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FDA Will Ask Sarepta to Halt Gene Therapy Shipments

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Exclusive-US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says
By Bhanvi Satija (Reuters) -The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop all shipments of its gene therapy Elevidys, a source familiar with the matter told Reuters on Friday.

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Sarepta Refused FDA’s Request to Halt Elevidys Shipments
Southwest Journal · 17h
Breaking: Second Patient Death Prompts FDA Investigation of Sarepta’s Elevidys Gene Therapy
FDA prepares to ask Sarepta Therapeutics to stop all shipments of Duchenne muscular dystrophy therapy
A 51-year-old man died last month after receiving an experimental gene therapy developed by Sarepta Therapeutics for an ultra-rare form of muscular dystrophy, a company spokesperson confirmed Thursda...

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Exclusive: US FDA to request Sarepta to stop all shipments of gene therapy Elevidys, source says
FDA to ask Sarepta to stop shipping Duchenne gene therapy
Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys
FDA Commissioner Marty Makary told Bloomberg News in an interview that he was "taking a hard look" at whether a gene therapy from Sarepta should remain on the market.

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Sarepta's Setback Deepens With Another Gene Therapy Fatality
Becker's Hospital Review · 14h
Sarepta reports 3rd patient death after gene therapy treatment
STAT5h
Sarepta Therapeutics crisis is huge blow to Duchenne families, company
The FDA will request Sarepta Therapeutics stop all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, following two deaths tied to the product.
BioPharma Dive3h
Sarepta reports patient death in limb-girdle trial, compounding concerns on gene therapy risks
The death of a 51-year-old man in the study follows two other deaths of Duchenne patients treated with Sarepta’s marketed gene therapy Elevidys.
Fierce Biotech14h
UPDATED: Analysts demand transparency after Sarepta's roundabout disclosure of 3rd patient death
On an investor call Friday, analysts grilled the company over its apparent lack of transparency on the matter.
Gene-therapy company to eliminate 21 Durham employees as part of major restructuring
Massachusetts-based Sarepta Therapeutics, facing scrutiny from regulators, is reducing its global workforce by 36% in an effort to cut annual operating costs by hundreds of millions of dollars.
Sarepta Therapeutics Provides Statement on ELEVIDYS
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the following statement:
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Sarepta Therapeutics Stock Plunges Over 30% In Friday Pre-Market: What's Going On
Shares of Sarepta Therapeutics (NASDAQ: SRPT) plunged 26.85% in Friday pre-market after a clinical trial participant died following treatment with a gene therapy, marking the third death linked to the company's experimental treatments.
Sarepta: Safety And Efficacy Flaws Undermine Gains On Restructuring News
Sarepta Therapeutics, Inc. faces setbacks with Elevidys, safety issues, and workforce cuts, raising concerns about its outlook. Click for my SRPT stock update.
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