Calliditas Therapeutics Stock Falls As FDA Pushes Nefecon PDUFA Goal Date To December

The FDA has extended the PDUFA goal date for Calliditas Therapeutics AB's CALT application seeking accelerated approval for Nefecon.
Nefecon is an oral formulation targeting down-regulation of IgA1 to treat primary IgA Nephropathy (IgAN).
The new goal date is December 15 compared to the previous September 15.
The FDA has requested further analyses of the NeflgArd trial data, which the company has provided to the FDA.
The amendment mainly provides additional eGFR and other related analyses to support further the proteinuria data provided in the application submission.
In March, Calliditas filed for FDA approval using the Accelerated Approval Program.
Related Content: Calliditas Therapeutics Files US Application For Nefecon In Kidney Disease.
In April, the Nefecon application was granted priority review status from the FDA.
In May, Calliditas filed a Nefecon application to European Medicines Agency.
Related content: Benzinga's Full FDA Calendar.
Price Action: CALT stock is down 8.62% at $22.37 during the premarket session on the last check Wednesday.