CALT - Calliditas shares rise 10% as FDA grants priority review for Nefecon

Under Priority Review, the FDA has accepted Calliditas Therapeutics' (CALT) New Drug Application ((NDA)) for Nefecon, a down regulator of IgA1 for the treatment of IgA nephropathy (IgAN.)The FDA has set a PDUFA goal date of September 15, 2021. The NDA submission is based on positive data from Part A of the NefIgArd pivotal Phase 3 study of Nefecon which met its primary endpoint of proteinuria reduction compared to placebo as well as showed stabilization of eGFR at 9 months.The submission also includes clinical data from the Phase 2 NEFIGAN trial, which also met the same primary and secondary endpoints as the NefIgArd study.CALT shares up 9.5% premarket trading at $31.50.

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Calliditas shares rise 10% as FDA grants priority review for Nefecon