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) announced its participation at the 29th International Annual Congress of the World Muscle Society in Prague, October 8-12, 2024. The company will present an industry-sponsored symposium and seven scientific posters highlighting the effects of sevasemten in individuals with Becker muscular dystrophy.
The symposium, titled 'Understanding disease progression and a potential novel agent to protect muscle,' will feature key opinion leaders and discuss positive two-year topline results from the ARCH trial. The scientific posters will cover topics such as reduced muscle damage biomarkers, functional stabilization, and proteomic responses to sevasemten in Becker muscular dystrophy patients.
Sevasemten is an orally administered small molecule designed to prevent contraction-induced muscle damage in muscular dystrophies. The presentations will provide insights into biomarker and functional endpoints being studied in the CANYON Phase 2 trial.
Edgewise Therapeutics (Nasdaq: EWTX) announced positive top-line data for EDG-7500, a novel oral cardiac sarcomere modulator, from its Phase 1 trial in healthy subjects and Phase 2 CIRRUS-HCM trial in patients with obstructive hypertrophic cardiomyopathy (HCM). Key findings include:
1. Phase 1: EDG-7500 was well-tolerated without meaningful changes in left ventricle ejection fraction (LVEF).
2. CIRRUS-HCM: Single-dose trial demonstrated robust left ventricular outflow tract (LVOT) gradient reductions without significant LVEF changes.
3. 67% mean reduction in resting LVOT pressure gradient and 55% mean reduction in provokable LVOT gradient observed at 100 and 200 mg doses.
4. 64% mean reduction in NT-proBNP, a key heart failure biomarker, in the 200 mg cohort.
The company has initiated the 28-day part of CIRRUS-HCM in patients with obstructive and non-obstructive HCM, with initial data expected in Q1 2025.
Edgewise Therapeutics (Nasdaq: EWTX) has announced a live webcast scheduled for September 19, 2024, at 8:30 am ET to discuss top-line data of their drug EDG-7500. The presentation will cover results from two trials:
1. The Phase 1 trial in healthy subjects
2. The single-dose arm of the Phase 2 CIRRUS-HCM trial in patients with obstructive Hypertrophic Cardiomyopathy (HCM)
Dr. Anjali T. Owens, Medical Director at the Center for Inherited Cardiac Disease and Associate Professor of Medicine at the University of Pennsylvania, will join the management team to share her perspective on EDG-7500 and HCM. Interested parties can register for the webcast and access the accompanying slide presentation through the Edgewise events page.
Edgewise Therapeutics (Nasdaq: EWTX) reported Q2 2024 financial results and business highlights. Key developments include:
1. Completed Phase 1 SAD and MAD trial of EDG-7500 in healthy volunteers
2. Dosing patients in Phase 2 CIRRUS-HCM trial of EDG-7500 for obstructive HCM
3. Advancing GRAND CANYON global pivotal cohort of sevasemten in adults with Becker muscular dystrophy
4. Progressing Phase 2 LYNX and FOX trials of sevasemten in children with Duchenne muscular dystrophy
5. Q2 2024 financial results: $511.8M cash and equivalents, R&D expenses $30.7M, G&A expenses $7.4M, net loss $31.5M ($0.34 per share)
The company expects to present topline data for EDG-7500 from Phase 1 and CIRRUS-HCM Part A in September 2024.
Edgewise Therapeutics, Inc. (Nasdaq: EWTX) will present at the RBC Capital Markets Global Healthcare Conference on May 15, 2024, at 3:35 pm ET. The presentation will be webcast live and a replay will be available. Users should connect early for a timely connection.
Edgewise Therapeutics, Inc. (Nasdaq: EWTX) reported financial results for Q1 2024, highlighting progress in their skeletal and cardiac muscle programs. Positive two-year results for sevasemten in Becker, advancements in GRAND CANYON pivotal cohort, initiation of CIRRUS-HCM trial, and expansion of LYNX trial in Duchenne were key highlights. The Company also reported cash, cash equivalents, and marketable securities of approximately $532.8 million as of March 31, 2024.
Edgewise Therapeutics, Inc. (Nasdaq: EWTX) has appointed Arlene Morris, a seasoned biotechnology industry veteran, to its Board of Directors. With over 30 years of experience in executive management and board roles, Morris brings invaluable expertise in strategic development and operational excellence to the company. As the CEO of Willow Advisors, she advises biotech companies on financing, strategy, and business development. Her previous roles include leading public biotechnology companies like Syndax Pharmaceuticals and Affymax. Edgewise Therapeutics looks forward to leveraging Morris' wealth of experience to advance its mission of helping patients and families affected by serious muscle diseases.
Edgewise Therapeutics, Inc. (Nasdaq: EWTX) has dosed the first patient in the Phase 2 CIRRUS-HCM trial of EDG-7500, a novel oral cardiac sarcomere modulator designed to address issues associated with obstructive Hypertrophic Cardiomyopathy (HCM). The trial will assess safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with obstructive HCM. Positive preclinical data has led to the advancement of EDG-7500 into this trial, showing encouraging effects on left ventricular outflow tract gradient relief and ventricular function. The company expects to report data from the trial in the third quarter of 2024 and plans to initiate further trials in the second half of 2024 and fourth quarter of 2024.
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