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Edgewise Therapeutics to Present at the Leerink Global Healthcare Conference on March 11, 2026
Prnewswire· 2026-03-04 13:00
Core Viewpoint - Edgewise Therapeutics is set to present at the Leerink Global Healthcare Conference on March 11, 2026, highlighting its focus on developing novel therapeutics for muscle diseases and cardiac conditions [1]. Company Overview - Edgewise Therapeutics, Inc. is a biopharmaceutical company specializing in muscle diseases, particularly muscular dystrophies and serious cardiac conditions [1]. - The company is recognized for its expertise in muscle physiology, which is driving the development of a new generation of therapeutics [1]. Key Products in Development - Sevasemten is an orally administered first-in-class fast skeletal myosin inhibitor currently in late-stage clinical trials for Becker and Duchenne muscular dystrophies [1]. - EDG-7500 is a novel cardiac sarcomere modulator in Phase 2 clinical development aimed at treating symptomatic hypertrophic cardiomyopathy [1]. - EDG-15400 is another cardiac sarcomere modulator in Phase 1 clinical development targeting heart failure [1]. Mission Statement - The company is dedicated to changing the lives of patients and families affected by serious muscle diseases [1].
Edgewise Therapeutics to Present on Sevasemten for the Treatment of Becker Muscular Dystrophy at the 2026 MDA Clinical and Scientific Conference
Prnewswire· 2026-03-03 13:00
Core Insights - Edgewise Therapeutics will present new data on sevasemten for Becker muscular dystrophy at the 2026 MDA Clinical and Scientific Conference, highlighting the importance of community and care definition [1] Company Overview - Edgewise Therapeutics is a biopharmaceutical company focused on developing novel therapeutics for muscular dystrophies and serious cardiac conditions [1] - The company is advancing sevasemten, an orally administered first-in-class fast skeletal myosin inhibitor, currently in late-stage clinical trials for Becker and Duchenne muscular dystrophies [1] Conference Participation - The 2026 MDA Clinical and Scientific Conference will take place from March 8–11, 2026, in Orlando, Florida, where Edgewise will host a lunch forum and present scientific posters [1] - The lunch forum will focus on Becker natural history, community progress, and multi-disciplinary care, featuring experts from various institutions [1] Presentation Highlights - Key presentations include: - Long-term stabilization of function in Becker with sevasemten preventing functional decline for up to 3.5 years [1] - Effects of sevasemten on left ventricular ejection fraction (LVEF) and NT-proBNP in adults with Becker muscular dystrophy [1] - Patient-focused drug development insights through interviews [1] - Research on female carriers of BMD and DMD mutations showing elevated muscle injury proteins [1] Regulatory Milestones - Sevasemten has received FDA Orphan Drug Designation for Becker and Duchenne muscular dystrophies, Rare Pediatric Disease Designation for Duchenne, and Fast Track designations for both conditions [1] - The drug has also secured EMA Orphan Drug Designations for Becker and Duchenne muscular dystrophies [1]
Why Edgewise Therapeutics Stock Crushed the Market on Monday
The Motley Fool· 2026-02-10 01:05
Core Viewpoint - Edgewise Therapeutics is experiencing a positive market response following a bullish recommendation from analyst Yasmeen Rahimi of Piper Sandler, who has set a price target of $51 per share for the company's stock [2][3]. Company Overview - Edgewise Therapeutics' stock rose by 4% in a single day, outperforming the S&P 500 index, which only increased by 0.5% [2]. - The current stock price is $30.27, with a market capitalization of $3.1 billion [7]. Clinical Development - The company is advancing its leading cardiovascular drug candidate, EDG-7500, which targets hypertrophic cardiomyopathy (HCM) and is currently in a Phase 2 clinical trial [5][6]. - A readout from the clinical trial is expected in the second quarter of the calendar year, and the drug's novel functionality is anticipated to provide a competitive edge in the market [6]. Pipeline Potential - In addition to EDG-7500, Edgewise is developing Sevasemten, a treatment for muscular dystrophy, which is also well advanced in the development cycle [9]. - The analyst believes that several other pipeline programs have solid potential, indicating a robust future for the company's product offerings [9].
Edgewise Therapeutics, Inc. (EWTX) Outlines Priorities For 2026
Yahoo Finance· 2026-01-15 16:35
Core Insights - Edgewise Therapeutics, Inc. (NASDAQ:EWTX) is recognized as one of the top 14 booming stocks to buy, with a stock price increase of over 57% in the last three months as of January 12 [1] Company Updates - On January 13, Edgewise Therapeutics closed 3% higher after providing a corporate update and outlining its priorities for 2026 [2] - Major milestones for 2026 include expected top-line findings for Sevasemten by Q4, which would be the first approved therapy for Becker disease [2] - The company anticipates Phase 2 results for its selective cardiac sarcomere modulator, EDG-7500, in the first half of the year, aimed at treating hypertrophic cardiomyopathy (HCM) [2] Analyst Ratings - The stock has a one-year average share price target of $38.14, indicating an upside potential of 58.06% as of January 12 [2] - Wall Street analysts maintain a consensus Strong Buy rating for Edgewise Therapeutics [2] - Stifel Nicolaus has a Hold rating with a $16 price target, while JPMorgan has reiterated an Overweight rating on the stock [2] Company Profile - Edgewise Therapeutics is a biopharmaceutical company focused on developing therapeutics for muscular dystrophies and cardiac diseases [2]
Edgewise Therapeutics to Present at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026
Prnewswire· 2026-01-06 13:00
Core Insights - Edgewise Therapeutics, Inc. is a leading biopharmaceutical company focused on developing novel therapeutics for muscle diseases and serious cardiac conditions [3] Group 1: Company Overview - Edgewise Therapeutics specializes in therapeutics for muscular dystrophies and cardiac conditions, leveraging deep expertise in muscle physiology [3] - The company is developing Sevasemten, a first-in-class fast skeletal myosin inhibitor, which is in late-stage clinical trials for Becker and Duchenne muscular dystrophies [3] - EDG-7500 is a novel cardiac sarcomere modulator for hypertrophic cardiomyopathy, currently in Phase 2 clinical development [3] - EDG-15400 is another cardiac sarcomere modulator aimed at treating heart failure, which is in Phase 1 clinical development [3] - The mission of Edgewise is to change the lives of patients and families affected by serious muscle diseases [3] Group 2: Event Details - Kevin Koch, Ph.D., President and CEO of Edgewise Therapeutics, will present at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026, at 8:15 am PT [1][2] - The presentation will be available via a live webcast, with a link accessible on the Edgewise Events & Presentations page [2]
Edgewise Therapeutics Appoints Commercial Biotech Executive Christopher Martin to its Board of Directors
Prnewswire· 2025-11-20 13:00
Core Insights - Edgewise Therapeutics, Inc. has appointed Christopher Martin, a biotechnology veteran, to its Board of Directors, enhancing its leadership team as it prepares for significant product launches [1][2][3] Company Overview - Edgewise Therapeutics is focused on developing novel therapeutics for muscular dystrophies and serious cardiac conditions, with a strong emphasis on muscle physiology [4] - The company is advancing its lead product, Sevasemten, which is in late-stage clinical trials for Becker and Duchenne muscular dystrophies, and is also developing EDG-7500 and EDG-15400 for cardiac conditions [4] Leadership Background - Christopher Martin previously served as Chief Commercial Officer for Verona Pharma, which was acquired by Merck & Co. for approximately $10 billion in October 2025, and has extensive experience in building commercial organizations and launch strategies [3] - His past roles include Executive Director of Marketing at SK Life Science and Head of Marketing at Cempra, where he led the development and launch strategies for multiple products [3]
Edgewise Therapeutics to Participate in Upcoming Investor Conferences
Prnewswire· 2025-11-07 13:00
Core Insights - Edgewise Therapeutics, Inc. is a leading biopharmaceutical company focused on developing novel therapeutics for muscle diseases and serious cardiac conditions [2][3]. Group 1: Investor Conferences - Management will participate in multiple investor conferences, including the Guggenheim 2nd Annual Healthcare Innovation Conference on November 11, 2025, at 8:30 am ET, the Piper Sandler 37th Annual Healthcare Conference on December 2, 2025, at 2 pm ET, and the 8th Annual Evercore Healthcare Conference on December 3, 2025, at 3:25 pm ET [1]. Group 2: Product Development - Sevasemten is an orally administered first-in-class fast skeletal myosin inhibitor in late-stage clinical trials for Becker and Duchenne muscular dystrophies [2]. - EDG-7500 is a novel cardiac sarcomere modulator for treating hypertrophic cardiomyopathy and other diseases of diastolic dysfunction, currently in Phase 2 clinical development [2]. - EDG-15400 is another cardiac sarcomere modulator for heart failure, currently in Phase 1 clinical development [2]. Group 3: Company Mission - The company is dedicated to changing the lives of patients and families affected by serious muscle diseases [2].
Edgewise Therapeutics Reports Positive Results on Sevasemten Program for Becker and Duchenne Muscular Dystrophies
Prnewswire· 2025-06-26 10:00
Core Insights - Edgewise Therapeutics has reported positive results from its sevasemten program for Becker and Duchenne muscular dystrophies, demonstrating sustained disease stabilization and a clear path to potential registration as the first therapy for Becker [1][3]. Group 1: Becker Muscular Dystrophy - The MESA trial data showed that 99% of eligible participants (n=85) are enrolled, with significant improvements in North Star Ambulatory Assessment (NSAA) scores, indicating sustained disease stabilization over 18 months [2]. - Participants from the CANYON trial who transitioned to MESA exhibited an average NSAA score improvement of 0.8 points from baseline, while those on placebo showed a 0.2 point improvement after starting sevasemten [2]. - The FDA has provided a clear path for sevasemten registration, emphasizing the importance of NSAA as a clinically meaningful endpoint for traditional approval [3]. Group 2: Duchenne Muscular Dystrophy - Encouraging topline data from Phase 2 trials (LYNX and FOX) indicate that sevasemten is well-tolerated and shows potential for reducing functional decline at a target dose of 10 mg [4][6]. - The LYNX trial focuses on four- to nine-year-old participants, while the FOX trial involves six- to fourteen-year-old participants previously treated with gene therapy, both assessing safety and biomarkers of muscle damage [5][6]. - The company plans to meet with the FDA in Q4 2025 to discuss Phase 3 design, aiming to initiate the pivotal study in 2026 [7]. Group 3: Company Overview - Edgewise Therapeutics is a biopharmaceutical company focused on developing novel therapeutics for muscular dystrophies and cardiac conditions, with sevasemten being a first-in-class fast skeletal myosin inhibitor [9][12]. - The company has achieved significant regulatory milestones, including FDA Orphan Drug Designation and Fast Track designations for both Becker and Duchenne [9]. - Edgewise is dedicated to changing the lives of patients affected by serious muscle diseases, with a strong emphasis on innovative therapeutic solutions [12].