Edgewise Therapeutics, Inc. (NASDAQ:EWTX) is among the 14 best booming stocks to buy right now. The stock is surging and has gained over 57% in the last three months, as of the close on January 12. Edgewise Therapeutics, Inc. (EWTX) Outlines Priorities For 2026 Shares closed 3% higher on Tuesday, January 13, after the company provided a corporate update and outlined its priorities for 2026. Major milestones for the current year include the expectation of top-line findings for Sevasemten by the fourth qua ...

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PresentationWelcome, everyone, to the 44th Annual JPMorgan Healthcare Conference. My name is Tessa Romero, and I'm one of the senior biotech analysts here at JPMorgan. Our next presenting company is Edgewise Therapeutics. And presenting on behalf of the company, we have President and CEO, Kevin Koch. Kevin, over to you.Kevin KochPresident, CEO & Director Okay. Thanks, Tessa. Always great to thanks for joining today. Let me get organized here. These are the forward-looking statements. Edgewise Therapeutics i ...

Edgewise Therapeutics Conference Call Summary Company Overview - **Company**: Edgewise Therapeutics (NasdaqGS:EWTX) - **Focus**: Biopharmaceutical company specializing in muscle diseases, particularly muscular dystrophy and cardiac conditions [2][4] Key Programs and Developments Muscular Dystrophy - **Sevasamtan**: Drug for muscular dystrophy, pivotal study enrollment completed in February 2025, data readout expected by the end of 2026 [2][4] - **Duchenne Program**: Positive data from studies showing decreased decline rates in patients previously treated with steroids and gene therapy [2][3] - **Becker Program**: Focus on a rare genetic disease with a unique mechanism of action targeting muscle damage, showing promising results in clinical trials [5][6][8] Cardiovascular Assets - **EDG-7500**: Cardiac sarcomere modulator with a strong safety profile, showing no changes in left ventricular ejection fraction (LVEF) [3][4][18] - **EDG-15400**: Second-generation molecule filed for IND, expected to enter HFpEF studies in the second half of 2026 [4][25] Financial Position - **Funding**: Successfully raised $200 million, with a total of $563 million in cash and no debt, providing a runway through 2028 [4][24] Market Potential - **Becker Disease Market**: Estimated at $5 billion, with 6,000 patients in the U.S. and 12,000 in major markets [14] - **Hypertrophic Cardiomyopathy (HCM) Market**: Potentially a $10 billion opportunity, targeting 165,000 symptomatic patients [23][24] Clinical Data and Efficacy - **Becker Program**: - 99% of patients in open-label extension remain on study, indicating durable response [8] - Statistically significant decreases in biomarkers of muscle damage [7][10] - NorthStar endpoint measures functional capacity, with a target of a 1-2 point change [8][11] - **EDG-7500**: - 89% of patients showed significant improvement in KCCQ scores [20] - No relationship between drug concentration and changes in ejection fraction, indicating a unique safety profile [22][23] Regulatory and Development Strategy - **FDA Engagement**: Plans to discuss trial designs for phase three studies in obstructive and non-obstructive HCM with the FDA [25][44] - **Commercial Strategy**: Building a commercial backbone for Sevasamtan while executing on HCM opportunities [49][50] Upcoming Milestones - **Data Readouts**: - Becker pivotal study results expected in December 2026 [25] - 12-week study data for EDG-7500 anticipated in the second quarter of 2026 [25] - **NDA Submissions**: Planned for 2027 following successful trial outcomes [24][25] Conclusion - Edgewise Therapeutics is positioned for significant growth with two differentiated assets in the muscular dystrophy and cardiovascular spaces, backed by strong financials and promising clinical data. The company is focused on executing its development and commercial strategies effectively to capitalize on the substantial market opportunities ahead [24][26]

Forward Looking Statement This presentation contains contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this presentation that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the potential of, and expectations regarding, Edgewise's product candidates and programs, including sevasemten, EDG-7500, ...

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]

Company Overview - Edgewise Therapeutics is a clinical-stage biopharmaceutical company focused on precision medicines for rare muscle disorders, particularly dystrophinopathies [5][8] - The company’s lead product candidate, EDG-5506, targets Duchenne and Becker muscular dystrophy [8] - As of the latest period, Edgewise has not generated commercial revenue, relying on a research-driven business model [8] Financial Performance - As of September 30, Edgewise Therapeutics had a market capitalization of $2.61 billion and reported a net income loss of $157.24 million over the trailing twelve months [4] - The stock price was $24.62, reflecting a 14% decline over the past year, underperforming the S&P 500, which increased by approximately 15.5% during the same period [3][4] - The company reported a third-quarter net loss of about $40.7 million, attributed to increased R&D spending as it advanced multiple late-stage and mid-stage programs [10] Investment Activity - Foresite Capital Management VI fully exited its position in Edgewise Therapeutics during the third quarter, selling 585,000 shares valued at approximately $7.67 million [1][2] - Prior to the exit, Edgewise represented about 4.3% of Foresite's assets under management [3] - The exit reflects a recalibration of risk-reward dynamics for Foresite, as the remaining portfolio is heavily concentrated in early-stage biotech [11] Market Context - Edgewise's stock experienced significant volatility, with shares dropping as much as 40% from earlier highs following a $200 million underwritten offering announced in April [9] - By the end of the third quarter, the stock remained down year-over-year despite a strong balance sheet with approximately $563 million in cash and marketable securities [10]

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Group 1 - The article discusses Edgewise Therapeutics, Inc. (EWTX) and its ongoing development of EDG-7500 despite safety concerns related to atrial fibrillation (AF) [2] - The author, Terry Chrisomalis, has extensive experience in the biotech sector and provides in-depth analysis through the Biotech Analysis Central service, which includes a library of over 600 articles and a model portfolio of small and mid-cap stocks [2] - The service is available for a monthly fee of $49, with a discounted annual plan at $399, offering a 33.50% savings [1] Group 2 - The article does not contain any specific financial data or performance metrics related to Edgewise Therapeutics or its products [4] - There are no disclosed positions or plans to invest in the companies mentioned, indicating an unbiased perspective in the analysis [3]

Core Viewpoint - Edgewise Therapeutics has reported promising interim data from its Phase 2 clinical trial of EDG-7500, a treatment for hypertrophic cardiomyopathy (HCM), leading to a significant increase in its stock price by nearly 26% [1][2][6] Group 1: Clinical Trial Results - The interim data from the ongoing Phase 2 clinical trial of EDG-7500 showed evidence of clinical activity across significant HCM disease markers [2][4] - The drug maintained a favorable safety profile and was generally well-tolerated among participants [4] - In the current part D of the trial, over 40 participants are enrolled, with approximately 70% having reached a dose of at least 100 milligrams as of December 23 [4] Group 2: Market Reaction and Company Outlook - Following the positive news, Edgewise's share price surged to $27.29, reflecting a market capitalization of $2.3 billion [5] - The CEO of Edgewise, Kevin Koch, expressed excitement about exceeding the year-end enrollment goal in Part D of the CIRRUS-HCM trial, indicating strong interest from patients and physicians [6] - Despite the encouraging results, the company acknowledges that the drug is still in Phase 2 and has a long path ahead before potential regulatory approval [6]