Madrigal Pharmaceuticals

Madrigal Pharmaceuticals, Inc. engages on the development and commercialization of innovative therapeutic candidates for the treatment of cardiovascular, metabolic, and liver diseases. Its lead product, MGL-3196, is used for the treatment of non-alcoholic steatohepatitis and familial hypercholesterolemia. The company was founded by Rebecca Taub and Edward Chiang on September 2011 and is headquartered in Fort Washington, PA.

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Madrigal Pharmaceuticals gains FDA approval for NASH medicine Rezdiffra

Madrigal Pharmaceuticals achieved FDA approval for Rezdiffra, focusing on market leadership and patient services.
Sales expected to be back-end loaded in 2024, with varying prescription dynamics and affordability considerations.
Company confident in revenue consensus but hasn't provided specific numbers, creating uncertainty for investors.
Emphasis on high unmet need, early positive feedback, and comprehensive patient support services.

Madrigal Pharmaceuticals excels in Q2 with Rezdiffra launch success

Madrigal Pharmaceuticals demonstrated strong financial performance and market acceptance of Rezdiffra in Q2 2024.
The company faces challenges in educating stakeholders and managing operational aspects of expansion.
Opportunities lie in global expansion, new market segments, and continued growth in sales and brand recognition.

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Madrigal Pharmaceuticals, Inc. engages in the development and commercialization of innovative therapeutic candidates for the treatment of cardiovascular, metabolic, and liver diseases. Its lead product, MGL-3196, is used for the treatment of non-alcoholic steatohepatitis and familial hypercholesterolemia. The company was founded by Rebecca Taub and Edward Chiang on March 2000 and is headquartered in West Conshohocken, PA.

Madrigal Pharmaceuticals is going after a market with a large unmet need. The company's leading candidate, resmetirom, looks very promising.

1 Beaten-Down Stock That Could Soar by 86%, According to Wall Street

Madrigal (MDGL) gains as new drug application for resmeritom to treat nonalcoholic steatohepatitis gets accepted by the FDA in the United States.

Madrigal (MDGL) Gains on NDA for NASH Therapy Acceptance by FDA

Madrigal said Wednesday it could win FDA approval for its nonalcoholic steatohepatitis treatment in March, and MDGL stock jumped.

Madrigal Pharmaceuticals Surges As Its NASH Treatment Toes The Long-Awaited Finish Line

CONSHOHOCKEN, Pa., Sept. 13, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for resmetirom for the treatment of adult patients with NASH with liver fibrosis. The FDA has granted Priority Review and assigned a Prescription Drug User Fee Act date for resmetirom of March 14, 2024, the target date by which the FDA intends to complete its review and take action on the NDA. The Agency noted that it is not currently planning to hold an advisory committee meeting to discuss the application.

Madrigal Pharmaceuticals Announces NDA Acceptance and Priority Review of the New Drug Application for Resmetirom for the Treatment of NASH with Liver Fibrosis

Shares of Madrigal Pharmaceuticals Inc. MDGL, +2.91% fell more than 7% premarket on Monday after the company appointed Bill Sibold, a former Sanofi SNY, +1.06% executive, as its new CEO. Sibold succeeds Dr. Paul Friedman, the company's CEO since 2016, who will continue to serve on the board of directors, Madrigal said in a release.

Madrigal Pharmaceuticals shares fall after new CEO named

CONSHOHOCKEN, Pa., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced that Bill Sibold has succeeded Paul Friedman, M.D., as Chief Executive Officer (CEO) and joined Madrigal's Board of Directors. Dr. Friedman, who has served as Madrigal's CEO since 2016, will continue to serve on the Board of Directors.

Madrigal Pharmaceuticals Appoints Bill Sibold as Chief Executive Officer

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Many drug developers are pursuing therapies for those who supper from NASH. Madrigal Pharmaceuticals is waiting on the FDA's decision for its drug right now.

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Madrigal Pharmaceuticals is developing resmetirom, a drug for non-alcoholic steatohepatitis and fatty liver disease, with promising trial results. Madrigal has a strong cash position and manageable debt, but faces rising R&D costs and competition in the NASH therapeutics field. My recommendation remains a "Buy" for risk-tolerant investors, despite concerns about weight loss drugs reducing NASH market potential.

Madrigal's Resmetirom Nears Commercialization Despite Market Concerns

CONSHOHOCKEN, Pa., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today provides a summary of recent corporate accomplishments and reports second quarter 2023 financial results.

Madrigal Pharmaceuticals Provides Corporate Updates and Reports Second Quarter 2023 Financial Results

CONSHOHOCKEN, Pa., July 17, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), announced the completion of the rolling submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for resmetirom for the treatment of adults with NASH with liver fibrosis, a disease with no approved therapy. Madrigal has requested a priority review of the resmetirom NDA.

Madrigal Pharmaceuticals Completes Submission of New Drug Application Seeking Accelerated Approval of Resmetirom for the Treatment of NASH with Liver Fibrosis

Madrigal Pharmaceuticals, Inc. dual surrogate Primary endpoint being met in phase 3 MAESTRO-NASH study allowed for the rolling NDA submission of resmetirom for the treatment of patients with NASH. Potential for rolling NDA submission of resmetirom to be granted Priority Review Status, which would cut review time from 10 months to 6 months. The phase 3 MAESTRO-NASH-OUTCOMES study would not only grant Accelerated Approval of resmetirom to full approval, but may also allow the possibility of obtaining full approval of well-compensated NASH cirrhosis.

Madrigal: With Successful NASH Study, Possible Accelerated Approval Is Next

Madrigal Pharmaceuticals Inc.'s stock MDGL, +5.00% rose 5% Friday after the company said it has started a rolling submission of a New Drug Application to the U.S. Food and Drug Administration seeking accelerated approval of its resmetirom as a treatment for, nonalcoholic steatohepatitis, or NASH, with liver fibrosis. NASH is a more severe version of nonalcoholic fatty liver disease, or NAFLD, a range of conditions that occurs when excess fat builds up in liver cells.

Madrigal Pharmaceuticals' stock up 5% as company starts rolling submission for FDA approval of NASH treatment

Madrigal said Friday it plans to finish submitting its application for approval of a NASH treatment in July, and MDGL stock popped.

Madrigal Stock Pops As It Makes Inroads Into What Could Be A $160 Billion Market

CONSHOHOCKEN, Pa., June 30, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval of resmetirom for the treatment of NASH with liver fibrosis. Madrigal has submitted the majority of the NDA to the FDA and plans to submit the remaining components in July 2023. The company will request a priority review of the NDA.

Madrigal Pharmaceuticals Announces Rolling Submission of New Drug Application to U.S. FDA Seeking Accelerated Approval of Resmetirom for the Treatment of NASH with Liver Fibrosis

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CONSHOHOCKEN, Pa., June 22, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today presents resmetirom Phase 3 MAESTRO-NASH data at the opening general session of the European Association for the Study of the Liver Congress (EASL 2023).

Madrigal Pharmaceuticals Presents Phase 3 MAESTRO-NASH Data During the Opening General Session of the EASL Congress™

Company expands support for NASH disease education through patient advocacy partnerships and a new digital campaign for patients with at-risk NASH Company expands support for NASH disease education through patient advocacy partnerships and a new digital campaign for patients with at-risk NASH

Madrigal Pharmaceuticals Supports International NASH Day on June 8

CONSHOHOCKEN, Pa., June 01, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), announced today its management team will participate in fireside chats at two upcoming investor conferences:

Madrigal Pharmaceuticals Announces Participation at Two Upcoming Investor Conferences

Madrigal Pharmaceuticals' drug, resmetirom, for non-alcoholic fatty liver diseases, received FDA's Breakthrough Therapy designation. The company is now focused on the MAESTRO-NASH-OUTCOMES trial. Madrigal's Q1 2023 financial reports show a decrease in cash holdings, and an increase in operating and R&D costs due to Phase 3 trials and workforce expansion. Competitor Intercept Pharmaceuticals faced a setback for its NASH drug, obeticholic acid, emphasizing the FDA's stringent safety and efficacy standards for NASH treatments.

Madrigal: Setting The Pace In The NASH Market (Rating Upgrade)

The shares are continuing a yearlong winning streak today. This latest uptick appears to be the result of two tailwinds.

Why Madrigal Pharmaceuticals Stock Is Marching Higher Today

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News for Madrigal Pharmaceuticals Stock (MDGL)