Edgewise Therapeutics has completed the sale of sevasemten and its muscular dystrophy business to Servier, an independent international pharmaceutical group, for $1.55 billion in upfront cash and up to $1.1 billion in additional regulatory and commercial milestone payments, representing aggregate potential consideration of up to $2.65 billion. The transaction, advised by Centerview Partners as exclusive financial adviser and Wilson Sonsini Goodrich & Rosati as legal counsel, marks Edgewise’s transition into a focused cardiovascular company with a pipeline centered on EDG-7500 for hypertrophic cardiomyopathy, EDG-15400 for heart failure with preserved ejection fraction, and EDG-003 for an undisclosed target.
Under the terms of the agreement, Servier acquired all rights to sevasemten, including related intellectual property, know-how, key agreements, regulatory filings, and clinical data required to operate the muscular dystrophy business. Edgewise employees primarily supporting the muscular dystrophy program received offers to transition to Servier, ensuring continuity of development and future commercial execution.
Sevasemten is a novel small molecule designed to selectively limit excessive muscle damage resulting from the absence or loss of functional dystrophin, targeting both Becker and Duchenne muscular dystrophy. The asset has demonstrated sustained disease stabilization across more than three years of treatment in clinical studies: in the MESA open-label extension, participants maintained stable North Star Ambulatory Assessment scores in marked contrast to the functional decline expected from natural history data. Sevasemten has secured FDA Orphan Drug Designation and Rare Pediatric Disease Designation for Duchenne, Fast Track designations for both Becker and Duchenne, and EMA Orphan Drug Designations for both indications. If approved, it would be the first therapy indicated specifically for Becker muscular dystrophy, a rare X-linked neuromuscular disorder affecting approximately 12,000 individuals across the US, EU-5, and Japan. The GRAND CANYON pivotal cohort in Becker is fully enrolled, with 175 participants, and is powered at greater than 98% to detect a statistically significant difference versus placebo, with top-line data expected in the fourth quarter of 2026.
For Edgewise, the $1.55 billion in upfront proceeds, combined with existing cash, is expected to fully fund EDG-7500 development through potential regulatory approval. EDG-7500 is a cardiac myosin inhibitor being developed for hypertrophic cardiomyopathy across both obstructive and non-obstructive forms, and recently generated positive 12-week data from Part D of the CIRRUS-HCM Phase 2 trial covering safety, echocardiographic, biomarker, and patient-reported outcome assessments. Based on those results, Edgewise plans to initiate a Phase 3 trial in the fourth quarter of 2026. In parallel, the company remains on track to initiate a Phase 2 trial of EDG-15400 in HFpEF, further advancing a cardiovascular portfolio designed to address significant unmet medical need in large and underserved patient populations.
Servier frames the acquisition as a strategic milestone in its “Servier 2030” plan to become a new player in rare neurology and to serve patients with devastating rare diseases, highlighting Edgewise’s pioneering work in muscle disease biology and its track record of discovering and developing precision therapies for serious neuromuscular conditions.
KEY QUOTES:
“Completing this transaction with Servier marks an important milestone for Edgewise and for the sevasemten program. I want to thank the many colleagues whose dedication and expertise have advanced sevasemten to this point; this progress would not have been possible without their contributions. We’re confident Servier’s global scale, deep expertise in rare diseases, and commitment to patients will help fully realize sevasemten’s potential for individuals living with Becker and Duchenne muscular dystrophy. This transaction also strengthens our balance sheet and provides the financial flexibility to advance EDG-7500 and EDG-15400 through key value-inflection points.”
Kevin Koch, Ph.D., President and CEO, Edgewise Therapeutics
“Edgewise is a pioneer in muscle disease biology with a proven track record of discovering and developing precision therapies for patients with serious neuromuscular conditions. With the successful closing of this acquisition, we are pleased to welcome a highly experienced team and a strong ambition in Becker and Duchenne muscular dystrophy to Servier. This is a strategic milestone in achieving Servier 2030 to become a new player in rare neurology and to serve patients living with devastating rare diseases.”
Olivier Laureau, President, Servier
