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Sarepta resumes shipping of gene therapy Elevidys to patients who can walk
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Sarepta resumes shipping of gene therapy Elevidys to patients who can walk
Jul 28, 2025 2:45 PM

July 28 (Reuters) -

Sarepta Therapeutics ( SRPT ) said on Monday it will resume

shipping of its gene therapy Elevidys to patients with a rare

muscular disorder who can walk, after the FDA recommended the

removal of a voluntary hold that was placed on the therapy.

However, the use of the gene therapy remains on hold for

Duchenne Muscular Dystrophy patients who cannot walk, the FDA

said, adding that it is continuing to work with the company

while investigating the death of two patients.

The FDA's recommendation for ambulatory patients - those

who can walk - followed a probe that showed the death of an

eight-year-old boy in Brazil, was unrelated to the gene therapy,

the agency said.

Roche, which has partnered with Sarepta for

commercialization outside the U.S., had previously said the

patient's death was not related to the therapy, according to the

reporting physician's assessment.

Sarepta is also facing intense scrutiny following the death

of two non-ambulatory teenage boys associated with Elevidys, as

well as a 51-year-old man who had received its experimental gene

therapy SRP-9004.

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