Overview

• The FDA has formally asked Sarepta to voluntarily stop all Elevidys shipments in response to emerging safety signals.
• Sarepta has refused the FDA’s request and will continue limited distribution to ambulatory Duchenne patients with newly added liver-injury warnings.
• Earlier this year, two teenage boys died of acute liver failure after receiving Elevidys, and a third patient died in a related limb-girdle muscular dystrophy trial.
• The company suspended shipments to non-ambulatory patients and is subject to a clinical hold on limb-girdle studies during the FDA investigation.
• Facing threats to its leading revenue source, Sarepta has laid off nearly 500 employees as regulators weigh Elevidys’s future.