Sarepta falls after gene therapy maker pauses Elevidys shipments in US

Audio By Carbonatix

By Sriparna Roy

(Reuters) -Shares of Sarepta Therapeutics fell as much as 8% 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.

Stat News reported on Tuesday, citing an FDA official, that it could be difficult for Sarepta to bring the treatment back to the market.

The agency had an internal plan in place to request Elevidys be pulled from the market if a third death occurred, the report said, citing the official.

The Department of Health and Human Services, which oversees the FDA, did not immediately respond to a request for comment.

“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.

The FDA’s request came 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.

Shares of Sarepta have plummeted 89% so far this year, wiping out more than $10 billion from the company’s market value, weighed by concerns regarding the use of its treatments.

(Reporting by Sriparna Roy in Bengaluru; Additional reporting by Mariam Sunny; Editing by Shinjini Ganguli)