Mirum Pharmaceuticals Announces The FDA Has Granted Breakthrough Therapy Designation For Volixibat For Cholestatic Pruritus In Primary Biliary Cholangitis
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Mirum Pharmaceuticals has received Breakthrough Therapy Designation from the FDA for volixibat, a treatment for cholestatic pruritus in primary biliary cholangitis, based on positive interim results from a Phase 2b study.
October 10, 2024 | 12:42 pm
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Mirum Pharmaceuticals received FDA Breakthrough Therapy Designation for volixibat, enhancing its potential as a treatment for cholestatic pruritus in PBC. This designation is based on positive interim results from the Phase 2b VANTAGE study.
The FDA Breakthrough Therapy Designation is a significant regulatory milestone that can expedite the development and review process of volixibat. The positive interim results from the Phase 2b study suggest efficacy, which could lead to increased investor confidence and potential stock price appreciation.
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