Key Takeaways MDGL rose 10.9% as a new U.S. patent is set to protect Rezdiffra's FDA-approved dosing regimen. The patent, valid through 2044, will be listed in the FDA's Orange Book, blocking generic competition. Over 17,000 patients are already on Rezdiffra as MDGL expands clinical data to support full approval.Madrigal Pharmaceuticals (MDGL) shares soared 10.9% on Wednesday. The uptrend was observed after the U.S. Patent and Trademark Office issued a Notice of Allowance for a new U.S. patent related to ...

Madrigal (MDGL) shares rallied 10.9% in the last trading session to close at $344.97. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 11.3% gain over the past four weeks.The sudden soaring of the stock price was observed after Madrigal received a Notice of Allowance for a new U.S. patent protecting the FDA-approved weight-based dosing regimen of Rezdiffra, its sole marketed drug for noncirrhotic metabolic dys ...

CONSHOHOCKEN, Pa., July 16, 2025 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction- associated steatohepatitis (MASH), today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance covering the FDA-approved use of Rezdiffra™ (resmetirom), the first and only FDA-approved treatment for adults with noncirrhotic MASH (also known as NASH) with moderate to a ...

Core Viewpoint - Madrigal Pharmaceuticals has received a positive opinion from the CHMP of the EMA recommending approval of resmetirom (Rezdiffra) for treating adults with noncirrhotic MASH with moderate to advanced liver fibrosis, with a decision from the European Commission expected in August 2025 [1][2][7] Company Overview - Madrigal Pharmaceuticals is focused on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease with high unmet medical need [16] - Resmetirom is the first approved medication for MASH in the U.S. and is designed as a once-daily, oral, liver-directed THR-β agonist [7][16] Product Details - Resmetirom has shown positive results in the pivotal Phase 3 MAESTRO-NASH trial, achieving both fibrosis improvement and MASH resolution primary endpoints [2][8] - In the U.S., resmetirom is indicated for adults with noncirrhotic MASH with moderate to advanced liver fibrosis (stages F2 to F3) in conjunction with diet and exercise [8][10] Industry Context - MASH is a leading cause of liver-related mortality and is the fastest-growing indication for liver transplantation in Europe [4][5] - The prevalence of MASH is expected to increase as awareness improves, leading to a growing number of diagnosed patients with moderate to advanced fibrosis or compensated MASH cirrhosis [6]

Company Overview - Madrigal Pharmaceuticals, Inc. is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need [3] - The company's medication, Rezdiffra (resmetirom), is the first and only FDA-approved treatment for MASH with moderate to advanced fibrosis [3] Equity Awards Announcement - On June 15, 2025, Madrigal granted equity awards to 36 new non-executive employees as part of its 2023 Inducement Plan [1] - The total equity awards included options to purchase 2,184 shares of common stock and 21,125 time-based restricted stock units [2] - The exercise price for the options is set at $295.57 per share, equal to the closing price on the grant date, with a vesting schedule that includes 25% vesting on the first anniversary and 6.25% vesting quarterly thereafter [2]

Financial Data and Key Metrics Changes - The launch of ResDiffera has been described as outstanding, with over 17,000 patients on the product by March 2025, compared to almost zero a year prior [6][7] - The company reported that over 80% of commercial lives were covered by payers at the six-month mark post-launch [6] - The company anticipates robust growth for 2025, with expectations for gross to net discounts typical for specialty medicines [44][45] Business Line Data and Key Metrics Changes - The company is focusing on expanding its prescriber base, with over 70% of targeted prescribers having written prescriptions for ResDiffera [9] - The company is currently at 5% penetration of the identified 315,000 diagnosed patients, indicating significant room for growth [8][9] - The management noted that the product is becoming standard of care, which is expected to facilitate further adoption [11] Market Data and Key Metrics Changes - The company sees favorable market dynamics in the NASH space, with a potential patient population that is many multiples of the diagnosed patients [8] - The anticipated approval of semaglutide is viewed as a market growth opportunity rather than a direct threat [31][32] Company Strategy and Development Direction - The company is optimistic about extending its intellectual property (IP) into the 2040s and is actively pursuing new IP to enhance its position [23][24] - The focus on lifecycle management includes ongoing trials and exploring distinct populations for potential new indications [24][26] - The company is strategically positioned to leverage its existing product while selectively pursuing business development opportunities [65][66] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the product's performance and its acceptance in the market, noting positive feedback from prescribers and patients [36][37] - The company is well-prepared for the European launch, with a strong team in place and high anticipation from the treating community [78][79] - Management believes that the competitive landscape will not hinder their growth, as they maintain a strong product profile [30][31] Other Important Information - The company has a strong balance sheet with $848 million in cash and only $115 million in debt, providing ample capacity for future initiatives [69] - The management emphasized the importance of time in building familiarity with the product among prescribers and patients [11] Q&A Session Summary Question: What are the expectations for reauthorization? - Management believes reauthorization will not be a challenge, as criteria are fair and based on physician assessments of patient stabilization or improvement [21][22] Question: How does the company plan to manage competition? - The company is focused on gross to net strategies and has begun contracting for access, anticipating competition while maintaining a long-term view [42][44] Question: What is the company's approach to business development? - The company is selectively looking for opportunities to enhance its pipeline without risking its current strong position [66][70] Question: How does the company view the upcoming European launch? - Management is optimistic about the European launch, noting that the market is better prepared than the U.S. was at launch [75][78] Question: What is the anticipated impact of MFN on pricing in Europe? - The company is optimistic that Europe will recognize innovation and is prepared to approach pricing based on unfolding information [84]

Company Overview - Madrigal Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with significant unmet medical needs [2] - The company's primary medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist targeting the underlying causes of MASH [2] - Rezdiffra is the first and only medication approved by the FDA for treating MASH with moderate to advanced fibrosis, specifically stages F2 to F3 [2] - An ongoing Phase 3 outcomes trial is assessing Rezdiffra for the treatment of compensated MASH cirrhosis, corresponding to stage F4c [2] Upcoming Events - Madrigal Pharmaceuticals will participate in the 46th Annual Global Goldman Sachs Health Care Conference on June 11, 2025, at 10:40 A.M. EDT [1] - The presentation will be available via live webcast, with a replay accessible after the event [1]

Core Insights - Madrigal Pharmaceuticals has successfully launched Rezdiffra (resmetirom) for nonalcoholic steatohepatitis (NASH) in April 2024, achieving net sales of $137.3 million in Q1, surpassing the $100 million per quarter threshold [1] Company Performance - The drug Rezdiffra has shown strong market performance shortly after its launch, indicating a robust demand in the NASH treatment space [1] Market Context - The success of Rezdiffra reflects the growing interest and investment in biotech stocks, particularly those focused on FDA-regulated industries and significant health conditions like NASH [1]

Madrigal Pharmaceuticals (MDGL) Update / Briefing May 13, 2025 08:00 AM ET Speaker0 Good day. Thank you for standing by. Welcome to Montreal Pharmaceuticals' Residra Two Year Compensated Mascidrosis Data and EASL twenty twenty five Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. As a reminder, today's conference call is being recorded. I would now like to introduce Ms. Tina Ventura, Chief Investor Relat ...

Core Insights - Madrigal Pharmaceuticals announced positive two-year results from the Phase 3 MAESTRO-NAFLD-1 trial of Rezdiffra, showing significant improvements in liver health metrics among patients with compensated MASH cirrhosis [1][2][3] Group 1: Study Results - The study involved 122 patients, with 113 completing two years of treatment, demonstrating a mean reduction of 6.7 kPa in liver stiffness, which is statistically significant [5][8] - 65% of patients with clinically significant portal hypertension (CSPH) at baseline moved to lower risk categories by year two, indicating a positive shift in patient outcomes [4][8] - Among patients with probable CSPH at baseline, 57% transitioned to the no/low CSPH category, further supporting the efficacy of Rezdiffra [4] Group 2: Safety and Tolerability - Rezdiffra was well-tolerated, with a low discontinuation rate due to adverse events; the most common side effects included diarrhea, COVID-19, and nausea [6][8] - Safety data were consistent with previous studies, reinforcing the drug's favorable safety profile [6] Group 3: Mechanism and Future Trials - Rezdiffra acts as a THR-β agonist, which is mechanistically supported to improve outcomes in patients with compensated MASH cirrhosis [7] - A larger placebo-controlled study is anticipated to confirm the benefits of Rezdiffra in this high-risk population, with ongoing trials expected to provide further insights [2][14] Group 4: Market Context - MASH is projected to become the leading cause of liver transplantation in the U.S., highlighting the urgent need for effective treatments [10][11] - An estimated 1.5 million patients have been diagnosed with MASH in the U.S., with Madrigal targeting approximately 315,000 patients with moderate to advanced fibrosis [12]