Mirum: FDA seeks additional Phase 3 volixibat PSC trial before filing planned 1H 2027 NDA

 

Mirum posts Q2 2026 net product sales of $176M, raises 2026 guidance to $680–$700M as FDA seeks another volixibat PSC Phase 3 trial

• FDA seeks an additional Phase 3 volixibat PSC trial before Mirum can file its planned 1H 2027 NDA.

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