- 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 (NASDAQ: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.
