Business
Edgewise Therapeutics Reports Second Quarter 2023 Financial Results and Recent Business Highlights
– Announced positive 12-month topline results from the ARCH open label study of EDG-5506 in adults with Becker muscular dystrophy (Becker) – – Advancing
About this update from Edgewise Therapeutics, Inc.
[{"type":"text","content":"\n– Announced positive 12-month topline results from the ARCH open label study of EDG-5506 in adults with Becker muscular dystrophy (Becker) –\n\n\n– Advancing Phase 2 trial of EDG-5506 in Becker muscular dystrophy (Becker, CANYON), which now includes a pivotal cohort called GRAND CANYON –\n\n\n– Advancing Phase 2 trial of EDG-5506 in Duchenne muscular dystrophy (Duchenne, LYNX) –\n\n\n– Advancing EDG-7500, a novel sarcomere modulator for hypertrophic cardiomyopathy (HCM); Phase 1 start expected in 2H2023 –\n\n\n– Cash, cash equivalents and marketable securities of $310 million as of June 30, 2023 –\n\n\n BOULDER, Colo.--(BUSINESS WIRE)--\nEdgewise Therapeutics, Inc., (Nasdaq: EWTX), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of innovative treatments for severe, genetic neuromuscular and cardiac disorders for which there is significant unmet medical need, today reported financial results for the second quarter of 2023 and recent business highlights.\n\n\n“Edgewise has made significant progress in the first half of the year most notably with the positive ARCH data that have allowed us to quickly pivot our CANYON study to include a potentially registration-enabling cohort in individuals with Becker, a disorder for which there are no approved treatments,” said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise. “The team continues to advance our LYNX, CANYON and DUNE clinical trials of EDG-5506 in addition to advancing EDG-7500, our novel sarcomere modulator for HCM, towards the clinic. Over the coming months, we expect to start enrolling GRAND CANYON and a Phase 1 trial of EDG-7500 and share interim Duchenne data from our Phase 2 LYNX trial.”\n\n\nRecent Highlights\n\n\nAnnounced Positive 12-Month Topline Results from the ARCH Open Label Study of EDG-5506 in Adults with Becker\n\n\nThe Company announced positive 12-month topline results from the ongoing ARCH study, an open label, single-center study assessing the safety, tolerability, impact on muscle damage biomarkers, function and pharmacokinetics (PK) of EDG-5506 in adults with Becker. The ARCH study is evaluating varying doses of EDG-5506 administered daily over 24 months in 12 adults with Becker. The Company reported data at the end of 12 months of treatment with EDG-5506. EDG-5506 was well-tolerat...