US regulators are investigating the death of an 8-year-old boy in Brazil who received Sarepta Therapeutics Inc.’s Elevidys.

It has been a tumultuous two weeks for Sarepta; however, the FDA reauthorising US shipments of Elevidys will be a welcome ...

This regulatory relief, combined with several other compelling catalysts, creates a pathway for the stock to potentially ...

In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to ...

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

Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...

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

Sarepta Therapeutics Inc. (NASDAQ:SRPT) is one of the most undervalued stocks to buy and hold for 3 years. On July 22, BMO ...

Shares of Sarepta surged Tuesday, a day after the FDA said the company could lift a voluntary pause on shipments of its Elevidys drug, which had been linked to three patient deaths this year. The ...

That's because there has been a string of negative developments over the past several months, including three deaths from liver failure of patients taking Sarepta's DMD drugs - which led to a pause in ...

Shares of beleaguered drugmaker Sarepta Therapeutics jumped in afterhours trading Monday after the company said it would ...

The Food & Drug Administration is investigating the death of an 8‑year‑old following Elevidys gene therapy for Duchenne ...