Mirum posts late-stage trial win for hepatitis D drug (MIRM)

Mirum Pharmaceuticals (MIRM) reported that its Phase 3 AZURE-4 study of brelovitug for chronic hepatitis delta virus met its primary endpoint. 59% of patients on the 300 mg weekly dose and 44% on the 900 mg monthly dose achieved virologic response and ALT normalization, versus 0% in the delayed-treatment group. The drug was well-tolerated. MIRM shares traded at $93.18 after hours.

Mirum Pharmaceuticals reported that brelovitug met the primary endpoint in its Phase 3 AZURE-4 study for chronic hepatitis delta. At week 24, 59% of patients on 300 mg weekly and 44% on 900 mg every four weeks achieved the primary endpoint, compared to 0% with delayed treatment. The company plans to submit a BLA in the first half of 2027 and expects a potential U.S. launch in Q4 2027 if approved.

Mirum Pharmaceuticals, Inc. (MIRM) filed an SEC Form 8-K — Other Events. Item 8.01 Other Events. Announcement that Primary Endpoint Met in AZURE-4 Phase 3 Study and Highlights Long-Term Brelovitug Data Presented at American Association for the Study of Liver Diseases (“AASLD”) On November 10, 2026, Mirum Pharmaceuticals, Inc. (the “Company”) announced

Mirum Pharmaceuticals (MIRM) reported that brelovitug met the primary endpoint in the Phase 3 AZURE-4 trial for chronic hepatitis delta virus, with 59% and 44% of patients achieving the combined endpoint in the two treatment arms. The drug has FDA Breakthrough Therapy and Orphan Drug Designations. Mirum plans to submit a Biologics License Application to the FDA in the first half of 2027.

Mirum (MIRM) reported Q3 2026 net product sales of $186M, up from $133M last year. LIVMARLI drove growth with $133M in sales. The company raised full-year guidance to $715M-$720M. Mirum expects 5 potential regulatory submissions by 2027, including for volixibat, Brelovitug, and Atebrioz. The company also announced positive clinical trial results for its pipeline.

HC Wainwright & Co. kept its Buy rating on Mirum Pharmaceuticals and increased its price target to $202 from $200. This implies a 132.1% upside from the Nov 3 close of $87.03. Other recent analyst targets for the company range from $145 to $160.