Earlier today, Madrigal Pharma (NASDAQ: MDGL) announced delay in release of Topline results from the Phase 3 MAESTRO-NAFLD-1 trial of Resmetirom.

Commenting on the announcement, H. C. Wainwright analyst Ed Arce sees no issue with the four-week pushback: "MAESTRO-NAFLD-1's 52-week top-line data readout is pushed back by four weeks at most. This morning, Madrigal announced that it now plans to report top-line data from the Phase 3 MAESTRO-NAFLD-1 study of resmetirom in patients with NAFLD and presumed NASH in January 2022, delayed from the previous target of yearend 2021, due to unexpected staffing issues at the external vendor responsible for the analyses of MRI-PDFF and lipid data. While we had anticipated MAESTRO-NAFLD-1's top-line data readout by year-end 2021 to be Madrigal's key near-term catalyst, management noted that the study's blinded data package was delivered to the vendor on time, and we see no negative read-through to the study’s results from this slight delay of four weeks at most. As a reminder, MAESTRO-NAFLD-1 (NCT04197479) is a 52-week double-blind, placebo-controlled, randomized Phase 3 trial that enrolled more than 1,200 patients with biopsy-confirmed or presumed NASH (F<3). Enrolled patients are randomized 1:1:1 to receive a single daily oral dose of either resmetirom 80 mg, resmetirom 100 mg, or placebo. The primary endpoint of MAESTRO-NAFLD-1 evaluates resmetirom's adverse event (AE) profile, with secondary efficacy endpoints including measurements in LDL-cholesterol, apolipoprotein B, triglyceride, liver fat content as evaluated by MRI-PDFF, and PRO-C3. We continue to regard MAESTRO-NAFLD-1's top-line data readout as the next de-risking event for resmetirom, and point to the positive data from the study's open-label cohort as an early read-through to resmetirom's efficacy in this patient population. Importantly, we remain focused on the topline readout of the pivotal Phase 3 MAESTRO-NASH study, expected in 3Q22. Please see our report published on November 19, 2021, Post-AASLD KOL Event Highlights Both Strong Non-Invasive Data and Increasing NIT Correlations to Histology Endpoints, for our full analysis of the MAESTRO-NAFLD-1 study's most recent dataset reported in November 2021. Affirm Buy. "

H. C. Wainwright reiterates a "Buy" rating with $170 price target.

MDGL is moving nearly 4% higher in midday trading.

Written by Vlad Schepkov | [email protected]