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Positive feedback from FDA significantly benefits ongoing NefIgArd pivotal Phase 3 study

Calliditas Therapeutics AB (publ) (“Calliditas”) today announced that it has obtained written feedback from the US Food and Drug Administration (FDA) that will have a significant impact on the ongoing pivotal Phase 3 study, NefIgArd, with Calliditas’ leading drug candidate Nefecon for the chronic autoimmune kidney disease IgA Nephropathy (IgAN).
Calliditas has had an active dialogue with the FDA around the NefIgArd study during the year and has received acceptance of a design change of the Part B of the NefIgArd study, which significantly simplifies and enhances the design of the

Source: Positive feedback from FDA significantly benefits ongoing NefIgArd pivotal Phase 3 study

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