Overview

• Following an FDA request on Friday, Sarepta agreed Monday to temporarily pause all Elevidys shipments by the close of business Tuesday.
• The decision reverses the company’s initial refusal to halt distribution to ambulatory patients after a third patient death linked to its gene therapies.
• The FDA placed clinical holds on Sarepta’s limb-girdle muscular dystrophy trials, demanding a black box warning for Elevidys.
• Children’s Hospital Los Angeles and other treatment centers have suspended dosing and canceled scheduled infusions as regulators complete safety reviews.
• Sarepta’s share price has plunged over 35% recently, and analysts at Mizuho, Needham and Piper Sandler have cut ratings and price targets amid mounting revenue risk.