Calliditas surges on US FDA's approval for kidney disease drug

Calliditas Therapeutics AB

21/12/2023 11:37

** U.S.-listed shares of Sweden-based Calliditas
Therapeutics AB  CALTX.ST   CALT.O  rise ~15% premarket  
    ** Co said late on Wednesday the U.S. Food and Drug
Administration has given full approval for its drug to treat a
rare kidney disease, IgA Nephropathy (IgAN)  
    ** IgAN, also known as Berger's disease, occurs when a type
of antibody deposit builds up in the kidneys, causing
inflammation that damages its tiny filtering units
    ** The FDA decision makes the drug, branded as Tarpeyo, the
first to be granted full approval in the United States for IgAN,
ahead of Travere Therapeutics'  TVTX.O  Filspari, which won
accelerated approval earlier this year
    ** The disease affects about 130,000–150,000 people in the
United States, according to CALTX
    ** Up to last close, U.S.-listed stock up ~32% YTD 

 (Reporting by Mariam Sunny in Bengaluru)
 ((Mariam.ESunny@thomsonreuters.com;))