Update: Adds analyst comments from Goldman Sachs, Truist
Madrigal Pharmaceuticals ( NASDAQ: MDGL ) closed up 268% in Monday trading after releasing late-stage results on resmetirom for nonalcoholic steatohepatitis ( NASH ) and liver fibrosis.
NASH results in the MAESTRO-NASH trial showed that patients on resmetirom 80 mg and 100 mg after 52 weeks of treatment had, respectively, NASH resolution of 26% and 30% compared to 10% for placebo.
For liver fibrosis, a ?1-stage improvement in fibrosis with no worsening of NAFLD Activity Score (NAS) was seen in, respectively, 24% and 26% of resmetirom 80 mg and 100 mg patients and 14% of placebo patients.
In a secondary endpoint of LDL-C lowering, resmetirom 80 mg and 100 mg led to a reduction of 12% and 16% compared to a 1% gain in the placebo group.
Resmetirom was well tolerated with the frequency of adverse events similar in the treatment and placebo cohorts.
Madrigal ( MDGL ) plans on filing an NDA for the candidate seeking accelerated approval for non-cirrhotic NASH with liver fibrosis.
The company currently has four phase 3 trials in progress for resmetirom for NASH.
In response to the data, Goldman Sachs increased its probability of success for resmetirom to 90% from $75% and its price target to $375 from $178 (~488% upside based on Friday's close).
Viking Therapeutics ( VKTX ), which has VK2809 in phase 2 for NASH, closed up 74% on the news.
Truist on Monday called VK2809 "a more potent drug" with phase 2 data expected in H1 2023.
BioSci Capital Partners recently called Madrigal ( MDGL ) a buy.
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Madrigal closes up 268% on positive late-stage results for NASH candidate resmetirom