UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 13, 2022
Mirum Pharmaceuticals, Inc.
(Exact name of Registrant as Specified in Its Charter)
| Delaware | 001-38981 | 83-1281555 | ||
|
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
|
950 TowerLane Suite 1050 Foster City, California |
94404 | ||
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant's Telephone Number, Including Area Code: 650667-4085
N/A
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-Kfiling is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ |
Soliciting material pursuant to Rule 14a-12under the Exchange Act (17 CFR 240.14a-12) |
| ☐ |
Pre-commencementcommunications pursuant to Rule 14d-2(b)under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ |
Pre-commencementcommunications pursuant to Rule 13e-4(c)under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
|
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
||
| Common stock, par value $0.0001 per share | MIRM | Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2of the Securities Exchange Act of 1934 (§ 240.12b-2of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
| Item 8.01 |
Other Events. |
On December 13, 2022, Mirum Pharmaceuticals, Inc. (the "Company") announced that the European Commission had granted marketing authorization to the Company for the Company's lead product LIVMARLI® (maralixibat) oral solution ("LIVMARLI") for the treatment of cholestatic pruritus in patients with Alagille syndrome ("ALGS") two months of age and older. The approval follows a positive opinion granted by the European Committee for Medicinal Products for Human Use in September 2022. LIVMARLI is the first and only approved treatment in both the European Union and the United States to treat ALGS, which affects one out of 30,000 people globally. The approval authorizes the Company to market LIVMARLI in all European Union member states.
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 13, 2022 | By: |
/s/ Christopher Peetz |
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| Christopher Peetz | |||||
| President and Chief Executive Officer |
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Disclaimer
Mirum Pharmaceuticals Inc. published this content on 13 December 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 December 2022 21:34:48 UTC.