News

Sarepta will resume gene therapy shipments after FDA review of recent patient death

Shares of beleaguered drugmaker Sarepta Therapeutics jumped in afterhours trading Monday after the company said it would ...
Fierce Pharma5d

FDA launches probe into new Elevidys death as Sarepta, Roche stress gene therapy not at fault

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

FDA probes death of patient on Sarepta's Elevidys, partner Roche says death unrelated to therapy

The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received ...
BioSpace5d

Sarepta Denies Latest Patient Death is Elevidys-Linked as FDA Launches Probe

Brazilian authorities said the death was unlikely to have been caused by Elevidys and was instead more in line with severe ...

Sarepta denies Elevidys is linked to latest patient death in Brazil

Sarepta Therapeutics (SRPT) in focus as the biotech says the death of a patient who had received its gene therapy Elevidys ...
Fierce Pharma8d

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 ...
The Pharma Letter5d

Patient death in Brazil not related to Elevidys, Sarepta says

The US Food and Drug Administration (FDA) issued a press release late Friday announcing an investigation into the death of an ...

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 ...
GEN - Genetic Engineering and Biotechnology News6d

FDA Probes Death of Brazilian Boy Linked to Sarepta’s Elevidys

The FDA is investigating the death last month of an eight-year-old boy in Brazil who had received Sarepta Therapeutics’ Elevidys® (delandistrogene moxeparvovec-rokl)—though the company and its ...

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 ...
BioSpace14d

Sarepta Craters as FDA Considers Requesting Halt to Elevidys Shipments

The rollercoaster week for Sarepta Therapeutics continued, with shares of the embattled gene therapy-turned-siRNA biotech ...

Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys

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.