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FDA, Sarepta and Elevidys

FDA Probes Death Of 8-Year-Old Who Received Sarepta's Elevidys

FDA probes Elevidys after an 8-year-old's death in Brazil; Sarepta and Roche say the death was unrelated to gene therapy treatment.

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Sarepta shares soar 36% after FDA clears partial resumption of Elevidys shipments

Sarepta Therapeutics shares jumped over 36% on Tuesday after the company said it had received FDA approval to restart shipments.

Sarepta can begin shipping Elevidys therapy after FDA reverses pause, stock soars

Sarepta ( SRPT) will begin shipping its top-selling muscular dystrophy therapy, Elevidys, after the U.S. Food and Drug Administration (FDA) reversed its request for a voluntary pause late Monday.

STAT breaks down the confusing, heartbreaking Sarepta saga

In the latest episode of STATus Report, Alex Hogan breaks down the confusing, heartbreaking saga of Sarepta and its gene ...

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US FDA recommends removal of hold on Sarepta's Elevidys in some patients

The U.S. Food and Drug Administration said on Monday it is recommending the removal of the hold placed on Sarepta ...

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Sarepta rises 2%; Barclays downgrades to underweight on liquidity and Elevidys concerns

Sarepta Therapeutics (NASDAQ:SRPT) shares dropped sharply premarket on Monday before paring losses as Barclays revised its ...

Sarepta’s Future Increasingly Uncertain as FDA Eyes New Study for Elevidys

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...

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Sarepta Therapeutics Provides Clarifying Statement on ELEVIDYS

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the ...

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