Brelovitug - (AZURE)

August 5, 2026: Mirum Pharmaceuticals (NASDAQ: MIRM) reported Q2 2026 results and highlighted multiple pipeline catalysts. Volixibat received FDA Breakthrough Therapy and Orphan Drug designations for cholestatic pruritus due to primary sclerosing cholangitis (PSC). Mirum said the Phase 2b VISTAS study in PSC met its primary endpoint with statistically significant, clinically meaningful pruritus reductions, but after a pre-NDA meeting the FDA recommended a Phase 3 study; Mirum plans further FDA discussions before a potential NDA submission now targeted for H1 2027. In primary biliary cholangitis (PBC), enrollment is complete in the Phase 2b VANTAGE study, with topline data expected in Q1 2027.

Brelovitug: topline Phase 3 results from AZURE-1 and AZURE-4 in chronic hepatitis delta virus are expected in Q3 2026 and Q4 2026, respectively.

LIVMARLI: topline Phase 3 EXPAND data in additional rare cholestatic pruritus settings are expected in Q4 2026.

Zilurgisertib: Mirum presented positive pivotal Phase 2 PROGRESS data in fibrodysplasia ossificans progressiva at ENDO 2026; the NDA has FDA Priority Review with a PDUFA date of September 26, 2026.

Commercially, Q2 net product sales were $176.2 million, and 2026 guidance was raised to $680 million-$700 million.