Madrigal Pharmaceuticals Rises As NASH Treatment Nears Finish Line

Madrigal Pharmaceuticals (MDGL) said Wednesday that it expects to get FDA clearance for its nonalcoholic steatohepatitis medication in March, sending the company's shares skyrocketing.
By: Medical Infralytix Pvt Ltd
CHAM, Switzerland - Nov. 9, 2023 - PRLog -- The FDA approved Madrigal's application for its medicine, resmetirom, in patients with NASH, or nonalcoholic steatohepatitis. NASH is a significant cause of liver transplants, and it is often asymptomatic until the illness is advanced. However, most NASH therapy trials to far have been disappointing. Madrigal might be the first to cross the finish line.

According to Leerink Partners analyst Thomas Smith, the FDA has said that it would not host an advisory committee meeting to consider the merits and dangers of Madrigal's medicine.

"While (new drug application) acceptance with priority review was our expectation, we believe the FDA's indication that they do not expect to convene an advisory committee will be viewed favorably, with positive implications for the quality of the pivotal (study) data and the level of regulatory alignment Madrigal has with FDA on the registrational (study goals)," he said.

MDGL stock increased 7.7% today, closing the regular session at 190.84.

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