UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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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-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of 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 November 29, 2022, Mirum Pharmaceuticals, Inc. (the “Company”) determined that it will discontinue the Company’s OHANA Phase 2b clinical trial of volixibat in intrahepatic cholestasis of pregnancy (“ICP”) due to enrollment feasibility. ICP is a setting of cholestasis during pregnancy with pruritus and elevated bile acid levels that can lead to fetal complications. An interim analysis did show that patients treated with volixibat saw meaningful reductions in serum bile acids and pruritus; however, the Company has decided to discontinue the OHANA Phase 2b clinical trial due to the unique challenges in enrollment in the high-risk pregnancy setting, which allows the Company to prioritize other programs.
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 29, 2022 | By: | /s/ Christopher Peetz | ||||
| Christopher Peetz | ||||||
| President and Chief Executive Officer | ||||||
Document and Entity Information |
Nov. 29, 2022 |
|---|---|
| Cover [Abstract] | |
| Amendment Flag | false |
| Entity Central Index Key | 0001759425 |
| Document Type | 8-K |
| Document Period End Date | Nov. 29, 2022 |
| Entity Registrant Name | Mirum Pharmaceuticals, Inc. |
| Entity Incorporation State Country Code | DE |
| Entity File Number | 001-38981 |
| Entity Tax Identification Number | 83-1281555 |
| Entity Address, Address Line One | 950 Tower Lane |
| Entity Address, Address Line Two | Suite 1050 |
| Entity Address, City or Town | Foster City |
| Entity Address, State or Province | CA |
| Entity Address, Postal Zip Code | 94404 |
| City Area Code | 650 |
| Local Phone Number | 667-4085 |
| Written Communications | false |
| Soliciting Material | false |
| Pre Commencement Tender Offer | false |
| Pre Commencement Issuer Tender Offer | false |
| Security 12b Title | Common stock, par value $0.0001 per share |
| Trading Symbol | MIRM |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | true |
| Entity Ex Transition Period | true |