What happened
Shares of Calliditas Therapeutics (CALT 0.26%) were up more than 14% as of 1 p.m. ET on Thursday. The Swedish pharmaceutical company may have benefited when a competitors' drug announced a mixed trial result. The stock is up 29% this year.
So what
Calliditas specializes in rare disease. Its only marketed therapy is Tarpeyo, which got accelerated approval from the Food and Drug Administration (FDA) in 2021 to be used against IgA nephropathy (IgAN). The disease is an autoimmune kidney disorder that is caused by a buildup of antibodies that can cause inflammation and kidney damage. On Thursday, Travere Therapeutics said that its therapy, Filspari, met most, but not all of its endpoints to treat IgAN.
The news may give Tarpeyo an inside track to full approval, though that is far from a guarantee. The trick with many kidney drugs is they can cause toxins to build up in the kidney. The FDA in August, accepted Calliditas' submission for a supplemental New Drug Application for Tarpeyo and granted Priority Review. The drug's Prescription Drug User Fee Act (PDUFA) goal date is Dec. 20. Calliditas is scheduled to release updated phase 3 trial data on Tarpeyo at the 17th International Symposium on IgA Nephropathy next week in Tokyo.
Now what
In a preliminary second-quarter report on Aug. 17, Calliditas said it expects that Tarpeyo will bring in between $100 million to $120 million this year in the U.S. It also said that revenue in the quarter is likely to be 269.4 million Swedish kronor (SEK), roughly $24.12 million, up 320% year over year, with its net loss being 75.2 million SEK ($6.73 million) compared to a net loss of 209.8 million SEK ($18.78 million) in the same period a year ago.