Company: MIRM
Filing Date: 2025-12-19
Form Type: 8-K
Source: 0001193125-25-326822
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Company: Mirum Pharmaceuticals, Inc.
Filing Date: 2025-12-19
Form: 8-K
Item: Item 8.01
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Item 8.01      Other Events.  

In November 2025, Mirum Pharmaceuticals, Inc. (the “ Company”) announced that it 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 of a generic version of Livmarli®(maralixibat). The Company subsequently received additional Notice Letters from Annora Pharma Private Limited, Zydus Lifesciences Global FZE and Zenara Pharma Private Limited (together with Sandoz, the “ ANDA Filers”).

On December 19, 2025, the Company filed patent infringement suits against the ANDA Filers in the United States District Court for the District of Delaware. The complaints allege that by filing their ANDAs, the ANDA Filers have infringed the Company’s Orange Book listed patents for LIVMARLI®, and seek an order that the effective date of FDA approval of each of the ANDAs shall be a date no earlier than the expiration of the last to expire of the asserted patents. As a result of these lawsuits, a30-monthstay prevents the FDA from issuing final approval of the ANDA Filers’ ANDAs.

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: December 19, 2025      By:                              /s/ Christopher Peetz    
                                                                Christopher Peetz        
                                                                Chief Executive Officer