FDA Approves Mirum's Livmarli For Liver Disease In Kids As Young As 5 Years: Analyst Bullish On Label Expansion Strategy
Portfolio Pulse from Vandana Singh
The FDA approved Mirum Pharmaceuticals Inc's Livmarli for cholestatic pruritus in patients aged 5+ with PFIC. The approval, based on Phase 3 MARCH study data, could lead to label expansion for younger patients. Analysts at HC Wainwright raised the price target for MIRM from $45 to $58 and reaffirmed a Buy rating, citing broad payor coverage focus in 2024 and potential label expansion. Concerns were noted about the current label's age restriction and additives in the medication, but a new formulation may address these issues.
March 14, 2024 | 7:41 pm
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POSITIVE IMPACT
FDA approval of Livmarli for PFIC in patients aged 5+ and potential label expansion could significantly impact Mirum Pharmaceuticals. Analysts at HC Wainwright raised the price target from $45 to $58, indicating strong future performance expectations.
The FDA's approval of Livmarli for a broader patient group and the subsequent analyst upgrade suggest a positive outlook for MIRM's stock. The focus on broad payor coverage and potential label expansion for younger patients in 2024 further supports growth expectations. However, concerns about the current label's age restriction and additives in the medication formulation introduce some uncertainty, mitigated by plans for a new formulation.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100