Sarepta Gene Therapy Setbacks

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Sarepta, Gene Therapy

Sarepta's Setback Deepens With Another Gene Therapy Fatality

In response to these safety concerns, the U.S Food and Drug Administration (FDA) has requested that the label include a black box warning for acute liver injury (ALI) and acute liver failure (ALF), a...

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

STAT · 1d

Pharmalittle: We’re reading about a GSK setback, another Sarepta gene therapy death, and more

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

Drugmaker Sarepta Therapeutics said late Friday it won't comply with a request from the Food and Drug Administration to halt all shipments of its gene therapy following the death of a third patient r...

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FDA prepares to ask Sarepta Therapeutics to stop all shipments of Duchenne muscular dystrophy therapy

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FDA to ask Sarepta to stop shipping Duchenne gene therapy

3don MSN

Sarepta to cut 500 jobs after gene therapy setback, shares jump

Sarepta Therapeutics said on Wednesday it would lay off 36% of its workforce, or about 500 employees, after the recent deaths of two patients who had received its gene therapy Elevidys. Its shares shot up about 40% in extended trading,

Sarepta: Despite Restructuring, Downgrading To Sell After Latest Developments

The restructuring enacted by Sarepta Therapeutics is expected to save up to $400 million in annual costs. Read why I'm downgrading SRPT stock from Hold to Sell.

Fierce Pharma5d

Ultragenyx takes another hit as FDA snubs AAV gene therapy over manufacturing issues

The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new FDA leadership’s much-touted support for cell and gene therapies against rare diseases.

3don MSN

Sarepta to cut 500 jobs, add black-box warning on gene therapy

Sarepta Therapeutics will cut 500 jobs and add a serious warning on the label of its muscle-disorder gene therapy Elevidys, the drugmaker said on Wednesday, following the recent deaths of two patients who were on the medicine.