공시 • May 10

Madrigal Announces New Clinical Data Demonstrating Rezdiffra™ (Resmetirom) Significantly Improved Multiple Noninvasive Tests and Portal Hypertension Risk in Patients with Compensated Mash Cirrhosis

Madrigal Pharmaceuticals, Inc. announced positive two-year results from the open-label compensated MASH cirrhosis (F4c) arm of the Phase 3 MAESTRO-NAFLD-1 trial of Rezdiffra. Patients (n=122) in the study achieved significant improvements from baseline in liver stiffness, liver fat, fibrosis biomarkers, liver volume and risk scores for clinically significant portal hypertension (CSPH). CSPH is a major consequence of cirrhosis and is responsible for its most severe complications, including ascites, variceal bleeding and hepatic encephalopathy. Patients with MASH who progress to cirrhosis face a 42 times higher risk of liver-related mortality.MAESTRO-NAFLD-1 included an open-label active treatment arm of patients with compensated MASH cirrhosis. After one year, patients were given the option to enroll in an open-label extension trial; 122 patients enrolled and 113 completed two years of treatment. At baseline, 35% of patients met Baveno criteria for CSPH, 14% for probable CSPH and 51% for no/low CSPH. The Baveno criteria use a combination of vibration-controlled transient elastography (VCTE) and platelet count to assess CSPH risk.Among patients with CSPH at baseline, 65% moved into lower risk categories by year two (42% to no/low CSPH and 23% to probable CSPH). Among patients with probable CSPH at baseline, 57% moved into the no/low CSPH category as compared to 14% who moved into the CSPH category by year two. Improvement in CSPH risk was statistically significant compared to baseline. Similar shifts to lower risk categories were observed in an analysis using a more stringent modified Baveno criteria that incorporates magnetic resonance elastography (MRE) and the Enhanced Liver Fibrosis (ELF) test as additional evidence for CSPH risk. As previously reported, patients achieved a mean 6.7 kPa reduction in liver stiffness at two years, which was statistically significant compared to baseline. In a responder analysis examining =25% improvement or worsening of liver stiffness, 51% of patients achieved improvement. An improvement of this magnitude has been associated with reduced progression to end-stage liver disease. Rezdiffra helped 35% of patients achieve liver stiffness measurements consistent with F3 fibrosis, suggesting reversal of cirrhosis.Safety data were consistent with previous studies and Rezdiffra was well-tolerated with a low rate of discontinuation due to adverse events. The most common adverse events were diarrhea, COVID-19 and nausea. There were two deaths unrelated to Rezdiffra.

공시 • Jun 08

Madrigal Pharmaceuticals, Inc. Announces New Data from the Phase 3 MAESTRO-NASH Study of Rezdiffra (resmetirom) Presented at the EASL Congress

Madrigal Pharmaceuticals, Inc. announced results from new analyses of the Phase 3 MAESTRO-NASH trial of Rezdiffra being presented at the EASL Congress, which takes place from June 5-8, 2024 in Milan, Italy. Rezdiffra is a once-daily, oral, liver-directed thyroid hormone receptor (THR)-ß agonist designed to target key underlying causes of NASH. It is the first approved medication for the treatment of NASH. In the pivotal Phase 3 MAESTRO-NASH biopsy trial, Rezdiffra achieved both fibrosis improvement and NASH resolution primary endpoints, and 80% of patients treated with Rezdiffra 100 mg experienced improvement or stabilization of fibrosis. Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials. An AI-driven fibrosis assessment methodology, qFibrosis (Histoindex), has identified 30 specific fibrotic features on NASH liver biopsies that may be predictive of progression to cirrhosis and decompensated cirrhosis based on the SteatoSITE database. SteatoSITE contains integrated clinical and pathological data from 940 cases across the NASH spectrum with outcome data from electronic health record and pathologist-assigned fibrosis stage and RNA on baseline biopsy. In an analysis of MAESTRO-NASH data featured in a late-breaking presentation at EASL, total qFibrosis score showed a highly significant improvement in fibrosis with Rezdiffra treatment and less progression of fibrosis as compared with placebo; results were similar to pathologist scoring. Six qFibrosis progression features with the strongest correlations between baseline pathologist scoring and noninvasive tests were identified. At week 52, patients treated with Rezdiffra showed reduction from baseline in these key features compared to placebo, with the most marked reductions occurring in the F3 population. In analyses of noninvasive test results from MAESTRO-NASH, changes in vibration-controlled transient elastography (VCTE; an ultrasound-based measure of liver stiffness, a surrogate for fibrosis), controlled attenuation parameter (CAP; an ultrasound-derived measure of fat content in the liver), and magnetic resonance imaging-proton density fat fraction (MRI-PDFF; an MRI-based measure of triglyceride content in the liver) were assessed in the Rezdiffra 80mg, Rezdiffra 100mg, and placebo groups. Liver stiffness as measured by VCTE improved over time (up to three years) relative to placebo in Rezdiffra-treated patients, with both doses showing a similar durable response. At year three, 91% of patients treated with Rezdiffra had improved or stable liver stiffness, as compared to 9% who experienced a =30% increase in liver stiffness. CAP improvement was also stable over time, with both Rezdiffra doses showing a similar durable response through three years of treatment. CAP and MRI-PDFF improvements in patients treated with Rezdiffra predicted achieving both fibrosis improvement and NASH resolution responses on histology. However, CAP and MRI-PDFF improvements in placebo-treated patients did not predict fibrosis improvement, highlighting the importance of reducing liver fat directly in hepatocytes through THR-ß agonism. In the first analysis of health-related quality of life (HRQL) data from patients participating in the MAESTRO-NASH trial, changes in HRQL scores from baseline were evaluated in patients receiving Rezdiffra versus placebo and compared between patients with versus without biopsy response. By weeks 24 and 52, patients receiving both doses of Rezdiffra experienced improvement of HRQL scores in the Worry domain of the Chronic Liver Disease Questionnaire-NASH. At week 52, Rezdiffra-treated patients who achieved fibrosis improvement or NASH resolution experienced improvement in several HRQL domains, including domains for Worry, Health Distress and Stigma. The improvement in HRQL among Rezdiffra biopsy responders was contrasted by no similar improvement in the placebo group. Biopsy responders with stage F3 fibrosis at baseline had similar or more pronounced improvements of HRQL in comparison to those responders with F2 or F1B fibrosis at baseline. The first analysis of Rezdiffra treatment in MetALD included 75 patients from the Phase 3 MAESTRO-NASH study who were believed to have significant alcohol consumption in addition to NASH. Patients with probable MetALD were identified based on Carbohydrate Deficient Transferrin (CDT), a biomarker for chronic alcohol consumption, collected longitudinally through the study, and phosphatidylethanol (PEth) tests performed in patients suspected of increased alcohol consumption. Rezdiffra-treated patients in the MetALD group achieved rates of fibrosis improvement and steatohepatitis resolution that were similar to the positive results observed in the overall MAESTRO-NASH population and to patients with NASH with low alcohol consumption. In the MetALD group, 88% of patients treated with Rezdiffra 100 mg and 81% treated with Rezdiffra 80 mg showed a =30% reduction from baseline in MRI-PDFF, compared to 14% in the placebo group. MAESTRO-NASH is an ongoing Phase 3 trial that enrolled 1759 patients with biopsy-confirmed NASH. Patients were randomly assigned in a 1:1:1 ratio to receive once-daily Rezdiffra at a dose of 80 mg or 100 mg or placebo. The two primary endpoints at week 52 were NASH resolution with no worsening of fibrosis and an improvement in fibrosis by at least one stage with no worsening of the NAFLD activity score. The key secondary endpoint was the percent change from baseline in LDL cholesterol at week 24. Patients enrolled in the MAESTRO-NASH trial continue on therapy after the initial 52-week treatment period for up to 54 months to accrue and measure hepatic clinical outcome events including progression to cirrhosis on biopsy and hepatic decompensation events, as well as all-cause mortality. The 54-month outcomes portion of the trial is designed to generate confirmatory data that, if positive, will help verify Rezdiffra’s clinical benefit and may support full approval.

총 주주 수익률	-0.3%
미래 배당 수익률	0%
배당 성장률	n/a
다음 배당 지급일	n/a
배당락일	n/a
주당 배당금	n/a
배당 성향	n/a

구분	배당 수익률
회사 (MDGL)	n/a
시장 하위 25% (US)	1.4%
시장 상위 25% (US)	4.3%
업계 평균 (Biotechs)	2.4%
분석가 예측 (MDGL) (최대 3년)	0%

데이터	최종 업데이트 (UTC 시간)
기업 분석	2026/05/21 10:34
종가	2026/05/21 00:00
수익	2026/03/31
연간 수익	2025/12/31

패키지	데이터	기간	미국 소스 예시 ^*
기업 재무제표	10년	손익계산서 현금흐름표 대차대조표	SEC 양식 10-K SEC 양식 10-Q
분석가 컨센서스 추정치	+3년	재무 예측 분석가 목표주가	분석가 리서치 보고서 Blue Matrix
시장 가격	30년	주가 배당, 분할 및 기타 조치	ICE 시장 데이터 SEC 양식 S-1
지분 구조	10년	주요 주주 내부자 거래	SEC 양식 4 SEC 양식 13D
경영진	10년	리더십 팀 이사회	SEC 양식 10-K SEC 양식 DEF 14A
주요 개발	10년	회사 공시	SEC 양식 8-K

분석가	기관
Eliana Merle	Barclays
Matthew Luchini	BMO Capital Markets Equity Research
Jason Zemansky	BofA Global Research

Madrigal Pharmaceuticals 배당 및 자사주 매입

배당 기준 점검 0/6

핵심 정보

최근 배당 및 자사주 매입 업데이트

Recent updates

MDGL: MASH Pool Assumptions Versus Gross To Net Execution Will Shape Outlook

Madrigal Pharmaceuticals Reports Revenue of US$311.3 Million as Rezdiffra Patient Base Grows

First quarter 2026 earnings: EPS and revenues exceed analyst expectations

Madrigal Pharmaceuticals, Inc., Annual General Meeting, Jun 17, 2026

Madrigal Pharmaceuticals: Boom Or Bust In MASH? Regretfully, I'm Bearish

MDGL: Gross To Net Execution And Margin Pressure Will Shape Balanced Outlook

Madrigal Pharmaceuticals, Inc. to Report Q1, 2026 Results on May 06, 2026

MDGL: Gross To Net Execution And Cirrhosis Expansion Will Shape Balanced Outlook

MDGL: MASH Combinations And Cirrhosis Expansion Will Shape Balanced Future Outlook

MDGL: Cirrhosis Expansion And MASH Combinations Will Drive Future Repricing

Executive VP & CFO notifies of intention to sell stock

Executive VP & CFO recently sold US$505k worth of stock

MDGL: MASH Franchise And DGAT2 Combo Plans Will Drive Future Upside

Full year 2025 earnings: EPS misses analyst expectations

MDGL: Future Leadership Will Rely On MASH Cirrhosis Uptake Versus GLP 1 Pressure

Forecast breakeven date pushed back to 2027

Forecast breakeven date pushed back to 2027

Madrigal Pharmaceuticals, Inc. to Report Q4, 2025 Results on Feb 19, 2026

MDGL: MASH Franchise Expansion And New DGAT2 Combo Study Will Drive Upside

Price target increased by 7.3% to US$657

Founder recently sold US$1.1m worth of stock

MDGL: Cirrhosis Expansion And Combination Plans Will Test High Expectations

Director exercised options and sold US$13m worth of stock

MDGL: Elevated Expectations For Cirrhosis Opportunity Will Face Heightened Competitive Pressures

MDGL: Future Leadership Will Depend On Cirrhosis Uptake Amid GLP 1 Competition

Price target increased by 7.0% to US$603

Madrigal Pharmaceuticals, Inc. Appoints Rita Thakkar as Senior Vice President and Chief Accounting Officer, Effective January 12, 2026

MDGL: Future Leadership Will Depend On Expanding MASH Cirrhosis And Fibrosis Therapy Adoption

Executive VP & CFO exercised options and sold US$1.4m worth of stock

MDGL: Future Leadership Will Depend On Expanding Liver Fibrosis Therapy Penetration Amid Competition

Forecast to breakeven in 2026

Madrigal Pharmaceuticals, Inc.'s (NASDAQ:MDGL) 26% Price Boost Is Out Of Tune With Revenues

Madrigal Pharmaceuticals, Inc. Presents New Data Demonstrating Rezdiffra®? (Resmetirom) Significantly Improved Multiple Noninvasive Imaging Tests and Biomarkers in Patients with Compensated Mash Cirrhosis

MDGL: Future Revenue Leadership Will Depend On Therapy Adoption Amid Rising Competition

Independent Director notifies of intention to sell stock

Third quarter 2025 earnings: Revenues exceed analysts expectations while EPS lags behind

Price target increased by 7.3% to US$525

Madrigal Pharmaceuticals, Inc. to Present New Data from the Company's MASH Program at AASLD's The Liver Meeting 2025

EU Expansion and Combination Therapies Will Drive Future Opportunity

Madrigal Pharmaceuticals, Inc. to Report Q3, 2025 Results on Nov 04, 2025

US Patent And EU Expansion Will Secure Future Potential

US Patent And EU Expansion Will Secure Future Potential

CEO, President & Director recently sold US$3.2m worth of stock

US Patent And EU Expansion Will Secure Future Potential

High number of new directors

US Patent And EU Expansion Will Secure Future Potential

Madrigal Pharmaceuticals, Inc.'s (NASDAQ:MDGL) 30% Price Boost Is Out Of Tune With Revenues

Madrigal Pharmaceuticals, Inc. Receives European Commission Approval for Rezdiffra (resmetirom) for the Treatment of MASH with Moderate to Advanced Liver Fibrosis

Forecast: Analysts Think Madrigal Pharmaceuticals, Inc.'s (NASDAQ:MDGL) Business Prospects Have Improved Drastically

Consensus revenue estimates increase by 28%

Earnings Beat: Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) Just Beat Analyst Forecasts, And Analysts Have Been Lifting Their Forecasts

Madrigal Pharmaceuticals, Inc. to Report Q2, 2025 Results on Aug 05, 2025

Founder notifies of intention to sell stock

Madrigal Pharmaceuticals, Inc. Receives Positive Chmp Opinion for Resmetirom (Rezdiffra™?) for the Treatment of Mash with Moderate to Advanced Liver Fibrosis

Madrigal Announces New Clinical Data Demonstrating Rezdiffra™ (Resmetirom) Significantly Improved Multiple Noninvasive Tests and Portal Hypertension Risk in Patients with Compensated Mash Cirrhosis

FDA Approval Will Expand MASH Treatment Market Reach

Madrigal Pharmaceuticals, Inc., Annual General Meeting, Jun 20, 2025

Madrigal Pharmaceuticals, Inc. to Report Q1, 2025 Results on May 01, 2025

Madrigal Pharmaceuticals, Inc. Announces Management Changes

Independent Director exercised options to buy US$3.0m worth of stock.

Price target increased by 8.7% to US$414

Independent Lead Director exercised options and sold US$3.8m worth of stock

Insider exercised options and sold US$3.6m worth of stock

Madrigal Pharmaceuticals, Inc. Announces Board Changes

Insider recently sold US$418k worth of stock

Consensus revenue estimates increase by 13%

Independent Director notifies of intention to sell stock

Price target increased by 8.4% to US$413

Madrigal Pharmaceuticals, Inc. Announces New Two-Year Data from the Compensated MASH Cirrhosis Arm of the MAESTRO-NAFLD-1 Trial

Madrigal Pharmaceuticals Q4 Earnings Review: Strong Quarter, Even Stronger Outlook

Madrigal Pharmaceuticals, Inc. to Report Q4, 2024 Results on Feb 26, 2025

CEO, President & Director recently sold US$531k worth of stock

Madrigal Pharmaceuticals Rezdiffra Vies For Blockbuster Status In MASH

Founder recently sold US$462k worth of stock

New minor risk - Insider selling