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 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.
Edgewise Therapeutics (EWTX) will host a symposium at the 27th International Hybrid Annual Congress of the World Muscle Society in Halifax, Nova Scotia, from October 11-15, 2022. The event will feature the presentation of 6-month interim results from the ARCH study on EDG-5506, an investigational therapy for Becker Muscular Dystrophy. This therapy targets fast skeletal muscle fibers to reduce damage. Key opinion leaders will discuss related topics. The symposium is accessible only to registered attendees and will also be streamed online.
Edgewise Therapeutics, Inc. (NASDAQ: EWTX) has successfully closed an upsized public offering of 13,372,093 shares at a price of $10.32 per share, yielding total gross proceeds of $138 million. This offering was led by J.P. Morgan and SVB Securities as joint book-running managers. The registration statement for the offering was declared effective by the
Edgewise Therapeutics (NASDAQ: EWTX) announced the pricing of an upsized public offering of 11,627,907 shares at $10.32 per share, expected to raise approximately $120 million before expenses. The offering includes an option for underwriters to purchase an additional 1,744,186 shares. The offering will close around September 16, 2022, subject to customary conditions. J.P. Morgan and SVB Securities are the joint book-running managers, with Wedbush PacGrow as the lead manager. The proceeds will support the development of innovative treatments for severe neuromuscular and cardiac disorders.