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FDA, Sarepta and gene therapy

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.

Fierce Pharma · 8h

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

· 2d · on MSN

Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths

Sarepta stock extends decline

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· 6h

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 unrelated drug.

· 13h · on MSN

Sarepta stock extends decline as company declines FDA call to withdraw drug

Investor's Business Daily on MSN · 2h

Sarepta's 'Unprecedented Times' Continue As Company Rebukes The FDA

7hon MSN

BMO's Kostas Biliouris: It will be challenging for the FDA to force a market withdrawal for Sarepta

Kostas Biliouris, BMO Capital Markets biotech analyst, joins CNBC's 'Squawk on the Street' to discuss the latest details on ...

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 ...

Sarepta Therapeutics: Why Is SRPT Stock Crashing?

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

STAT6hOpinion

We are mothers of Duchenne patients. Recent setbacks with Sarepta must not stop progress

As mothers of children with this disease, we have wept helplessly in recent months as friends — fellow members of a club we ...

2hon MSN

These Stocks Are Moving the Most Today: Sarepta, Verizon, Cleveland-Cliffs, Block, Tesla, DJT, Bruker, and More

Stocks were rising Monday as Wall Street monitored the latest trade developments, digested a number of earnings reports, and ...

Hoodline1d

Sarepta Therapeutics Announces Layoff of 493 Employees, Including 80 in Ohio, Amid FDA Scrutiny and Stock Decline

Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.

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FDA

Food and Drug Administration

Elevidys

Gene therapy

SRP-9004

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