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Mirum Pharmaceuticals Enters into Definitive Agreement to Acquire Bluejay Therapeutics, Expanding Global Leadership in Rare Disease
-Planned acquisition of brelovitug for chronic hepatitis delta virus (HDV) with Breakthrough Therapy and PRIME designations -Anticipated to be highly
About this update from Mirum Pharmaceuticals, Inc.
[{"type":"text","content":"\n-Planned acquisition of brelovitug for chronic hepatitis delta virus (HDV) with Breakthrough Therapy and PRIME designations\n\n-Anticipated to be highly synergistic with Mirum’s liver expertise and proven global commercial capabilities\n\n-HDV: Large, high unmet-need rare liver disease with no FDA-approved therapies\n\n-Top-line Phase 3 results expected in 2H 2026\n\n-Conference call today, December 8, 2025 at 8:30 am ET/5:30 am PT\n\n FOSTER CITY, Calif.--(BUSINESS WIRE)--\nMirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a leading rare disease company, today announced its entry into a definitive agreement to acquire Bluejay Therapeutics, a privately held biotechnology company focused on viral and liver diseases. The transaction would add worldwide rights to brelovitug, a late-stage, fully human monoclonal antibody with Breakthrough Therapy and PRIME designations for chronic hepatitis delta virus (HDV) to Mirum’s portfolio of rare liver programs. This acquisition is expected to advance Mirum’s leadership in rare disease, build on its deep expertise in rare liver disorders and add a fourth potential registrational readout for the company over the next 18 months.\n\nBrelovitug is being evaluated in the AZURE Phase 3 registrational program for HDV, the most severe form of viral hepatitis. HDV occurs in people already infected with hepatitis B; nearly half of those affected progress to liver-related death within 10 years of diagnosis due to rapid progression to fibrosis, cirrhosis, hepatic decompensation and an increased risk of liver cancer. In Phase 2 studies, brelovitug demonstrated strong antiviral activity in HDV, achieving 100% HDV RNA response, along with improvements in liver enzyme levels and a favorable safety profile, with the most common adverse event being injection-site erythema. The ongoing global AZURE Phase 3 program is currently enrolling patients, with top-line data expected in 2H 2026 and potential BLA submission and launch in 2027.\n\n“This acquisition fits squarely with what we do best - advancing high-impact medicines for patients with rare diseases through disciplined development, regulatory innovation, and commercial excellence,” said Chris Peetz, Chief Executive Officer of Mirum Pharmaceuticals. “Brelovitug in HDV leverages our deep expertise in rare liver disease and builds on the relationships we’ve establi...