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Sarepta, FDA and gene

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Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy
Shares of drugmaker Sarepta Therapeutics continued to fall Tuesday after the company said it would comply with a Food and Drug Administration request to pause shipments of its gene therapy following several patient deaths.

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Fierce Pharma · 2d
Sarepta stands behind Elevidys after FDA requests gene therapy be pulled from market
Sarepta Therapeutics says it will pause shipments of Duchenne 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
Fierce Biotech2d
Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy
The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb-girdle muscular dystrophy (LGMD) trials, while also revoking the biopharma’s gene therapy platform technology designation.
Sarepta Therapeutics: Why Is SRPT Stock Crashing?
The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.
STAT5d
Sarepta Therapeutics crisis is huge blow to Duchenne families, company
The FDA will request Sarepta Therapeutics stop all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, following two deaths tied to the product.
Friday's movers: Sarepta, Norfolk Southern, Netflix and more
These were the most active stocks ahead of Friday's market open: Sarepta Therapeutics Inc.'s stock tumbled 27% after the company said another patient died following gene-therapy treatment, Bloomberg reported,
Sarepta shares slump after report of patient death in early-stage study
Shares of Sarepta Therapeutics declined 16.5% to $18.32 in premarket trading on Friday after a Bloomberg report that a patient enrolled in an early-stage study of one of the company's gene therapies has died from acute liver failure.
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