Smooth sailing for Madrigal as NASH candidate gets FDA priority review, no AdComm

Just days after a CEO shake-up, Madrigal Pharmaceuticals has shared that the FDA has given its nonalcoholic steatohepatitis (NASH) drug priority review and that the agency doesn’t plan on holding an advisory committee meeting.

Madrigal submitted a new drug application for the accelerated approval of resmetirom, its once-daily, oral candidate for patients with liver fibrosis and NASH, the most severe form of nonalcoholic fatty liver disease. The FDA has now said it will make a decision by March 14, 2024, and won't require an advisory committee meeting.

If given the green light, resmetirom could be the first treatment approved in the indication. Only four investigational treatments have even made it into phase 3 development for NASH, with resmetirom leading the pack.

Evercore analyst Liisa Bayko said the FDA's decision not to hold a committee meeting ahead of the approval decision was "somewhat unusual for … a disease like NASH which has yet to have an approved drug." Analysts are viewing this move as "an incremental derisking event suggesting that FDA has all the elements it needs to complete the review," Bayko added in a note this morning.

The news comes just two days after Madrigal’s former CEO Paul Friedman, M.D., stepped down so Bill Sibold could take up the helm as the company gears up to become a commercial organization. 

Sibold joins the Pennsylvania-based biotech after 12 years with Sanofi, where he most recently served as executive vice president of specialty care and president of North American operations.  

Madrigal's stock, which dipped slightly after the CEO change-up, has rebounded this morning, rising from $177 yesterday at market close to $189 per share as of 10:30 a.m. ET Wednesday.