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Sarepta Therapeutics, FDA and Duchenne

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.

STAT · 2h

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

Sarepta Therapeutics faces an "arduous path” to try to get its gene therapy for Duchenne muscular dystrophy back onto the market, a senior FDA official told STAT.

Seeking Alpha on MSN · 1h

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

Sarepta Therapeutics ( NASDAQ: SRPT) faces an “arduous and treacherous path” to bring its gene therapy Elevidys back to market, according to a STAT report citing a senior FDA official, suggesting the treatment’s license could be revoked amid ongoing safety concerns.

20hon 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 ...

Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy

Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s ...

Sarepta falls after gene therapy maker pauses Elevidys shipments in US

Shares of Sarepta Therapeutics fell nearly 7% on Tuesday after the company agreed to comply with the U.S. health regulator's request to pause all shipments of its gene therapy Elevidys in the United ...

GEN - Genetic Engineering and Biotechnology News19h

About Face: Sarepta to Pause Elevidys Shipments Temporarily

Sarepta Therapeutics said it will voluntarily “and temporarily” pause all shipments of Elevidys® (delandistrogene ...

GlobalData on MSN10h

Sarepta halts Elevidys shipments following FDA pressure

Sarepta CEO Doug Ingram said it is important the company maintains a “positive working relationship” with the FDA.

Sarepta Reverses Course, Pauses Elevidys Shipments Amid FDA Safety Review

Sarepta pauses U.S. Elevidys shipments to complete FDA-requested safety label updates, aiming to resume distribution in the fourth quarter.

9hon MSN

Sarepta Therapeutics stock sinks further Tuesday after halting shipment of bestselling drug Elevidys

Sarepta stock tanked Friday after a new patient death was uncovered, spurring an FDA request to halt shipments of an unrelated drug.

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