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Monday, December 8, 2025

Mirum beckons Bluejay and its phase 3-stage hepatitis drug for $620M

 Mirum Pharmaceuticals is paying $620 million in cash and stock to buy Bluejay Therapeutics and its phase 3-stage hepatitis drug.

At the heart of the deal is brelovitug, an immunoglobulin G1 monoclonal antibody that targets the surface antigen on both the chronic hepatitis D virus (HDV) and the hepatitis B virus (HBV).

Bluejay read out data from a phase 2 study of brelovitug last month that demonstrated 100% HDV RNA response, along with improvements in liver enzyme levels. Meanwhile, the California-based biotech has been enrolling patients with HDV in a phase 3 trial that’s expected to report top-line data in the second half of next year.

To get its hands on the asset, Mirum is paying out $250 million in cash and $370 million in its own stock. There’s also the chance for Bluejay to receive up to $200 million in tiered sales-based milestones, should brelovitug make it to market.

Mirum—which already markets Livmarli for chronic itching due to Alagille syndrome—is eyeing up a potential FDA approval submission and commercial launch for brelovitug in 2027, according to the Dec. 8 release.

“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,” Mirum CEO Chris Peetz said in the release.

“Brelovitug in HDV leverages our deep expertise in rare liver disease and builds on the relationships we’ve established with key providers through the volixibat and Livmarli programs,” Peetz added. “The Bluejay team has done commendable work advancing brelovitug to this stage and we look forward to building on that progress to bring this important new treatment to people living with HDV.”

Bluejay’s CEO Keting Chu touted the drug as having the “potential to redefine HDV treatment.”

“Mirum’s rare disease leadership, commitment to rare liver communities and commercialization expertise make it the right company to carry this program forward globally,” Chu added.

Brelovitug will join a pipeline at Mirum that also includes the ileal bile acid transporter inhibitor volixibat, which is undergoing a pair of phase 2b studies for different types of cholangitis, as well as MRM-3379, a PDE4D inhibitor in a phase 2 trial for fragile X syndrome.

Alongside this morning’s acquisition, Mirum also announced a private placement of its common stock that is set to bring in around $200 million to the California-based biopharma. This funds will help bankroll the clinical development and commercial activities related to the buyout of Bluejay, Mirum explained.

https://www.fiercebiotech.com/biotech/mirum-nets-bluejay-and-its-phase-3-stage-hepatitis-drug-620m

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