Sarepta Elevidys FDA Concerns - Search News

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Sarepta Soars

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.

BioPharma Dive · 2d

FDA allows Sarepta to resume some Elevidys shipments

The company can again ship the Duchenne gene therapy for patients who can still walk, following a one-week pause triggered by safety concerns.

The Boston Globe · 1d

Sarepta soars after FDA says some patients can get Elevidys

Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients who can walk be allowed to take its gene therapy Elevidys again.

Fierce Biotech9d

Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy

The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb-girdle ...

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 ...

2don MSN

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 ...

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