Latest news with #MadrigalPharmaceuticalsInc
Yahoo
24-06-2025
- Business
- Yahoo
Madrigal Pharmaceuticals Closer to EU Approval for First MASH Treatment, Rezdiffra
Madrigal Pharmaceuticals Inc. (NASDAQ:MDGL) is one of the best biotech stocks to invest in now. On June 20, Madrigal Pharmaceuticals moved closer to introducing the first treatment for metabolic dysfunction-associated steatohepatitis/MASH in Europe. The European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion recommending the approval of Rezdiffra (resmetirom). Although the European Commission is not obligated to follow this recommendation, a final decision is anticipated in August 2025. Following this announcement, shares of Madrigal (MDGL) opened 0.5% higher on June 20. The Pennsylvania-headquartered company has a market capitalization of ~$6.3 billion and also has a therapy portfolio for cardiovascular and metabolic diseases. A scientist examining the results of a Phase III clinical trial for non-alcoholic steatohepatitis. Rezdiffra is already approved and available in the US for adults with noncirrhotic MASH who have moderate to advanced liver fibrosis. If approved in Europe, Rezdiffra would hold the same indication. Madrigal secured accelerated approval from the US FDA for Rezdiffra in March 2024, making it the first MASH treatment in the US market. MASH is a form of non-alcoholic fatty liver disease/NAFLD and is a significant health concern, being the leading cause of liver transplantation in women and the second leading cause of all liver transplantations in the US. Madrigal Pharmaceuticals Inc. (NASDAQ:MDGL) is a biopharmaceutical company that delivers novel therapeutics for metabolic dysfunction-associated steatohepatitis/MASH in the US. While we acknowledge the potential of MDGL as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey.
Yahoo
15-05-2025
- Business
- Yahoo
John Paulson's Strategic Move: Honeywell International Inc. Takes Center Stage
John Paulson (Trades, Portfolio) recently submitted the 13F filing for the first quarter of 2025, providing insights into his investment moves during this period. John Paulson (Trades, Portfolio) is the President and Portfolio Manager of Paulson & Co. Inc. Paulson was ranked by Absolute Return Magazine as the 3rd largest hedge fund in the world managing approximately $29 billion in merger, event, and distressed strategies. Mr. Paulson received his Masters of Business Administration with high distinction, as a Baker Scholar, from Harvard Business School in 1980. He graduated summa cum laude in Finance from New York University's College of Business and Public Administration in 1978. Prior to forming Paulson in 1994, John was a general partner of Gruss Partners and a managing director in mergers and acquisitions at Bear Stearns. John Paulson (Trades, Portfolio), a former mergers and acquisitions banker, established his firm as a merger arbitrage hedge fund manager, seeking to make money from situations when one public company announces plans to take over another. Merger arbitrage hedge funds primarily study equity markets, but they also research the market for credit default swaps, a form of insurance that starts paying out as soon as a credit security falls in value. Warning! GuruFocus has detected 4 Warning Signs with MDGL. John Paulson (Trades, Portfolio) added a total of 2 stocks, among them: The most significant addition was Honeywell International Inc (NASDAQ:HON), with 200,000 shares, accounting for 2.42% of the portfolio and a total value of $42.35 million. The second largest addition to the portfolio was Intra-Cellular Therapies Inc (ITCI), consisting of 21,500 shares, representing approximately 0.16% of the portfolio, with a total value of $2,836,280. John Paulson (Trades, Portfolio) also increased stakes in a total of 2 stocks, among them: The most notable increase was Madrigal Pharmaceuticals Inc (NASDAQ:MDGL), with an additional 57,523 shares, bringing the total to 2,099,523 shares. This adjustment represents a significant 2.82% increase in share count, a 1.09% impact on the current portfolio, with a total value of $695.425 million. The second largest increase was International Tower Hill Mines Ltd (THM), with an additional 6,040,408 shares, bringing the total to 70,239,388. This adjustment represents a significant 9.41% increase in share count, with a total value of $44,391,290. John Paulson (Trades, Portfolio) completely exited 1 of the holdings in the first quarter of 2025, as detailed below: Alphabet Inc (NASDAQ:GOOGL): John Paulson (Trades, Portfolio) sold all 10,000 shares, resulting in a -0.12% impact on the portfolio. At the first quarter of 2025, John Paulson (Trades, Portfolio)'s portfolio included 14 stocks, with top holdings including 39.81% in Madrigal Pharmaceuticals Inc (NASDAQ:MDGL), 15.16% in Perpetua Resources Corp (NASDAQ:PPTA), 13.25% in Acadian Asset Management Inc (NYSE:AAMI), 9.79% in Bausch Health Companies Inc (NYSE:BHC), and 4.86% in Agnico Eagle Mines Ltd (NYSE:AEM). The holdings are mainly concentrated in 5 of all the 11 industries: Healthcare, Basic Materials, Financial Services, Communication Services, and Industrials. This article, generated by GuruFocus, is designed to provide general insights and is not tailored financial advice. Our commentary is rooted in historical data and analyst projections, utilizing an impartial methodology, and is not intended to serve as specific investment guidance. It does not formulate a recommendation to purchase or divest any stock and does not consider individual investment objectives or financial circumstances. Our objective is to deliver long-term, fundamental data-driven analysis. Be aware that our analysis might not incorporate the most recent, price-sensitive company announcements or qualitative information. GuruFocus holds no position in the stocks mentioned herein. This article first appeared on GuruFocus. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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
