Shares in Calliditas crumble as FDA holds up Nefecon review

The market value of Swedish biopharma Calliditas Therapeutics (Nasdaq Stockholm: CALTX) dropped by 24% during Wednesday’s trading after a blow to its hopes for Nefecon.

Analysts have forecast that Nefecon, the company’s lead product candidate, could have global blockbuster potential, with peak sales in excess of $1 billion.

"Our NDA for Nefecon is the first time that the FDA is considering an approval on the basis of proteinuria as a surrogate endpoint for accelerated approval in IgA nephropathy"It is a proprietary, new oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of adults with the autoimmune renal disease primary IgA nephropathy (IgAN), for which there is a high unmet medical need and there are no approved treatments.