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)