Mirum Pharmaceuticals, Inc., a leading company in rare disease treatments, announced that it has entered into a definitive agreement to acquire Bluejay Therapeutics, a private biotechnology firm specializing in viral and liver diseases. The acquisition adds global rights to brelovitug, a late-stage, fully human monoclonal antibody with Breakthrough Therapy and PRIME designations for chronic hepatitis delta virus, or HDV. This addition strengthens Mirum’s rare liver program portfolio and supports the company’s goal of achieving four potential registrational readouts over the next 18 months.

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Brelovitug is currently being evaluated in the AZURE Phase 3 registrational program for HDV, the most severe form of viral hepatitis. HDV develops in people already infected with hepatitis B and nearly half of patients progress to liver-related death within ten years due to rapid fibrosis, cirrhosis, hepatic decompensation, and increased risk of liver cancer. Phase 2 studies showed that brelovitug achieved a 100 percent HDV RNA response, improved liver enzyme levels, and had a favorable safety profile. The most common adverse event reported was injection-site erythema. The global AZURE Phase 3 program is actively enrolling patients, with top-line results expected in the second half of 2026 and potential BLA submission and launch projected in 2027.

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Chris Peetz, Chief Executive Officer of Mirum Pharmaceuticals, commented on the acquisition, stating that it aligns perfectly with the company’s mission to advance high-impact medicines for rare diseases. He emphasized that brelovitug builds on Mirum’s expertise in rare liver disorders and the relationships the company has established through its volixibat and LIVMARLI programs. Peetz added that the Bluejay team has made significant progress in advancing brelovitug and that Mirum plans to expand on that work to deliver this treatment to patients living with HDV.

Keting Chu, Founder and CEO of Bluejay Therapeutics, said the company was founded to develop transformative therapies for viral and liver diseases. Chu noted that brelovitug progressed from a clinical development candidate to a global Phase 3 trial in just four years through collaboration with regulatory agencies such as the FDA and European Medicines Agency. He stated that Mirum’s rare disease leadership, industry relationships, and commercialization expertise make it the ideal partner to continue advancing brelovitug globally.

Under the terms of the agreement, Mirum will acquire all outstanding shares of Bluejay for $250 million in cash and $370 million in Mirum common stock. The deal also includes potential tiered sales-based milestone payments of up to $200 million in cash. Mirum common stock issued to Bluejay shareholders will be priced at $71.2085 per share. In connection with the acquisition, Mirum entered into a definitive agreement with a syndicate of healthcare investors for the sale of common stock or pre-funded warrants, generating approximately $200 million in gross proceeds before expenses. The funds from the private placement are intended to support clinical development and commercialization efforts following the acquisition. The Boards of Directors of both companies approved the transaction, which is expected to close in the first quarter of 2026, subject to regulatory approvals and other customary conditions.

Beyond brelovitug for HDV, Mirum plans to review strategic options for Bluejay’s additional investigational programs after closing. Morgan Stanley & Co. LLC served as the exclusive financial advisor to Mirum, while Cooley LLP acted as legal counsel. Centerview Partners LLC advised Bluejay financially, with Latham & Watkins LLP as legal counsel. J.P. Morgan Securities LLC also provided financial advice. Mirum has appointed Morgan Stanley & Co. LLC, Leerink Partners LLC, Cantor Fitzgerald & Co., Raymond James & Associates, Inc., and Citizens JMP Securities, LLC as placement agents for the private offering.

This acquisition reinforces Mirum’s commitment to advancing rare disease treatments and expanding its global leadership in liver-focused therapies. By integrating brelovitug into its portfolio, the company aims to bring new hope to patients suffering from HDV and related rare liver disorders.

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