IndustryCompany release

Mirum raises 2026 sales guidance to $715-720M after ATEBRIOZ approval

🇺🇸 Mirum Pharmaceuticals, Inc. (MIRM) · Tue 03 Nov 2026

The US rare-disease drugmaker reported Q3 net product sales of $185.7 million and flagged several regulatory submissions planned for the first half of 2027.

Mirum Pharmaceuticals reported net product sales of $185.7 million for the third quarter of 2026 on 3 November, and raised its full-year sales guidance to $715-720 million.

The quarter included the US Food and Drug Administration's approval and subsequent launch of ATEBRIOZ (zilurgisertib) for fibrodysplasia ossificans progressiva, an ultra-rare condition in which bone forms in soft tissue.

On the pipeline side, brelovitug received FDA Orphan Drug Designation for hepatitis delta. Mirum also reported positive Phase 3 results for two programmes: the EXPAND study of LIVMARLI and the AZURE-1 study of brelovitug.

The company said it plans several regulatory submissions in the first half of 2027. The summary available does not specify which products or indications they cover, nor which regulators will receive them. Orphan Drug Designation in the US is a status that offers development incentives; it is not a marketing authorisation.

What it means for your team

  • Regulatory teams tracking rare-disease filings should watch for Mirum's H1 2027 submissions, as details of products and agencies have not yet been given.
  • Market-access teams should note the ATEBRIOZ launch in fibrodysplasia ossificans progressiva as a new US treatment option in an ultra-rare indication.
  • Pharmacovigilance teams may expect new post-marketing safety obligations to accompany the ATEBRIOZ launch, though the source gives no specifics.

Company's press release (SEC filing): Mirum Pharmaceuticals, Inc. ↗

Article written by VigiEye from the official source (Mirum Pharmaceuticals, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

More Industry All →