Sarepta Gene Therapy Precedent

News

Sarepta, FDA and gene therapy

FDA weighs new study requirements for Sarepta to confirm safety of gene therapy Elevidys: report

Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the company over a mounting string of controversies—to the FDA, Endpoints News and Bloomberg separately reported Thursday, citing an unnamed senior FDA official.

BioPharma Dive · 5d

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

· 18h · on MSN

Sarepta fails to win EU backing for muscle disorder gene therapy

Investor's Business Daily on MSN1d

The Hits Keep Coming For Sarepta. Why Its Latest Setback Creates A 'Dangerous Precedent.'

Sarepta stock plunged again Thursday on a report the FDA will require additional clinical testing to validate the safety ...

PharmExec2d

Recapping the Sarepta Saga—And Implications for Industry

A timeline of key developments surrounding Sarepta Therapeutics' Duchenne muscular dystrophy drug Elevidys, and the potential ...

Fierce Biotech9d

Sarepta pivots to siRNA and lays off 500 staffers as Elevidys gets box warning

Sarepta Therapeutics is laying off 500 staffers, or 36% of its workforce, as part of a strategic restructuring aiming to save $400 million annually. | Sarepta Therapeutics has laid off 500 staffers, ...

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 ...

Reuters1mon

Sarepta shares crash as second patient dies after receiving its gene ...

Shares of Sarepta Therapeutics closed down as much as 42% to hit a nine-year low of $18.30 on Monday after a second death of a male teenage patient who had received its gene therapy, Elevidys ...

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