sarepta duchenne muscular dystrophy

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Sarepta's Duchenne Therapy Sparked Fears

Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy

Sarepta Therapeutics said Monday evening it will pause all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, acceding to a request made by the Food and Drug Administration afte...

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

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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 falls after gene therapy maker pauses Elevidys shipments in US

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

PharmExec2h

Recapping the Sarepta Saga—And Implications for Industry

A timeline of key developments surrounding Sarepta Therapeutics' Duchenne muscular dystrophy drug Elevidys, and the potential future impacts for gene therapy regulation and market access.

2hon MSN

Sarepta Needs to Show FDA Elevidys Won’t Cause More Deaths

The Food and Drug Administration won’t sign off on Sarepta Therapeutics Inc. bringing its controversial gene therapy back to the market until the company can persuade US regulators that it won’t cause more deaths,

BioSpace12h

Following Sarepta’s Lead, Roche Suspends Elevidys Shipments to Some Ex-US Countries

Discovered and developed by Sarepta Therapeutics, Elevidys is a gene therapy that won accelerated approval in June 2023 and full approval in June 2024. Roche partnered with Sarepta in December 2019, paying $1.15 billion upfront in cash and stock for the right to launch and market Elevidys outside the U.S.

Sarepta stock faces multiple downgrades and questions of solvency amid Elevidys pause

For Sarepta, the hits keep coming, with several downgrades in the past week after it was forced to temporarily take its top-selling drug off the market.

2don MSN

FDA Suspends Muscular Dystrophy Drug After 3 Patient Deaths

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational gene therapy trials for limb girdle muscular dystrophy following three patient deaths potentially linked to the company's treatments.

BioSpace13h

Sarepta’s Wild Week, CDER’s New Leader, FDA Rejections, Manufacturing Billions

Sarepta Therapeutics faces serious FDA action after news broke of a third patient death, the FDA gets a new top drug regulator in George Tidmarsh, a handful of new drugs get turned away from the market and pharma companies continue to commit billions to reshoring manufacturing.

5hon MSN

Sarepta cut to Underperform at BofA on Elevidys concerns

Bank of America downgraded Sarepta Therapeutics (NASDAQ:SRPT) to Underperform from Neutral on Wednesday, becoming the latest brokerage to issue a bearish view on the company, citing safety concerns related to its Elevidys gene therapy marketed with Roche (OTCQX:RHHBY).