Overview

• The FDA formally asked Sarepta to suspend all Elevidys shipments and placed its limb-girdle muscular dystrophy trials on hold.
• Sarepta declined to comply with the FDA request and continues to supply Elevidys to younger ambulatory patients.
• The company updated its packaging this week to include a prominent warning about acute liver injury and failure.
• Sarepta announced the layoff of nearly 500 employees, including 80 in central Ohio, as regulatory pressure intensifies.
• Investors drove Sarepta shares down over 30% on worries about Elevidys’ safety profile and commercial outlook.