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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: An Encouraging Start For Rezdiffra
Seeking Alpha· 2025-05-06 20:20
Group 1 - The article highlights the focus on Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), particularly following its first quarter results and the approval of its drug candidate Rezdiffra as the first treatment for a specific condition [2] - The Biotech Forum community is actively discussing lucrative buy-write or covered call opportunities on selected biotech stocks, indicating a trend in investment strategies within the biotech sector [1] - The Biotech Forum offers a model portfolio featuring 12-20 high upside biotech stocks, along with live chat discussions and weekly research updates, showcasing a collaborative investment approach [2] Group 2 - The article does not provide any specific financial data or performance metrics related to Madrigal Pharmaceuticals or the broader biotech industry [3][4]
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 ...
Madrigal to Present Late-Breaking Resmetirom Data in Patients with Compensated MASH Cirrhosis at the EASL Congress
GlobeNewswire News Room· 2025-04-29 12:00
CONSHOHOCKEN, Pa., April 29, 2025 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction- associated steatohepatitis (MASH), today announced six presentations at the upcoming European Association for the Study of the Liver (EASL) Congress, taking place from May 7-10, 2025, in Amsterdam, the Netherlands. Madrigal will share detailed two-year data from the open-label compensated MASH cirrhosis (F4c) arm ...
过冬的医药行业,不冬眠的医药基金
远川投资评论· 2025-04-02 07:43
一年前,施跃和他的团队做了一个国内基金圈少有人敢于尝试的事情。 2024年3月14日下午,和谐汇一的官方公众号发表文章,对即将开启百亿美金蓝海市场的NASH(非酒精性脂肪肝)赛道进行了详细介绍[1]。业内很多人都知道当 日晚间,FDA即将公布对首款NASH治疗药物Rezdiffra的评审,如果最终获批,将会创造该领域的历史性突破。 在 FDA 公告前,和谐汇一敢于对这项突破性技术做出前瞻预判,在小圈子里引起了很多赞叹。 事实上,这已经不是和谐汇一医药团队第一次做出这种判断。无论是港股上市的创新药出海龙头,还是因为获得了某款国产创新药海外授权而涨幅超十倍的美股 明星公司,和谐汇一的买入点常常都是市场还没有形成"一致性预期"的时候。 对于施跃和医药团队里的其他年轻研究员来说, 他们凭借对医药行业的深入研究和敏锐洞察,以及在投资实践中积累的经验,生动诠释 了"超额收益往往来自于 非共识的正确" 这一理念。 但从理论到实践,"非共识"往往需要一个投资团队投入专注的研究心力,并有果敢的魄力在该出手的时候,坚决出手。 放在整个行业维度,这种认知上的加持、信念上的加码也是一个医药投研团队在过去几年国内医药行业整体低迷的现实 ...
Galmed Pharmaceuticals Secures New Patent Grant Extending Aramchol's Patent Protection to 2039, Strengthening Leadership in NASH/MASH Combination Therapy
Prnewswire· 2025-03-20 12:55
Core Viewpoint - Galmed Pharmaceuticals has secured a new patent for the combination therapy of Aramchol and Resmetirom for treating non-alcoholic steatohepatitis (NASH), extending patent protection until September 2039, which positions the company to capitalize on the commercial potential of Aramchol in the growing NASH market [1][2][5]. Company Summary - Galmed Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing Aramchol for liver and fibro-inflammatory diseases, particularly NASH [12]. - The company believes that Aramchol's unique mechanism of action as a stearoyl-CoA desaturase-1 (SCD1) modulator provides a competitive advantage, making it suitable for combination therapies [6][7]. - The recent patent strengthens Galmed's intellectual property portfolio, enhancing its strategic flexibility for partnerships and commercialization [11]. Industry Summary - The global NASH treatment market is projected to grow from approximately $5.2 billion in 2022 to over $48 billion by 2035, indicating significant unmet needs and revenue opportunities [5]. - The industry is shifting towards combination therapies for NASH, as no single agent is expected to fully address the disease's complexities [4][10]. - Recent regulatory developments, including the FDA's approval of Resmetirom as the first drug for NASH patients with liver fibrosis, highlight the therapeutic potential in this area [4].