Calliditas Therapeutics AB
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Latest From Calliditas Therapeutics AB
The Swiss group has delivered on its promise to secure more deals in the nephrology space by bagging the rights in Europe, Australia and New Zealand to sparsentan, which is deep into a Phase III program for focal segmental glomerulosclerosis and IgA nephropathy.
Shares in Sweden's Calliditas have taken a tumble on the news that the US FDA has pushed back the action date for its immunoglobulin A nephropathy Nefecon. However, the company, and certain analysts, are less worried, believing the delay is just a blip.
In the first half of 2021, just six requests from companies seeking accelerated assessment of their planned EU marketing authorization applications were granted; 11 were rejected. The outcomes of five decided on in July and August are still unknown.
With interim Phase III data showing threefold reduction in proteinuria reduction compared to SOC, Travere plans to seek accelerated US and EU approval of sparsentan in immunoglobulin A nephropathy.
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