SEC Form 8-K filed by Mirum Pharmaceuticals Inc.
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| Item 8.01 | Other Events. |
On May 31, 2024, Mirum Pharmaceuticals, Inc. (the “Company”) announced that the European Committee for Medicinal Products for Human Use (“CHMP”) has adopted a positive opinion of LIVMARLI® (maralixibat) oral solution (“LIVMARLI”) for the treatment of Progressive Familial Intrahepatic Cholestasis (“PFIC”) in patients three months of age and older. The CHMP also concluded that LIVMARLI in PFIC brings significant clinical benefit based on improved efficacy and a major contribution to patient care compared to the already-approved treatment for PFIC. The CHMP positive opinion is the scientific recommendation to the European Commission for marketing authorization in Europe.
In addition, the Committee for Orphan Medicinal Products (“COMP”), has also recommended maintenance of Orphan Drug Designation for LIVMARLI in PFIC. A decision regarding the European Commission’s endorsement of the CHMP and COMP positive opinions is expected in the third quarter of 2024.
Forward Looking Statements
Certain statements contained in this report are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements regarding the anticipated timing of the decision regarding the European Commission’s endorsement of the CHMP and COMP positive opinions. The inclusion of forward-looking statements should not be regarded as a representation by the Company that any of these results will be achieved. Actual results may differ from those set forth in this report due to the risks and uncertainties associated with obtaining regulatory approvals for pharmaceutical product candidates, as well as risks and uncertainties inherent in the Company’s business, including those described in the Company’s other filings with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
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: May 31, 2024 | By: | /s/ Christopher Peetz | ||||
| Christopher Peetz | ||||||
| Chief Executive Officer | ||||||