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Roche pauses Sarepta gene therapy shipments outside U.S.

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Roche pauses shipments of Elevidys gene therapy outside US
Roche Holding AG (ROG.S) said on Tuesday it has paused shipments of muscular disorder gene therapy Elevidys in some countries outside the U.S., echoing a similar decision by U.S. partner Sarepta Ther...

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Roche pauses Sarepta gene therapy shipments outside the U.S.
Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy
InnovationRx: Sarepta Blinks In Showdown With FDA
Last week, in a remarkable showdown, Sarepta Therapeutics refused to stop distribution of Elevidys, its therapy for the muscle-wasting disease Duchenne muscular dystrophy as the FDA had requested.

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Sarepta falls after gene therapy maker pauses Elevidys shipments in US
Sarepta Faces Fresh Setback. Why Now’s Not the Time to Buy the Stock.
Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says
But it would be difficult for Sarepta to prove that any new safety protocols could eliminate the risk of liver injuries — which have been tied to the deaths of two patients — the official added.

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Sarepta pares gains as report suggests an ‘arduous’ path for Duchenne drug
STAT · 1d
In surprise reversal, Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy
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