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Edgewise Therapeutics, Inc. (NASDAQ: EWTX) is a biotechnology company dedicated to the development of novel therapies for severe, rare muscle disorders. Headquartered in Boulder, Colorado, the company is renowned for its innovative approach to treating diseases involving skeletal muscle. Founded with Series A financing from OrbiMed, Edgewise Therapeutics is focused on the discovery, development, and commercialization of orally bioavailable, small molecule therapies designed to address musculoskeletal diseases.
The core mission of Edgewise Therapeutics is to transform the lives of patients suffering from debilitating muscle conditions. The company’s clinical-stage biopharmaceutical expertise is reflected in its robust pipeline of potential treatments, which aim to offer improved patient outcomes and enhanced quality of life.
Among its current projects, Edgewise Therapeutics is working on several promising candidates that target specific muscle-related conditions. By leveraging advanced research methodologies and cutting-edge technology, the company is able to create therapies that are not only effective but also accessible to a broader patient population.
Financially, Edgewise Therapeutics is well-positioned with strong backing from investors and strategic partners. The company continues to achieve significant milestones in its development programs, further solidifying its reputation as a leader in the biopharmaceutical landscape.
In recent news, Edgewise Therapeutics has made noteworthy progress with its clinical trials and has expanded its research partnerships to expedite the development of its drug candidates. The latest developments underline the company's commitment to innovation and excellence in the field of muscle disease therapeutics.
- Location: Boulder, Colorado
- Core Focus: Novel therapies for rare muscle disorders
- Key Projects: Orally bioavailable small molecule therapies
- Partnerships: Supported by OrbiMed and other strategic investors
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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