas' Kinpeygo Receives CHMP Backing For Kidney Disease

  • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional approval for Calliditas Therapeutics AB's CALT Kinpeygo for primary immunoglobulin A (IgA) nephropathy (IgAN).
  • The opinion covers adult patients at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram. 
  • Also See: Calliditas Shares Rally After FDA's Accelerated Approval For Budesonide For Kidney Disease.
  • If confirmed by the European Commission (EC), Kinpeygo will be the first and only approved treatment for IgAN, a rare, progressive autoimmune disease of the kidney. 
  • Upon approval Kinpeygo, which was developed under Nefecon, will be marketed exclusively by STADA Arzneimittel AG.
  • A final decision by the EC is anticipated in Q3 2022. 
  • Price Action: CALT shares are up 14.50% at $18.31 during the market session on the last check Thursday.
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