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Sarepta Stock Falls. Why It’s Caving Into the FDA and What Comes Next.
The company agreed to voluntarily halt shipments of its experimental medicine Elevidys for Duchenne muscular dystrophy.
STAT42m
In surprise reversal, Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy
Sarepta will halt all shipments of Elevidys, its drug for Duchenne muscular dystrophy patients, by Tuesday evening.
Sarepta to pause Elevidys gene therapy shipments in US
Sarepta Therapeutics said on Monday it will pause all shipments of Elevidys in the United States after two teenage boys with a rare condition called Duchenne muscular dystrophy, who had received the ...
Children's Hospital LA pauses use of Sarepta gene therapy for all patients
Children's Hospital Los Angeles, citing recent U.S. Food and Drug Administration actions, on Monday said it has paused usage of Sarepta Therapeutics' gene therapy Elevidys in all patients with ...
Drugmaker declines FDA request to pull treatment after patient deaths
By Zachary Stieber Contributing Writer Sarepta Therapeutics will not agree to a regulatory request to pause shipments of a ...
BioPharma Dive14h
FDA asks Sarepta to stop shipping Duchenne gene therapy
The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still ...
Sarepta Therapeutics laying off dozens in Ohio, won't comply with FDA request to halt therapy
After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy to ambulatory people but maintain a halt it implemented June 15 for ...
MyChesCo on MSN16h
FDA Shuts Down Sarepta Gene Therapy Trials After Three Deaths Linked to Liver Failure
The U.S. Food and Drug Administration on Friday placed Sarepta Therapeutics’ gene therapy trials for limb girdle muscular ...
MedPage Today17h
Drugmaker Refuses FDA's Request to Pull Gene Therapy Tied to Patient Deaths
The agency also revoked Sarepta's platform technology designation for AAVrh74 Friday and issued a safety communication saying ...
BioPharma Dive17h
5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis
A standoff over Elevidys could have major consequences for Duchenne patients, gene therapy companies and the perception of ...
MPR17h
Third Death Prompts FDA Action on Sarepta’s Gene Therapy Products
The third death occurred in an adult male with limb girdle muscular dystrophy who received a Sarepta AAVrh74 gene therapy product, SRP-9004, in a phase 4 clinical trial.
Precision Medicine Online18h
Sarepta to Continue to Ship Duchenne Gene Therapy Elevidys Despite FDA Request
The FDA requested Sarepta voluntarily stop distributing Elevidys after the death of a third patient who received one of the firm's gene therapies.