Welcome to our dedicated page for Edgewise Therapeutics news (Ticker: EWTX), a resource for investors and traders seeking the latest updates and insights on Edgewise Therapeutics stock.
Edgewise Therapeutics, Inc. (NASDAQ: EWTX) is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for muscular dystrophies and serious cardiac conditions. The Edgewise news feed on Stock Titan aggregates company announcements, press releases, and other coverage related to its clinical programs, corporate developments, and financial updates.
Investors and observers following EWTX news will see regular updates on the company’s lead product candidates. These include sevasemten, an orally administered first-in-class fast skeletal myosin inhibitor in late-stage trials for Becker and Duchenne muscular dystrophies; EDG-7500, a cardiac sarcomere modulator in Phase 2 development for hypertrophic cardiomyopathy; and EDG-15400, a cardiac sarcomere modulator in Phase 1 development for heart failure. News items often describe trial progress, such as enrollment status, interim results, and plans for pivotal studies, as well as interactions with regulators.
The Edgewise news stream also features corporate and governance updates, including board and executive appointments, inducement equity grants under Nasdaq Listing Rules, participation in major healthcare and investor conferences, and periodic financial results. These disclosures provide context on how the company is building its organization and funding its research and development activities.
By monitoring this page, readers can review historical and recent EWTX news related to muscular dystrophy and cardiovascular programs, clinical milestones, and corporate actions as reported by the company in its public communications.
Edgewise Therapeutics (Nasdaq: EWTX) will present data on sevasemten, their first-in-class oral fast skeletal myosin inhibitor for Becker muscular dystrophy (BMD), at the MDA Clinical and Scientific Conference in Dallas from March 16-19, 2025.
The company will host an Industry Forum featuring Dr. Craig M. McDonald and Michael Voto, Jr. discussing BMD patient experiences and clinical advancements. Dr. McDonald will present the CANYON trial results showing sevasemten's effectiveness in reducing muscle damage biomarkers and stabilizing function in BMD patients.
The presentation includes five scientific posters covering:
- North Star Ambulatory Assessment predictions in BMD
- Two-year sevasemten treatment outcomes
- BMD skeletal phenotype analysis
- EDG-4131 myosin inhibitor results in BMD model mice
- Sevasemten's impact on muscle injury markers in the CANYON Phase II trial
Edgewise Therapeutics (Nasdaq: EWTX), a muscle disease biopharmaceutical company, has announced its upcoming participation at the Leerink Partners Global Healthcare Conference. The presentation is scheduled for Tuesday, March 11, 2025, at 1:40 pm ET.
The event will feature a live webcast accessible through the Edgewise Events & Presentations page. Viewers are advised to connect several minutes before the start time to ensure proper connection. The presentation recording will be available for -time replay after the conference.
Edgewise Therapeutics (NASDAQ: EWTX) reported its Q4 and full year 2024 financial results, highlighting significant progress in its muscular dystrophy and cardiovascular portfolio. The company completed enrollment for the GRAND CANYON global pivotal study of sevasemten in Becker muscular dystrophy, with 175 adults across 51 sites in 12 countries.
Key financial metrics for Q4 2024 include:
- Cash position of $470.2 million
- R&D expenses of $36.4 million (up $4.2M from previous quarter)
- G&A expenses of $9.2 million
- Net loss of $39.7 million ($0.42 per share)
The company announced positive Phase 2 CANYON trial results and expects to report data from multiple ongoing trials in 2025, including: CIRRUS-HCM trial of EDG-7500 in Q1 2025, and Phase 2 LYNX and FOX trials of sevasemten in Duchenne muscular dystrophy in H1 2025. GRAND CANYON study data is expected in Q4 2026.
Edgewise Therapeutics (NASDAQ: EWTX) announced key leadership changes to support its late-stage clinical development initiatives. Robert Blaustein, M.D., Ph.D. has been appointed as Chief Development Officer (CDO), bringing extensive cardiovascular drug development experience from Merck, where he led the successful development and approval of vericiguat for heart failure treatment. Behrad Derakhshan, Ph.D. has been promoted from Chief Business Officer to Chief Operating Officer (COO).
The company recently reported positive topline data from EDG-7500's Phase 1 trial in healthy subjects and the single-dose arm (part A) of the Phase 2 CIRRUS-HCM trial in patients with obstructive hypertrophic cardiomyopathy (HCM). The company has begun enrolling patients in the 28-day arms (parts B and C) and 12-week open label extension (part D) of the CIRRUS-HCM trial for both obstructive and non-obstructive HCM patients.
Edgewise Therapeutics (NASDAQ: EWTX) provided corporate updates and priorities for 2025, highlighting progress in their muscular dystrophy and cardiovascular programs. The company's lead drug sevasemten, a first-in-class fast skeletal myosin inhibitor for Becker and Duchenne muscular dystrophies, is nearing completion of pivotal cohort enrollment. The company plans to seek FDA feedback on Phase 2 results in first half 2025.
For their cardiovascular program, EDG-7500, a cardiac sarcomere modulator for hypertrophic cardiomyopathy (HCM), will report initial 28-day data in Q1 2025 and 12-week trial results in H2 2025. Key 2024 achievements include raising $232 million through a public offering, positive Phase 2 CANYON trial results for Becker muscular dystrophy, and positive Phase 1 results for EDG-7500 in HCM patients.
Edgewise Therapeutics, a leading muscle disease biopharmaceutical company, will be presenting at the 43rd Annual J.P. Morgan Healthcare Conference on January 13, 2025. The presentation will be led by Kevin Koch, Ph.D., President and CEO, and is scheduled for 1:30 pm PT (4:30 pm ET). Key updates will cover the company's cardiovascular and muscular dystrophy programs and outline 2025 milestones. The presentation will be webcast live, and a replay will be available for a time on the Edgewise Events & Presentations page. Attendees are advised to connect several minutes early to ensure a timely connection.
Edgewise Therapeutics (NASDAQ: EWTX) announced positive topline results from its Phase 2 CANYON trial of sevasemten in Becker muscular dystrophy patients. The trial met its primary endpoint with a significant 28% reduction in creatine kinase levels, a biomarker of muscle damage. The key secondary endpoint showed stabilization in North Star Ambulatory Assessment (NSAA) scores, with a trend toward improvement compared to placebo.
The study, involving 40 adults and 29 adolescents, demonstrated sevasemten was well-tolerated with no new safety concerns. Additional functional measures showed positive trends, and 99% of eligible participants enrolled in the MESA open-label extension trial. The company plans to complete recruitment for the GRAND CANYON pivotal cohort by Q1 2025 and will engage with FDA and EMA regarding marketing authorization strategies.
Edgewise Therapeutics (Nasdaq: EWTX) has issued a statement clarifying its relationship with Dr. Han Phan at Rare Disease Research following an FDA warning letter. The company emphasized that the FDA's warning letter to Dr. Phan, issued on November 27, 2024, was based on her work with another company and is completely unrelated to any Edgewise clinical trials or data.
The company has conducted multiple audits of Dr. Phan's site and confirms that data from Edgewise clinical trials are being collected and stored in compliance with FDA requirements.
Edgewise Therapeutics (Nasdaq: EWTX), a muscle disease biopharmaceutical company, has announced its upcoming participation at the Piper Sandler 36th Annual Healthcare Conference. The presentation is scheduled for Tuesday, December 3, 2024, at 1 pm ET.
The event will feature a live webcast accessible through the company's Events & Presentations page. Viewers are advised to connect several minutes before the start time to ensure proper connection. The webcast recording will be available for replay for a period after the conference.
Edgewise Therapeutics (EWTX) reported Q3 2024 financial results and updates on its clinical programs. The company maintains a strong cash position of $492.5 million as of September 30, 2024. Q3 net loss was $34.1 million ($0.36 per share), compared to $31.5 million in Q2. R&D expenses increased to $32.2 million from $30.7 million in Q2.
The company is advancing multiple Phase 2 trials: CANYON for Becker muscular dystrophy (top-line results expected December 2024), LYNX and FOX for Duchenne muscular dystrophy, and CIRRUS-HCM for hypertrophic cardiomyopathy. Positive Phase 1 data was reported for EDG-7500 in healthy subjects and Phase 2 CIRRUS-HCM trial in obstructive HCM patients.