- Monday, Mirum Pharmaceuticals Inc MIRM announced positive topline results from its pivotal Phase 3 MARCH study of Livmarli (maralixibat) in progressive familial intrahepatic cholestasis (PFIC) age one to 17 years.
- The primary endpoint of improvement in pruritus severity in PFIC was statistically significant.
- PFIC is a rare genetic disorder that causes progressive liver disease, typically leading to liver failure.
- HC Wainwright says that with positive data, Mirum is expected to submit regulatory proceedings in early 2023.
- Upon approval and reimbursement, the conversion of about 100 patients is expected who are currently treated with Livmarli to represent the first wave of PFIC commercial demand.
- The analyst increased the price target to $68 from $63 and reaffirmed the Buy rating.
- Raymond James reiterates the Strong Buy rating, with a price target of $88, up from $75.
- Maralixibat showed pruritus and serum bile acid responses that were numerically higher than competitor Albireo Pharma Inc ALBO Bylvay (odevixibat) in its similar PEDFIC 1 study.
- The analyst says Maralixibat can potentially meet or exceed odevixibat's penetration in PFIC.
- Price Action: MIRM shares are up 14.8% at $22.99 on the last check Tuesday.
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