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EWTX 资讯
EWTX 事件
Edgewise Therapeutics Acquired by Servier for $1.55B
Edgewise Therapeutics announced the successful completion of its previously announced definitive agreement under which Servier, an independent international pharmaceutical group governed by a foundation, acquired sevasemten and Edgewise's muscular dystrophy business for $1.55B in upfront cash consideration and up to $1.1B in additional milestone payments, for aggregate potential consideration of up to $2.65B. The transaction meaningfully strengthens Edgewise's balance sheet, providing enhanced financial flexibility and sharpening the company's strategic focus to accelerate and unlock the full potential of its cardiovascular pipeline. This transaction marks Edgewise's transition to a cardiovascular-focused company, with a pipeline comprising EDG-7500 for hypertrophic cardiomyopathy, EDG-15400 for HFpEF and EDG-003 for an undisclosed target.
Edgewise Expects to Initiate Phase 3 Trial of EDG-7500 in Q4 2026
Based on recent positive 12-week data from Part D of the CIRRUS-HCM Phase 2 trial of EDG-7500, which included safety, echocardiographic, biomarker, and patient-reported outcome assessments across both oHCM and nHCM, the company is expecting to initiate a Phase 3 trial in the fourth quarter of 2026. In parallel, Edgewise remains on track to initiate a Phase 2 trial of EDG-15400 in heart failure with preserved ejection fraction, further advancing the company's cardiovascular pipeline. Additionally, the company believes the upfront proceeds from this transaction, combined with its existing cash position, will fully fund EDG-7500 development through potential approval and provide the financial strength to further build and expand its cardiovascular pipeline.
Edgewise Therapeutics Shares Drop 9.9% to $31.71
Edgewise Therapeutics is down -9.9%, or -$3.50 to $31.71.
Edgewise Therapeutics Shares Drop 25% After EDG-7500 Trial Update
Edgewise Therapeutics down 25% at $26.55 after EDG-7500 trial update
Edgewise Therapeutics Reports Positive Results for EDG-7500 Trial
Edgewise Therapeutics announced positive top-line results from the 12-week Phase 2 Part D CIRRUS-HCM trial of EDG-7500 in obstructive, or oHCM, and nonobstructive, or nHCM, nonobstructive hypertrophic cardiomyopathy, or NHC. EDG-7500 is a novel, oral, selective cardiac sarcomere modulator designed to slow early contraction velocity and improve impaired cardiac relaxation in symptomatic HCM without compromising systolic function. To date, in over 700 echocardiograms performed in healthy adults and patients with HCM, there was no relationship observed between multiple measures of systolic function and concentration of EDG-7500. Patients with oHCM receiving EDG-7500 demonstrated broad and clinically meaningful responses across key measures of hemodynamics, biomarkers, patient-reported health status and functional status. Consistent with previous findings, significant reductions in LVOT-G were observed at rest and post Valsalva, with 90% of patients demonstrating improvement in hemodynamic measures. In a key measure of heart failure severity, 74% of patients achieved either normalization of NT-proBNP levels or a greater than or equal to 50% reduction from baseline. In addition, administration with EDG-7500 led to a ~20% mean increase in early diastolic mitral annular velocity, a marker of diastolic function. In a preliminary high frame rate sub-study, E/e' improved by a mean of 5.3 points, suggestive of markedly improved diastolic function. EDG-7500 was generally well tolerated in Part D patients and there were no new safety signals identified. Nearly all AEs were considered mild to moderate in severity. There were no meaningful changes in left ventricular ejection fraction, or LVEF, or reductions in LVEF to below 50%. Data from CIRRUS-HCM support advancing EDG-7500 into Phase 3 clinical development, with program initiation targeted for Q4.
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