Mirum Pharmaceuticals Files 8-K

TL;DR

Mirum filed an 8-K, but details are scarce. Watch for follow-up.

AI Summary

Mirum Pharmaceuticals, Inc. filed an 8-K on November 17, 2025, to report other events. The filing does not contain specific details about the nature of these events, dollar amounts, or definitive dates beyond the report date.

Why It Matters

This 8-K filing indicates that Mirum Pharmaceuticals has reported an event to the SEC, which could be material to investors. However, the lack of specific details requires further investigation.

Risk Assessment

Risk Level: medium — The filing is an 8-K, which typically reports material events, but the lack of specific information in this filing creates uncertainty.

Key Players & Entities

• Mirum Pharmaceuticals, Inc. (company) — Registrant
• November 17, 2025 (date) — Date of report
• Delaware (jurisdiction) — State of incorporation
• Foster City, California (location) — Principal executive offices

FAQ

Key Financial Figures

• $0.0001 — ich registered Common stock, par value $0.0001 per share MIRM Nasdaq Global Market

Filing Documents

• mirm-20251117.htm (8-K) — 27KB
• 0001759425-25-000057.txt ( ) — 140KB
• mirm-20251117.xsd (EX-101.SCH) — 2KB
• mirm-20251117_lab.xml (EX-101.LAB) — 21KB
• mirm-20251117_pre.xml (EX-101.PRE) — 12KB
• mirm-20251117_htm.xml (XML) — 3KB

01 Other Events

Item 8.01 Other Events. On November 17, 2025, Mirum Pharmaceuticals, Inc. (the "Company") received a Paragraph IV Certification Notice Letter (the "Notice Letter") from Sandoz, Inc. ("Sandoz") providing notification to the Company that Sandoz has submitted an Abbreviated New Drug Application ("ANDA") to the U.S. Food and Drug Administration ("FDA") seeking approval to manufacture, use or sell a generic version of Livmarli (maralixibat). In the Notice Letter, Sandoz alleges that five of the patents listed in the FDA Orange Book for Livmarli, U.S. Patent Numbers 11,229,647, 11,260,053, 11,376,251, 11,497,745 and 11,918,578, are invalid, unenforceable or will not be infringed by Sandoz's manufacture, use or sale of the generic product described in its ANDA submission. Under the Food and Drug Cosmetic Act, as amended by the Drug Price Competition and Patent Term Restoration Act of 1984, as amended, after receipt of a valid Paragraph IV Notice Letter, the Company may bring a patent infringement suit against Sandoz. If such suit is commenced within 45 days of receipt of the Notice Letter, this triggers an automatic 30-month stay, which would prevent the FDA from issuing final approval of Sandoz's ANDA until the expiration of the stay. The Company expects to receive additional Paragraph IV Certification Notice Letters in the future from ANDA filers seeking approval of a generic version of Livmarli. The Company intends to vigorously defend and enforce its intellectual property rights relating to Livmarli and plans to promptly file a patent infringement suit against Sandoz and any other ANDA filer with respect to Livmarli, seeking, among other remedies, a permanent injunction to prevent such parties from introducing a generic version of Livmarli that would infringe the Company's patents.

Forward-Looking Statements

Forward-Looking Statements

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. Mirum Pharmaceuticals, Inc. Date: November 17, 2025 By: /s/ Christopher Peetz Christopher Peetz Chief Executive Officer

View Full Filing

View this 8-K filing on SEC EDGAR