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Sarepta falls after gene therapy maker pauses Elevidys shipments in US
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Sarepta falls after gene therapy maker pauses Elevidys shipments in US
Jul 22, 2025 6:56 AM

July 22 (Reuters) - Shares of Sarepta Therapeutics ( SRPT )

fell nearly 7% on Tuesday after the company agreed to

comply with the U.S. health regulator's request to pause all

shipments of its gene therapy Elevidys in the United States.

The U.S. Food and Drug Administration on Friday asked

Sarepta to voluntarily halt shipments of the gene therapy, but

the company refused to do so and said it would continue making

the treatment available to ambulatory patients.

But Sarepta has now voluntarily and temporarily paused all

shipments of the therapy, effective end of Tuesday. The company

said the decision would allow it to respond to requests from the

FDA and maintain a positive relationship with the agency.

"Though Sarepta claims its pause in shipments was voluntary,

we think the company moved preemptively - bracing for an

inevitable FDA mandate to pull the drug," said H.C. Wainwright

analyst Mitchell Kapoor.

Shares of Sarepta fell 6.9% to $12.40 in early trading on

Tuesday.

"Sarepta's decision to comply was a capitulation after

recognizing that the fight with the FDA was not winnable and

that the agency would have strong-armed Sarepta into removing

Elevidys with a formal demand," Kapoor added.

Investor concerns regarding the use of the company's

treatments have been heightened after the company on Friday

disclosed that another patient who had received its experimental

gene therapy died from acute liver failure, marking the third

death this year.

The company's shares have plummeted 89% so far this year.

On Monday, Children's Hospital Los Angeles said it had

paused usage of Elevidys in all patients with muscular

dystrophy.

The FDA's initial request had likely heightened the pressure

on physicians to pause treatments, which could also have been a

driving factor in Sarepta's decision, William Blair analyst Sami

Corwin said.

(Reporting by Sriparna Roy in Bengaluru; Editing by Shinjini

Ganguli)

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