Mirum's Brelovitug Meets Phase 3 Goals In Chronic Hepatitis Delta Study

Mirum Pharmaceuticals received FDA approval for Atebrioz (zilurgisertib) to treat fibrodysplasia ossificans progressiva (FOP), a rare bone disease. The drug, a once-daily pill, showed significant reduction in new lesion volume in clinical trials. Mirum joins Regeneron and Ipsen in offering treatments for FOP, with Atebrioz being the third approved option in recent months. The company plans to launch the drug in October, with pricing details to be announced.

Mirum Pharmaceuticals' phase 3 trial of brelovitug for chronic hepatitis delta met its primary endpoint, with response rates of 56% and 45% for the 300 mg and 900 mg doses, respectively. The results surpassed the delayed treatment arm and showed improvement over phase 2b data. Analysts note potential commercial differentiation. Mirum aims for FDA approval by mid-2025, following positive Azure-4 trial data expected in Q4 2024.

Mirum Pharmaceuticals, Inc. (MIRM) filed an SEC Form 8-K — Other Events. Item 8.01 Other Events. Approval of Atebrioz On September 25, 2026, Mirum Pharmaceuticals, Inc. (the “Company”) and Incyte Corporation (“Incyte”) announced that the U.S. Food and Drug Administration (“FDA”) approved Atebrioz™ (zilurgisertib) tablets to reduce the volume of total

Bristol Myers Squibb (BMY) awaits an FDA decision on Sept. 30 for expanding Camzyos to adolescents with obstructive hypertrophic cardiomyopathy. Egetis Therapeutics (EGTX) faces a Sept. 28 decision for Emcitate for MCT8 deficiency. Scholar Rock (SRRK), Biofrontera (BFRI), and Mirum Pharmaceuticals (MIRM) received early FDA approvals for their respective drugs. Mirum's shares rose 3% in pre-market trading.

Bristol Myers Squibb (BMY) and Egetis Therapeutics (EGTX) await FDA decisions on drug expansions. Biofrontera (BFRI), Scholar Rock (SRRK), and Mirum Pharmaceuticals (MIRM) received early approvals. BMY's Camzyos, if approved, would be the first cardiac myosin inhibitor for adolescents with oHCM. EGTX's Emcitate could be the first FDA-approved treatment for MCT8 deficiency. SRRK and BFRI shares declined post-approval, while MIRM shares rose.

Mirum Pharmaceuticals (MIRM) and Incyte (INCY) announced FDA approval of Atebrioz (zilurgisertib) for treating fibrodysplasia ossificans progressiva (FOP) in patients aged 12+. The oral treatment, developed by Incyte and licensed to Mirum, will be available in the U.S. in October. The companies' patient support program may reduce costs to $0/month for eligible patients. Regulatory reviews are ongoing in Europe. MIRM closed at $89.70, up 0.38%.