Madrigal starts rolling submission for FDA approval of NASH treatment

 Madrigal Pharmaceuticals Inc.'s stock (MDGL) rose 5% Friday after the company said it has started a rolling submission of a New Drug Application to the U.S. Food and Drug Administration seeking accelerated approval of its resmetirom as a treatment for, nonalcoholic steatohepatitis, or NASH, with liver fibrosis. NASH is a more severe version of nonalcoholic fatty liver disease, or NAFLD, a range of conditions that occurs when excess fat builds up in liver cells. An estimated 25% of Americans have NAFLD, while about 20% of those patients end up developing NASH, in which the inflammation and cell damage caused by the fat buildup can cause cirrhosis and liver failure. The disease is one of the main reasons patients require liver transplants. Resmetirom was granted FDA Breakthrough Therapy designation in April for the treatment of NASH patients with liver fibrosis. Conshohocken, Pa.-based Madrigal is currently conducting a Phase 3 trial of the therapy. The company expects the NDA to be completed by July. For more, see: Inside the NASH drug boom: New drugs for a 'silent' liver disease that affects millions near FDA approval

https://www.morningstar.com/news/marketwatch/20230630500/madrigal-pharmaceuticals-stock-up-5-as-company-starts-rolling-submission-for-fda-approval-of-nash-treatment