Latest news with #MDGL
Reuters
20-06-2025
- Health
- Reuters
EU medicines regulator grants conditional authorisation for Madrigal's liver disease drug
June 20 (Reuters) - The European Union's medicines regulator on Friday granted a conditional authorisation for Madrigal Pharmaceuticals' (MDGL.O), opens new tab drug for a type of fatty liver disease, paving the way to make it the first treatment available for the condition in the region. The drug, sold as Rezdiffra, was first approved in the United States in March last year. The disease known as non-alcoholic steatohepatitis (NASH), or more recently renamed as metabolic dysfunction-associated steatohepatitis (MASH), causes excess build up of fat in the liver, resulting in inflammation and fibrosis, or scarring, of the organ.
Business Insider
11-05-2025
- Health
- Business Insider
Madrigal announces two-year results from Phase 3 MAESTRO-NAFLD-1 trial
Madrigal Pharmaceuticals (MDGL) announced positive two-year results from the open-label compensated MASH cirrhosis arm of the Phase 3 MAESTRO-NAFLD-1 trial of Rezdiffra. Patients 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. Among patients with CSPH at baseline, 65% moved into lower risk categories by year two. 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 and the Enhanced Liver Fibrosis test as additional evidence for CSPH risk. 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. Protect Your Portfolio Against Market Uncertainty
Yahoo
02-05-2025
- Business
- Yahoo
Madrigal Pharmaceuticals Inc (MDGL) Q1 2025 Earnings Call Highlights: Strong Sales Growth and ...
Net Sales: $137.3 million in Q1 2025, up 33% from Q4 2024. Patient Growth: Over 17,000 patients on Rezdiffra by end of Q1 2025, up from 11,800 in Q4 2024. Prescriber Penetration: 70% of 6,000 top target prescribers have prescribed Rezdiffra. R&D Expenses: $44.2 million in Q1 2025, down from $71.2 million in Q1 2024. SG&A Expenses: $167.9 million in Q1 2025, up from $80.8 million in Q1 2024. Cash Position: $848.1 million in cash, cash equivalents, restricted cash, and marketable securities at the end of Q1 2025. Warning! GuruFocus has detected 5 Warning Signs with MDGL. Release Date: May 01, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Madrigal Pharmaceuticals Inc (NASDAQ:MDGL) reported strong first quarter 2025 net sales of $137 million, up 33% quarter over quarter. Rezdiffra, the first FDA-approved treatment for MASH, achieved over 80% commercial payer coverage and treated more than 17,000 patients in its first year. The company has successfully built a strong base of prescribers, with 70% of their top 6,000 targets having prescribed Rezdiffra. Madrigal Pharmaceuticals Inc (NASDAQ:MDGL) is expanding its leadership in MASH with compelling two-year F4c data and ongoing pivotal outcomes trials. The company is well-positioned financially, ending the first quarter with $848.1 million in cash and marketable securities, supporting ongoing and future launches. SG&A expenses increased significantly to $167.9 million in Q1 2025, up from $80.8 million in Q1 2024, primarily due to commercial launch activities. The company anticipates gross-to-net discounts to increase throughout 2025 as they begin contracting with payers. There is uncertainty regarding the impact of potential competition from semaglutide (SEMA) once it gains label expansion for NASH. The European launch of Rezdiffra faces challenges, including responding to regulatory questions and potential differences in non-invasive testing acceptance compared to the FDA. Madrigal Pharmaceuticals Inc (NASDAQ:MDGL) is actively seeking business development opportunities, which may impact cash flow and require careful financial management. Q: Can you elaborate on your expectations for Rezdiffra's growth trajectory, especially with the potential label expansion of SEMA to include NASH? A: We are very excited about our growth momentum and expect it to continue. Our focus has been on the 315,000 diagnosed F2/F3 MASH patients, with only 5% currently treated with Rezdiffra. We anticipate years of growth ahead, and SEMA's approval could further expand the market. We believe our product profile will allow us to grow through any potential market changes. Q: What are your expectations around payer reauthorization requirements and patient persistency on Rezdiffra beyond the first year? A: Reauthorizations are standard and typically require a 12-month re-off. We are not concerned as we are receiving positive feedback from physicians and patients about the drug's efficacy. We expect persistency to be strong due to Rezdiffra's well-tolerated nature and the positive real-world experience. Q: Can you provide an update on the European approval process for Rezdiffra and how non-invasive testing is being approached differently than in the US? A: We are on track for a mid-year action in Europe. The questions from the CHMP are expected, and we are pleased with the review process. Europe is ahead of the US in terms of guidelines and preparation for a MASH product, and we believe there are enough installed NITs to support our launch effectively. Q: What is your confidence in showing an OUTCOMES benefit on hepatic events in F2, F3, versus F4 patients? A: We are confident in our mechanism of action as a liver-directed therapy. Our data shows a significant reduction in liver stiffness, which is a key predictor of adverse liver-related events. We believe this will translate into positive outcomes in our ongoing F4c trial. Q: Can you discuss the impact of your DTC campaign on the launch trajectory and your business development strategy moving forward? A: Our DTC campaign has received positive feedback, helping educate patients and prepare them for discussions with their providers. For business development, we aim to extend our leadership in MASH by exploring complementary assets that could enhance Rezdiffra's efficacy or address different patient segments. We will maintain financial discipline in our approach. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
Yahoo
01-05-2025
- Business
- Yahoo
Madrigal: Q1 Earnings Snapshot
WEST CONSHOHOCKEN, Pa. (AP) — WEST CONSHOHOCKEN, Pa. (AP) — Madrigal Pharmaceuticals Inc. (MDGL) on Thursday reported a loss of $73.2 million in its first quarter. On a per-share basis, the West Conshohocken, Pennsylvania-based company said it had a loss of $3.32. The results surpassed Wall Street expectations. The average estimate of eight analysts surveyed by Zacks Investment Research was for a loss of $3.62 per share. The biopharmaceutical company posted revenue of $137.3 million in the period, which also beat Street forecasts. Six analysts surveyed by Zacks expected $114 million. _____ This story was generated by Automated Insights ( using data from Zacks Investment Research. Access a Zacks stock report on MDGL at Sign in to access your portfolio
