Sarepta Elevidys Shipments

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Sarepta halts Elevidys shipments

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GlobalData on MSN · 2d

Sarepta halts Elevidys shipments following FDA pressure

Sarepta CEO Doug Ingram said it is important the company maintains a “positive working relationship” with the FDA.

· 1d · on MSN

Roche pauses shipments of Elevidys gene therapy outside US

BioSpace · 1d

Following Sarepta’s Lead, Roche Suspends Elevidys Shipments to Some Ex-US Countries

· 1d

InnovationRx: Sarepta Blinks In Showdown With FDA

The latest twist in the saga followed a decision by Children’s Hospital Los Angeles to halt use of the drug while it was facing regulatory uncertainty.

· 2d

Sarepta falls after gene therapy maker pauses Elevidys shipments in US

· 2d

Sarepta pares gains as report suggests an ‘arduous’ path for Duchenne drug

4hon 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 gene therapy, Elevidys. Read more here.

Fierce Pharma5h

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 reported Thursday, citing an unnamed senior FDA official.