Sarepta Gene Therapy Shipments

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Sarepta falls

In a reversal, Sarepta says it will pause shipments of gene therapy linked to deaths

By Zachary Stieber Contributing Writer In a reversal, the drugmaker Sarepta Therapeutics said July 21 it is stopping all shipments of a gene therapy that has been linked to multiple deaths. […]

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Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy

· 2d · on MSN

Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy

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InnovationRx: Sarepta Blinks In Showdown With FDA

The latest twist in the saga followed a decision by Children’s Hospital Los Angeles to halt use of the drug while it was facing regulatory uncertainty.

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Sarepta falls after gene therapy maker pauses Elevidys shipments in US

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Sarepta pares gains as report suggests an ‘arduous’ path for Duchenne drug

2don MSN

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 non-ambulatory patients after reporting to the FDA a case of acute liver failure in a patient who could not walk.

Fierce Pharma6h

FDA weighs new study requirements for Sarepta to confirm safety of gene therapy Elevidys: report

Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the company over a mounting string of controversies—to the FDA, Endpoints News reported Thursday, citing an unnamed senior FDA official.