Travere Positioned To Seek Accelerated Approval In Rare Kidney Disorder
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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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.
Interview: delivering on its US business strategy during the COVID-19 pandemic has required a focus on communication, according to Calliditas CEO Renee Aguiar-Lucander.
Chinook launched less than two years ago to develop precision medicines for chronic kidney diseases and will have three drugs in the clinic in 2021, including a Phase III candidate for IgA nephropathy.