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Sarepta, FDA and gene

Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy

Shares of drugmaker Sarepta Therapeutics continued to sink Tuesday after the company said it would comply with a Food and Drug Administration request to pause shipments of its gene therapy following s...

· 11h · on MSN

Sarepta Therapeutics’ stock slips further as company bows to FDA pressure to halt shipments

· 2d · on MSN

Sarepta’s Risky Gamble: Gene Therapy Stays on Market Despite FDA Request

· 9h

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

Sarepta Therapeutics was falling again in premarket trading Tuesday as its future looks increasingly shaky after it agreed to halt shipments of its Elevidys drug under pressure from the Food and Drug ...

STAT · 13h

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

STAT · 1d

Pharmalittle: We’re reading about Sarepta resisting FDA over Elevidys, agency naming top drug regulator, and more

STAT3h

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.

Fierce Biotech1d

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.

BioSpace7h

Lack of Transparency Tarnishes Sarepta’s Sheen as Patient Deaths Trigger FDA Battle

Sarepta Therapeutics’ stock has dropped precipitously as questions swirl around the safety of its gene therapies. Meanwhile, the Duchenne patient community fears losing access to Elevidys while the regulator considers more drastic action.

STAT8h

Pharmalittle: We’re reading about Sarepta conceding to the FDA, the U.S. transplant system, and more

Sarepta Therapeutics reversed course and agreed to halt all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy

Investor's Business Daily on MSN1d

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

Sarepta stock took another dive Monday after the biotech company refused the FDA's request to voluntarily stop all shipments of Elevidys.