Calliditas to seek Conditional Marketing Authorization in Europe
Stockholm’s Calliditas Therapeutics (STO: CALTX) has moved one step closer to securing European Medicines Agency (EMA) approval for its lead compound nefecon, the firm said in a statement on Monday.
The Swedish biotech, which is developing the candidate for IgA nephropathy (IgAN), said the EMA had “provided positive guidance related to a Conditional Marketing Authorization (CMA).”
The agency agreed that it could support CMA assessment, “subject as usual to the strength of the full data set presented at the time of filing.”
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