Mirum Pharmaceuticals Announces New PDUFA Date Of March 13, 2024 For LIVMARLI For The Treatment Of Cholestatic Pruritus In Progressive Familial Intrahepatic Cholestasis
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Mirum Pharmaceuticals, Inc. (NASDAQ:MIRM) announced that the FDA has extended the review of the sNDA for LIVMARLI® (maralixibat) oral solution for the treatment of cholestatic pruritus in patients with PFIC. The new PDUFA date is March 13, 2024. The FDA extended the date to allow time for a full review of a submission provided in response to an FDA information request. No additional data or studies have been requested.
October 17, 2023 | 8:37 pm
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The FDA's extension of the review date for Mirum Pharmaceuticals' LIVMARLI® could delay the drug's potential market entry, potentially impacting the company's short-term revenues.
The FDA's decision to extend the review of the sNDA for LIVMARLI® means that the drug's potential market entry could be delayed. This could impact Mirum Pharmaceuticals' short-term revenues as the company may have been counting on the revenue from the drug's sales. However, no additional data or studies have been requested, which could be a positive sign that the FDA is simply taking more time to thoroughly review the submission.
CONFIDENCE 90
IMPORTANCE 75
RELEVANCE 100