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Mirum: VISTAS Phase 2b volixibat nakamit ang pangunahing endpoint sa PSC
Ang VISTAS Phase 2b study ay nakamit ang pangunahing endpoint nito, na nagpapakita ng statistically significant 1.64-point placebo-adjusted improvement sa pruritus (p<0.0001) sa mga pasyenteng may PSC na may katamtaman hanggang malubhang pangangati. Ang kumpanya ay nagbabalak na magdaos ng pre-NDA meeting kasama ang FDA sa tag-init ng 2026 at magsumite ng NDA sa H2 2026. Ang topline data mula sa hiwalay na VANTAGE Phase 2b study sa PBC ay inaasahang lalabas na ngayon sa Q1 2027.
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8-K false 0001759425 0001759425 2026-05-04 2026-05-04 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 4, 2026 Mirum Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 001-38981 83-1281555 (State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.) 989 East Hillsdale Boulevard Suite 300 Foster City , California 94404 (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code: (650) 667-4085 N/A (Former name or former address, if changed since last report) Check the appropriate box