FDA extends review of Mirum's LIVMARLI sNDA for PFIC; new PDUFA date March 13, 2024

Mirum Pharmaceuticals, Inc.

FDA extended PDUFA goal date to March 13, 2024, from original October 2023 target.
Extension due to FDA deeming Company's response to information request a major amendment.
Submission included further analysis of previously provided clinical data; no new data or studies requested.
LIVMARLI is under review for treatment of cholestatic pruritus in PFIC patients.
Company notes no additional FDA information requests beyond the major amendment.

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