Madrigal Pharmac Stock Price, News & Analysis

Madrigal Pharmaceuticals (NASDAQ: MDGL) has announced a delay in releasing the topline 52-week results of the MAESTRO-NAFLD-1 study, now expected in January 2022, due to unforeseen staffing issues at the data analysis vendor. This Phase 3 study evaluates resmetirom in patients with non-alcoholic fatty liver disease, presumed NASH. Enrollment for the study was completed in November 2020 with over 1,200 patients. The company continues its Phase 3 trials, aiming for a potential Subpart H submission to the FDA for accelerated approval of resmetirom.

Madrigal Pharmaceuticals (NASDAQ: MDGL) has announced participation in two upcoming virtual investor conferences. Management will hold a fireside chat at the Evercore ISI 4th Annual HealthCONx Conference on November 30, 2021, at 9:40 AM EST, and at the Piper Sandler 33rd Annual Virtual Healthcare Conference on December 2, 2021, at 11:30 AM EST. The presentations will be webcast live and archived for 90 days on the Madrigal website. The company is focused on developing therapies for cardio-metabolic diseases, particularly NASH, with its lead candidate resmetirom currently in Phase 3 studies.

Madrigal Pharmaceuticals (MDGL) presented positive findings from the 52-week open-label study of resmetirom at the AASLD 2021. The study included 171 patients with presumed NASH and fibrosis. Key results showed:

• Significant reductions in liver fat and volume.
• Improvements in liver fibrosis, measured by biomarkers and imaging.
• Reduction in atherogenic lipids and liver enzymes.
• Resmetirom was well-tolerated with no safety concerns.

The ongoing Phase 3 MAESTRO-NAFLD-1 study aims to further evaluate resmetirom's efficacy.

Madrigal Pharmaceuticals (NASDAQ:MDGL) reported its Q3 2021 financial results, highlighting progress in its Phase 3 MAESTRO-NASH and MAESTRO-NAFLD-1 studies. The company's cash and marketable securities increased to $299.1 million, aided by $151.2 million from stock sales. Operating expenses rose to $63.2 million, reflecting higher R&D costs related to clinical trials, totaling $54.9 million for Q3. The company will present data from the MAESTRO-NAFLD-1 study at the AASLD’s upcoming meeting, slated for November 12-15, 2021.

Madrigal Pharmaceuticals (NASDAQ:MDGL) collaborates with the Fatty Liver Foundation to recognize Liver Awareness Month by ringing the Nasdaq closing bell, aiming to highlight the critical need for NAFLD/NASH awareness. NAFLD affects over 16 million Americans, with NASH being the leading cause of liver transplants. Madrigal supports the NAFLD Screening Fund to promote evidence-based screening for early detection of these conditions. The initiative is intended to enhance understanding and diagnosis of NAFLD/NASH, as well as guide affected patients to necessary care.

Madrigal Pharmaceuticals (NASDAQ:MDGL) announced its Q2 2021 financial results, highlighting significant advancements in its MAESTRO clinical trials for NASH treatment, including successful patient enrollment for accelerated approval. The company has over 2,000 patients enrolled across these trials, with promising results in liver fat reduction. As of June 30, 2021, Madrigal reported cash and marketable securities totaling $323.8 million, up from $284.1 million at year-end 2020. Operating expenses increased due to heightened R&D efforts, amounting to $61.7 million for the quarter.

Madrigal Pharmaceuticals has appointed Dr. Robert Waltermire as Chief Pharmaceutical Development Officer. With over 30 years of experience in pharmaceutical development, he will lead CMC development for resmetirom, Madrigal's lead candidate for treating NASH. This product is in two Phase 3 clinical studies aimed at addressing significant unmet medical needs. Dr. Waltermire's prior roles include Senior VP at VenatoRx and VP at Bristol-Myers Squibb, underscoring his extensive expertise. The company aims to achieve first-to-market status in the NASH treatment arena, potentially benefiting millions of patients.

Madrigal Pharmaceuticals (NASDAQ: MDGL) has dosed its first patient in the MAESTRO-NAFLD-1 Open Label Extension (NCT04951219), following the completion of the MAESTRO-NAFLD-1 Phase 3 study. This 52-week study evaluates the efficacy of resmetirom in addressing non-alcoholic fatty liver disease (NAFLD), presumed non-alcoholic steatohepatitis (NASH). Patients previously on placebo can now receive active treatment, while those on resmetirom continue. Positive results have been reported from prior trials, strengthening prospects for future treatment success and additional data on safety and efficacy.

Madrigal Pharmaceuticals (NASDAQ: MDGL) announced the achievement of planned target enrollment in its Phase 3 trial, MAESTRO-NASH, aimed at treating NASH with its lead candidate, resmetirom. The company plans to submit for Subpart H (Accelerated Approval) to the FDA, supported by data from MAESTRO-NASH and MAESTRO-NAFLD-1, which collectively involve over 2,000 patients. Topline data is expected by Q3 2022. The studies highlight the significant unmet medical need for NASH therapies.