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. (EWTX) is a clinical-stage biopharmaceutical company pioneering orally administered therapies for severe musculoskeletal disorders. This page serves as the definitive source for verified corporate announcements, clinical development updates, and strategic business developments.
Investors and industry professionals will find timely updates on clinical trial progress, regulatory milestones, and partnership announcements. Our curated news collection provides essential insights into the company's work on dystrophinopathy treatments like Sevasemten and EDG-7500.
Key categories include quarterly financial results, research collaborations, FDA communications, and scientific conference presentations. All content is rigorously verified to ensure accuracy and relevance for investment research purposes.
Bookmark this page for streamlined access to Edgewise Therapeutics' latest developments in neuromuscular treatment innovation. Check regularly for real-time updates on this clinical-stage biopharma leader's progress.
Edgewise Therapeutics (NASDAQ: EWTX) announced the presentation of EDG-7500, a first-in-class oral therapy for hypertrophic cardiomyopathy (HCM), at the American College of Cardiology's 72nd Annual Scientific Session on March 5, 2023. This investigational drug aims to normalize excess cardiac contraction and improve impaired relaxation, addressing both obstructive and non-obstructive HCM. Key findings include significant improvements in cardiovascular pathophysiologies and potent gradient reductions. The company plans to initiate a Phase 1 trial for EDG-7500 in late 2023, supporting further clinical development based on promising preclinical data.
Edgewise Therapeutics (NASDAQ: EWTX) announced significant advancements in clinical trials for EDG-5506 targeting muscular dystrophies. Phase 2 trials for Becker muscular dystrophy (BMD) and Duchenne muscular dystrophy (DMD) have shown promising developments, with interim data expected in late 2023. The company also initiated IND-enabling studies for EDG-7500, a new treatment for hypertrophic cardiomyopathy, set to begin Phase 1 trials in the second half of 2023. As of December 31, 2022, Edgewise reported cash and marketable securities totaling
Edgewise Therapeutics (EWTX), a clinical-stage biopharmaceutical company, announced its participation in the virtual SVB Securities Global Biopharma Conference on February 14, 2023, at 1:00 pm ET. The presentation will be streamed live with a replay available afterward. Edgewise focuses on developing innovative treatments for severe neuromuscular and cardiac disorders, with its lead candidate, EDG-5506, in clinical trials for various muscular dystrophies. Additionally, the company is progressing EDG-7500, a novel treatment for hypertrophic cardiomyopathy. For more details, visit Edgewise's website.
Edgewise Therapeutics (NASDAQ: EWTX) announced its participation in the J.P. Morgan 41st Annual Healthcare Conference on January 10, 2023, at 9:45 am PT (12:45 pm ET). The presentation will be available via a live webcast, with a replay option post-event. Edgewise focuses on developing targeted therapies for severe muscle disorders, including its lead candidate, EDG-5506, aimed at treating Duchenne muscular dystrophy. The company is advancing another candidate, EDG-7500, for hypertrophic cardiomyopathy in preclinical development.
Edgewise Therapeutics (NASDAQ: EWTX) announced plans for a virtual investor call on January 3, 2023, showcasing preclinical data for its lead candidate, EDG-7500, targeting hypertrophic cardiomyopathy (HCM). Commentary will be provided by a leading cardiologist. CEO Kevin Koch stated that the preclinical data could address unmet needs in HCM treatment, with an IND application expected in the second half of 2023. Additionally, the company will present its 2023 outlook at the J.P. Morgan Healthcare Conference on January 10, 2023.
Edgewise Therapeutics (NASDAQ: EWTX) announces the appointment of Marc Semigran, M.D., as Chief Development Officer. Dr. Semigran, with extensive experience in clinical development, previously served as CMO at Renovacor and MyoKardia, leading to their acquisitions. He will guide Edgewise's cardiovascular program, aiming for an IND filing in the latter half of 2023. Dr. Semigran's expertise includes overseeing successful drug development projects, notably mavacamten for hypertrophic cardiomyopathy.
Edgewise Therapeutics, Inc. (NASDAQ: EWTX), a clinical-stage biopharmaceutical company, announced participation in two upcoming investor conferences. The Stifel 2022 Healthcare Conference will take place on
Edgewise Therapeutics reported promising 6-month interim results for EDG-5506 in Becker muscular dystrophy (BMD), showing significant decreases in biomarkers of muscle damage (39% for creatine kinase, 75% for fast skeletal muscle troponin I). With a robust cash position of
Edgewise Therapeutics (EWTX) has initiated the LYNX Phase 2 clinical trial for EDG-5506 in children with Duchenne muscular dystrophy (DMD) at Rare Disease Research in Atlanta, Georgia. The trial aims to evaluate safety, pharmacokinetics, and biomarkers of muscle damage over 12 weeks, followed by a 9-month open-label phase. Approximately 27 children aged 4 to 9 will be enrolled. EDG-5506, a novel myosin modulator, shows promise based on previous studies. Edgewise will host webinars in November to discuss the trial with the community.
Edgewise Therapeutics (NASDAQ: EWTX) announced positive interim results from its ongoing ARCH study, focusing on the safety and efficacy of EDG-5506 in adults with Becker Muscular Dystrophy (BMD). Key findings include a significant 39% reduction in serum creatine kinase and a 75% drop in fast skeletal muscle troponin I, indicating reduced muscle damage. Improved North Star Ambulatory Assessment (NSAA) scores were also reported, with eight out of twelve participants showing functional improvement. EDG-5506 continues to be well-tolerated at increased doses, supporting its potential to alter BMD disease progression.
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