Sarepta Halts Elevidys Shipments Amid Safety Concerns

CAMBRIDGE, Massachusetts — Sarepta Therapeutics, Inc. announced on Monday that it will voluntarily pause all U.S. shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, as it seeks to address safety concerns.

This decision comes after the Food and Drug Administration (FDA) requested a halt to distribution due to safety issues linked to patient deaths. Initially, Sarepta refused to comply with the FDA’s request but later reversed its decision.

The suspension allows for a necessary update to safety labeling, which will include a black box warning for acute liver injury. Bank of America (BofA) Securities has downgraded Sarepta’s stock from Neutral to Underperform, noting increased volatility following the announcement.

BofA analyst Tazeen Ahmad indicated that the firm had spoken with Sarepta’s president and CFO, Ian Estepan, who stated that the company has requested a meeting with the FDA to discuss the situation further. Sarepta is currently awaiting a response to its updated label submission, which could clarify the timeline for the pause.

The controversy surrounding Elevidys could further damage its reputation, especially following extensive media coverage. Analysts at BofA caution that there is a risk Elevidys could be pulled from the U.S. market altogether. As a precaution, BofA has removed Elevidys, which is valued at $16 per share, from its financial model.

Despite a previous plan to continue shipping Elevidys to younger patients, Sarepta decided to comply with the FDA to foster a better relationship with the agency. BofA has praised this decision but will continue to monitor regulatory feedback closely.

As of Wednesday, Sarepta Therapeutics shares were up 0.92%, trading at $13.74.