Sarepta Elevidys Shipment Controversy

News

Sarepta can begin shipping Elevidys therapy

Sarepta can begin shipping Elevidys therapy after FDA reverses pause; stock soars.

Sarepta ( SRPT) will begin shipping its top-selling muscular dystrophy therapy, Elevidys, after the U.S. Food and Drug Administration (FDA) reversed its request for a voluntary pause late Monday.

Reuters on MSN · 13h

Sarepta resumes shipping of gene therapy Elevidys to patients who can walk

Sarepta Therapeutics 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.

Fierce Pharma · 7d

Sarepta stands behind Elevidys after FDA requests gene therapy be pulled from market

As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm behind its approved Duchenne muscular dystrophy (DMD) treatment. | As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head,

Sarepta Therapeutics stock sinks further Tuesday after halting shipment of bestselling drug Elevidys

Sarepta stock tanked Friday after a new patient death was uncovered, spurring an FDA request to halt shipments of an ...

MIT Technology Review4d

The deadly saga of the controversial gene therapy Elevidys

The drug, which was designed to treat Duchenne muscular dystrophy, has been linked to the deaths of two teenage boys.

BioSpace6d

Lack of Transparency Tarnishes Sarepta’s Sheen as Patient Deaths Trigger FDA Battle

Sarepta Therapeutics’ stock has dropped precipitously as questions swirl around the safety of its gene therapies. Meanwhile, ...

3don MSN

Sarepta falls as FDA plans to investigate death of child who received Elevidys

The U.S. Food and Drug Administration said on Friday that it is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta Therapeutics ( NASDAQ: SRPT) gene therapy for Duchenne ...

FiercePharma1mon

2nd patient dies after Sarepta's DMD gene therapy Elevidys

A second patient has died following treatment with Sarepta Therapeutics’ Elevidys, raising more doubts about the Duchenne muscular dystrophy (DMD) gene therapy’s safety profile.

BioSpace3d

Sarepta Fallout Continues With EU’s Negative Opinion of Elevidys in Ambulatory Patients

The European Union’s health regulatory agency did not endorse approving Elevidys for ambulatory patients with Duchenne ...

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