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FDA Will Ask Sarepta to Halt Gene Therapy Shipments

BioPharma Dive · 4h

5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis

A standoff over Elevidys could have major consequences for Duchenne patients, gene therapy companies and the perception of the FDA.

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· 2d · on MSN

Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys

Fierce Pharma · 6h

Sarepta stands behind Elevidys after FDA requests gene therapy be pulled from market

10hon MSN

Sarepta extends losses premarket after refusing FDA’s halt request

Sarepta Therapeutics (SRPT) shares fell as much as 4.8% in premarket trading Monday, poised to extend losses for a second ...

4h

Sarepta Therapeutics stock sinks after FDA tells company to stop shipping its bestselling drug

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

Fierce Biotech5h

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 ...

1h

Sarepta Faces Regulatory Showdown As Analysts Cut Price Targets

Sarepta faces FDA scrutiny over Elevidys as analysts downgrade stock and warn of long-term debt risks amid market uncertainty ...

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