Edgewise Therapeutics, Inc. reports developments from its muscle disease biopharmaceutical pipeline, including sevasemten for Becker and Duchenne muscular dystrophies and cardiac sarcomere modulators such as EDG-7500 and EDG-15400 for serious cardiac conditions. Company updates commonly cover clinical data presentations, open-label extension findings, trial-program progress, and financial results tied to research and development activity.
Recurring EWTX news also includes scientific-conference participation, Nasdaq inducement equity grants under the 2024 Inducement Equity Incentive Plan, and corporate communications about its focus on muscle physiology, dystrophinopathies, hypertrophic cardiomyopathy, and heart failure.
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 November 16, 2022, at 3:00 pm ET, while the Piper Sandler 34th Annual Healthcare Conference is scheduled for November 29, 2022, at 8:30 am ET. Both presentations will be webcast live, with replay availability. Edgewise focuses on developing therapies for rare muscle disorders, notably pursuing its lead candidate, EDG-5506, in clinical trials.
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 $365 million as of September 30, 2022, the company is advancing its clinical trials, including the CANYON Phase 2 trial for BMD and the newly initiated LYNX Phase 2 trial for Duchenne muscular dystrophy (DMD). However, net losses increased to $17.5 million for Q3 2022, compared to $16.1 million in the prior quarter.
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 SEC. This capital infusion supports Edgewise's focus on developing innovative treatments for rare neuromuscular and cardiac disorders.
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.
Edgewise Therapeutics (NASDAQ: EWTX) intends to offer and sell $100 million of its common stock in an underwritten public offering. An additional 30-day option for underwriters to purchase up to $15 million of common stock is also included. The offering is subject to market conditions and no assurance can be given regarding its completion or terms. J.P. Morgan and SVB Securities are acting as joint book-running managers. Edgewise focuses on innovative treatments for rare neuromuscular and cardiac disorders, indicating potential growth opportunities with the capital raised.
Edgewise Therapeutics (NASDAQ: EWTX) announced positive interim results from its ARCH study, focusing on the investigational drug EDG-5506 for Becker muscular dystrophy (BMD). After four months, participants exhibited an average 1.17-point increase in the North Star Ambulatory Assessment (NSAA) and significant reductions in muscle damage biomarkers: serum creatine kinase levels decreased by 29% and fast skeletal muscle troponin I by 74%. EDG-5506 was well-tolerated, with no serious adverse events. A webcast discussing the findings is scheduled for September 12 at 8:30 a.m. ET.