Calliditas Shares Rally After FDA's Accelerated Approval For Budesonide For Kidney Disease

The FDA has approved Calliditas Therapeutics AB's CALT Tarpeyo (budesonide) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression.

• This indication is approved under accelerated approval. 
• It has not been established whether Tarpeyo slows kidney function decline in patients with IgAN. 
• Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.
• Related Link: Calliditas Takes 100% Control Of Genkyotex.
• The accelerated approval is based on Phase 3 study data that showed a statistically significant 34% reduction in proteinuria from baseline vs. 5% with RASi alone (n=102) at nine months. 
• The treatment effects for the primary endpoint of UPCR at nine months were consistent across key subgroups, including key demographic and baseline disease characteristics.
• It is expected that Tarpeyo will be available in the U.S. early in the Q1 of 2022. 
• Related content: Benzinga's Full FDA Calendar.
• Price Action: CALT shares are up 39% at $25.90 during the premarket session on the last check Thursday.