MIRM - Mirum Pharmaceuticals: After Phase 2 Miss An iBAT Inhibitor On Deck To Drive Value

2024-04-22 15:04:08 ET

Summary

• The FDA approved Mirum Pharmaceuticals, Inc.'s Limvarli for treatment of cholestatic pruritus in patients with Progressive Familial Intrahepatic Cholestasis; Potential for further label expansion in younger patients possible due to positive MARCH study.
• Interim results from VANTAGE study using Volixibat for patients with PBC are expected 1st half of 2024; The global primary biliary cholangitis therapeutics market is projected to reach $1.4 billion by 2032.
• Interim results from VISTAS study using Volixibat for patients with PSC expected 1st half 2024; The global Primary Sclerosing Cholangitis market is expected to reach $586.8 million by 2034.
• Total net product revenues of $178.9 million for the full-year ending December 2023, compared to the prior year ending December 2022 with net product revenues of only $75.1 million in sales.

Mirum Pharmaceuticals, Inc. ( MIRM ) had a huge miss with a phase 2 study that it was advancing with the use of its drug Limvarli [maralixibat] from its phase 2b EMBARK study for the treatment of patients with biliary artesia. Despite this setback, there is still plenty of value left for shareholders to consider here. For starters, it was able to obtain FDA approval of Limvarli for the treatment of cholestatic pruritus in patients 5 years of age and older with progressive familial intrahepatic cholestasis [PFIC]. Not only that, but it plans on a label expansion for this patient population later in the year as well. Despite this expansion occurring for Limvarli, there are two other critical reasons to keep an eye on this biotech....

For further details see: