MDGL - Intercept to face FDA AdCom meeting on NASH candidate in May

2023-03-10 09:23:14 ET

The FDA announced on Friday that a group of independent experts would meet in May to discuss the marketing application for Obeticholic Acid (OCA), a liver disease candidate developed by Intercept Pharmaceuticals ( NASDAQ: ICPT ) for nonalcoholic steatohepatitis (NASH).

Intercept ( ICPT ) fell ~2% lower in the pre-market after the news while the rival NASH drug developer Madrigal Pharmaceuticals ( MDGL ) has added ~5% .

According to the FDA, its Gastrointestinal Drugs Advisory Committee will meet on May 19 from 9 a.m. to 5 p.m. EST to discuss the treatment, a farnesoid X receptor (FXR) agonist already in the market for rare autoimmune disease primary biliary cholangitis.

In January, the FDA accepted the company’s New Drug Application (“NDA”) for OCA for liver fibrosis due to NASH, granting June 22, 2023, as the target action date. Intercept ( ICPT ) expected an AdCom meeting ahead of the decision.

The FDA's advisory committees issue non-binding recommendations. However, the regulator usually follows them before making a final decision on authorizations.

Read: Seeking Alpha contributor BioSci Capital Partners issued a Buy rating on Intercept ( ICPT ) in January expecting the stock to generate “several-fold returns.”

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