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.
Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechNewsHealth CareSmall CapMoversTrading IdeasGeneralBriefsEuropean Medicines Agency
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!