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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Securities registered pursuant to Section 12(b) of the Act:
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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 October 17, 2023, Mirum Pharmaceuticals, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (the “FDA”) has extended the review of the Supplemental New Drug Application (“sNDA”) for LIVMARLI® (maralixibat) oral solution for the treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (“PFIC”). The new Prescription Drug User Fee Act (“PDUFA”) date is March 13, 2024.
The FDA extended the PDUFA goal date to allow time for a full review of a submission provided in response to an FDA information request, which the FDA deemed a major amendment. The submission comprised further analysis of certain clinical information that was previously provided to the FDA by the Company. No additional data or studies have been requested.
Forward Looking Statements
This Current Report on Form 8-K contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, these statements are often identified by the words “look forward to”, “will,” “may”, “might”, “believes”, “anticipates”, “plans”, “expects”, “intends,” “potential” or similar expressions. In addition, expressions of strategies, intentions or plans are also forward-looking statements. Such forward-looking statements include, but are not limited to, references to: the updated PDUFA date for the PFIC sNDA and the timeline for the FDA’s review of Company-submitted data. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Other factors that might cause such a difference include those discussed in the Company’s filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
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: October 17, 2023 | By: | /s/ Christopher Peetz | ||||
| Christopher Peetz | ||||||
| President and Chief Executive Officer | ||||||
Document and Entity Information |
Oct. 17, 2023 |
|---|---|
| Cover [Abstract] | |
| Amendment Flag | false |
| Entity Central Index Key | 0001759425 |
| Document Type | 8-K |
| Document Period End Date | Oct. 17, 2023 |
| 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 |