Sarepta Therapeutics Deaths

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Sarepta falls

Sarepta Needs to Show FDA Elevidys Won’t Cause More Deaths

The Food and Drug Administration won’t sign off on Sarepta Therapeutics Inc. bringing its controversial gene therapy back to the market until the company can persuade US regulators that it won’t cause more deaths,

Seeking Alpha on MSN · 12h

Sarepta falls as FDA plans to investigate death of child who received Elevidys

The U.S. Food and Drug Administration said on Friday that it is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta Therapeutics ( NASDAQ: SRPT) gene therapy for Duchenne muscular dystrophy. The death occurred on June 7, 2025.

The Boston Globe · 6d

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

In a highly unusual move, Cambridge-based Sarepta said late Friday won’t comply with a request from the Food and Drug Administration to halt all shipments of its gene therapy.

6don MSN

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

Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...

3don MSN

In a reversal, Sarepta says it will pause shipments of gene therapy linked to deaths

By Zachary Stieber Contributing Writer In a reversal, the drugmaker Sarepta Therapeutics said July 21 it is stopping all ...

1don MSN

Sarepta drops as report suggests FDA needs new trials for Elevidys

Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...

3don MSN

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

Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...

Fierce Pharma1d

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 ...

BioPharma Dive21h

Sarepta woes mount as Duchenne gene therapy knocked back in Europe

The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could ...

Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy

Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s ...

STAT2d

Pharmalittle: We’re reading about Sarepta’s ‘arduous’ path ahead, pharma’s reliance on China, and more

Sarepta faces an “arduous and treacherous path” to try to get its Duchenne muscular dystrophy therapy Elevidys back onto the ...

Investor's Business Daily on MSN14h

Sarepta Therapeutics' Brutal Week Continues With Bad News Out Of Europe

Sarepta Therapeutics'SRPT brutal week continued Friday after European officials rejected the company's controversial gene therapy, Elevidys.The rejection, which was delivered to European partner ...

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