– CIRRUS-HCM 12-week data of EDG-7500 in obstructive and nonobstructive hypertrophic cardiomyopathy (HCM) expected in Q2 2026,
– Pivotal GRAND CANYON results for sevasemten in Becker expected in Q4 2026,
BOULDER, Colo., May 7, 2026 /PRNewswire/ -- Edgewise Therapeutics, Inc. (NASDAQ:EWTX), a leading muscle disease biopharmaceutical company, today reported financial results for the first quarter of 2026 and recent business highlights.
"For the first time with an investigational agent, we have generated long-term data showing that people with Becker remain stable despite a disease that typically leads to significant functional decline," said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise. "We remain on track to report pivotal top-line data from GRAND CANYON evaluating sevasemten, which has the potential to support our first marketing application in Becker. We also anticipate results this quarter from CIRRUS-HCM 12-week Part D evaluating EDG-7500 in HCM, which will help refine our Phase 3 strategy. With multiple near-term catalysts and a highly focused team, we are well positioned to advance our programs and deliver potentially transformative therapeutic options for patients facing serious muscle diseases facing high unmet need."
Recent Highlights
Muscular Dystrophy Program
MESA open-label extension trial in adults with Becker:
MESA is an open-label extension study evaluating sevasemten long-term safety, tolerability, and efficacy in adults and adolescents with Becker previously treated in sevasemten clinical trials. Nearly all eligible participants (99%) from prior sevasemten studies (including ARCH, DUNE and CANYON/GRAND CANYON) chose to enroll in the MESA open-label extension study.
At the 2026 MDA Clinical and Scientific Conference, the Company presented long-term data from MESA showing participants on sevasemten experienced stabilization of function up to 3.5 years in marked contrast to the functional decline expected from Becker natural history data. The data reinforce prior clinical findings of sevasemten in Becker, a rare disease with no approved treatments. The results can be found here. The Company also presented a poster with new analysis from the CANYON study showing sevasemten had a well-tolerated cardiac profile over 12 months, with no adverse effects on left ventricular ejection fraction (LVEF) or NT‑proBNP and evidence of LVEF improvement in certain subgroups, with positive trends observed across all adult participants versus placebo. The poster can be viewed here. To learn more about MESA or CANYON, go to clinicaltrials.gov (MESA: NCT06066580, CANYON (NCT05291091).
GRAND CANYON, a global pivotal placebo-controlled cohort in Becker: GRAND CANYON is designed to assess the efficacy and safety of sevasemten over an 18-month period, with North Star Ambulatory Assessment (NSAA) as the primary endpoint. The study is highly powered to be able to show a statistically significant difference in NSAA versus placebo over 18 months. The Company expects to report top-line data in the fourth quarter of 2026 and is continuing preparations for a potential marketing application to seek approval as the first targeted therapy for this underserved population, planned for the first half of 2027. To learn more about GRAND CANYON, go to clinicaltrials.gov (NCT05291091).
LYNX and FOX Phase 2 placebo-controlled trials in boys with Duchenne: LYNX is designed to evaluate the effect of sevasemten on safety, biomarkers of muscle damage and function in boys with Duchenne in a placebo-controlled dose ranging study, followed by an open-label extension period. FOX is designed to evaluate the effect of sevasemten on safety, biomarkers of muscle damage and function in children and adolescents with Duchenne who have been previously treated with gene therapy. The Company continues to collect longer-term data in the open-label extension portion of these Phase 2 programs to inform the future clinical studies in Duchenne. For more information, go to clinicaltrials.gov to learn more about LYNX (NCT05540860) and FOX (NCT06100887).
Cardiovascular Programs
CIRRUS-HCM Phase 2 trial in adults with symptomatic HCM: The Company is advancing CIRRUS-HCM, a multi-part, open-label trial, in participants with HCM at over 20 clinical sites in the U.S. Part A of the trial evaluated the safety and tolerability of a single oral dose of EDG-7500 in participants with obstructive HCM (oHCM). Parts B and C evaluated fixed doses of EDG-7500 over 28 days in oHCM and nonobstructive HCM (nHCM), respectively. The results can be found here. Part D is a 12-week study with an open-label extension including participants with oHCM and nHCM designed to explore dose response and optimization. The Company plans to report 12-week Part D data (oHCM and nHCM) in the second quarter of 2026 and initiate Phase 3 in the second half of 2026. To learn more about CIRRUS-HCM, visit clinicaltrials.gov, NCT06347159.
EDG-15400 and heart failure: EDG-15400 is a novel oral, selective, cardiac sarcomere modulator, targeted for the treatment of heart failure and other diseases of diastolic dysfunction. EDG-15400 is currently being evaluated in healthy adults in a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study evaluating safety, tolerability, pharmacokinetics and ...
