Shares of Madrigal Pharmaceuticals (NASDAQ:MDGL) skyrocketed by more than 200% in morning trading on Monday, after announcing encouraging topline results from the pivotal Phase 3 MAESTRO-NASH (non-alcoholic steatohepatitis) clinical trial of resmetirom. NASH is also called non-alcoholic fatty liver disease.
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The MAESTRO-NASH clinical trial was a 52-week serial liver biopsy Phase 3 study which had enrolled around 950 patients. In this trial, resmetirom “achieved both primary endpoints and potentially clinically meaningful effects with both daily oral doses, 80 mg and 100 mg, relative to placebo”
Resmetirom was found to be well-tolerated and safe in this trial.
MDGL intends to file a New Drug Application (NDA) in the first half of next year seeking approval for resmetirom.
Wall Street analysts are bullish about MDGL stock with a Strong Buy consensus rating based on three Buys and one Hold.