Mirum Pharmaceuticals said enrollment is complete in its Phase 3 AZURE-1 study and screening is complete in its Phase 3 AZURE-4 study evaluating brelovitug for chronic hepatitis delta virus. The company said these milestones support expected timing of topline 24-week data in the second half of 2026, with interim data from AZURE-1 expected in the second quarter. Mirum said AZURE-1 and AZURE-4 will form the basis of its planned U.S. biologics license application submission for brelovitug, which has FDA Breakthrough Therapy designation, and it reiterated an expectation for a potential U.S. BLA submission and launch in 2027.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Mirum Pharmaceuticals Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 202603050800BIZWIRE_USPR_____20260305_BW481077) on March 05, 2026, and is solely responsible for the information contained therein.
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