Company: MIRM
Filing Date: 2025-12-08
Form Type: 8-K
Source: 0001193125-25-310611
Chunk: 3

Company: Mirum Pharmaceuticals, Inc.
Filing Date: 2025-12-08
Form: 8-K
Item: Item 7.01
Chunk 3
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itug in HDV in the first half of 2027 followed by a potential approval and launch, if approved, in the second half of 2027.

The Company anticipates receipt of top-linedata from the VISTAS Phase 2b clinical trial of volixibat for the treatment of primary sclerosing cholangitis (“ PSC”) in the second quarter of 2026. In addition, the Company expects to submit a new drug application (“ NDA”) to the FDA for volixibat for the treatment of PSC in the second half of 2026, with both receipt of such potential approval and a subsequent launch of volixibat for the treatment of PSC, if approved, to occur in the first half of 2027. The Company also anticipates receipt of top-linedata from the Phase 3 Livmarli EXPAND clinical trial for the treatment of other ultra-rare cholestatic pruritus indications, the Phase 2b volixibat clinical trial for the treatment of primary biliary cholangitis and the Phase 2 clinical trial of MRM-3379for the treatment ofFragile-XSyndrome in 2027.