Rezdiffra (resmetirom)

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Madrigal Pharmaceuticals Announces Grants of Inducement Awards under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2025-06-17 20:05
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]
Madrigal Pharmaceuticals to Participate in the 46th Annual Global Goldman Sachs Health Care Conference
Globenewswire· 2025-06-02 12:00
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]
In Search Of A Tailwind, Sailing The Doldrums With Madrigal Pharmaceuticals
Seeking Alpha· 2025-05-17 12:10
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 Announces New Clinical Data Demonstrating Rezdiffra™ (resmetirom) Significantly Improved Multiple Noninvasive Tests and Portal Hypertension Risk in Patients with Compensated MASH Cirrhosis
Globenewswire· 2025-05-10 11:15
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]
Madrigal Pharmaceuticals Reports First-Quarter 2025 Financial Results and Provides Corporate Updates
Globenewswire· 2025-05-01 11:00
First-quarter 2025 Rezdiffra™ (resmetirom) net sales of $137.3 million As of March 31, 2025, more than 17,000 patients on Rezdiffra Two-year compensated MASH cirrhosis (F4c) data from MAESTRO-NAFLD-1 trial selected as oral late-breaker at EASL Congress (May 7-10)Appointed David Soergel, M.D., to Chief Medical Officer; Rebecca Taub, M.D., named Senior Scientific and Medical Advisor Appointed Jacqualyn Fouse, Ph.D., to Board of DirectorsReports cash, cash equivalents, restricted cash and marketable securities ...