2023-04-18 08:31:08 ET
- The U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation to Madrigal Pharmaceuticals' ( NASDAQ: MDGL ) resmetirom to treat patients with nonalcoholic steatohepatitis (NASH) with liver fibrosis.
- The company also said that the outcomes portion of a phase 3 MAESTRO-NASH biopsy trial completed enrollment.
- "It also reinforces our confidence in our regulatory strategy as we approach the new drug application (NDA) filing for resmetirom, which remains on track for Q2 2023. The filing is supported by the positive outcomes on reduction of liver fibrosis and resolution of NASH from the 52-week serial liver biopsy portion of MAESTRO-NASH," said Madrigal's CEO Paul Friedman.
- MDGL +3.29% to $265 premarket April 18
For further details see:
Madrigal rises on FDA breakthrough therapy tag for liver disease drug resmetirom