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FDA, Sarepta Therapeutics and Duchenne

Sarepta Therapeutics laying off dozens in Ohio, won't comply with FDA request to halt therapy

U.S. regulators recently asked Sarepta Therapeutics to voluntarily halt shipments of its Elevidys gene therapy after a muscular dystrophy patient who received a different, experimental treatment died...

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Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says

· 1d · on MSN

Sarepta’s Duchenne Therapy Sparked Fears Even Before FDA’s Order

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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 Faces Fresh Setback. Why Now’s Not the Time to Buy the Stock.

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In surprise reversal, Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy

Sarepta stops Elevidys shipments

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· 1d · on MSN

Sarepta Changes Course, Agrees to Pause Elevidys Shipments

Sarepta Therapeutics Inc. announced that the company plans to temporarily pause all shipments of its gene therapy to treat Duchenne muscular dystrophy, Elevidys, in a reversal of its prior stance.

· 10h · on MSN

Roche pauses shipments of Elevidys gene therapy outside US

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Sarepta stops Elevidys shipments after standoff with FDA

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Elevidys Halt Sparks Analyst Downgrades—Sarepta Races To Revise Label

Analysts downgraded Sarepta as FDA pause on Elevidys raises regulatory uncertainty, leading to significant stock pressure and valuation cuts.

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Pharmalittle: We’re reading about Sarepta’s ‘arduous’ path ahead, pharma’s reliance on China, and more

Sarepta faces an “arduous and treacherous path” to try to get its Duchenne muscular dystrophy therapy Elevidys back onto the market

Fierce Pharma5h

Roche halts Elevidys distribution in some countries, following Sarepta's lead in US

Roche is pausing shipments of Elevidys in some countries, following partner Sarepta Therapeutics’ move in the U.S., as safety concerns mount over the Duchenne muscular dystrophy gene therapy. | Roche is pausing shipments of Elevidys in some countries,

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Arrowhead expects Sarepta to honor financial obligations

Arrowhead Pharmaceuticals (ARWR) stock gains as company reassures investors about financial obligations required from Sarepta (SRPT) under a 2025 deal. Read more here.

Sarepta Therapeutics: Why Is SRPT Stock Crashing?

The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.

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Sarepta’s Elevidys Halted at Children’s Hospital Los Angeles

Children’s Hospital Los Angeles paused the use of Sarepta Therapeutics Inc.’s gene therapy for Duchenne muscular dystrophy in the wake of rising safety concerns about liver toxicity, adding to mounting challenges for the drugmaker.