News

Fierce Pharma3d
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 ...
Southwest Journal14d
Breaking: Second Patient Death Prompts FDA Investigation of Sarepta’s Elevidys Gene Therapy
Second patient death from liver failure after Sarepta's Elevidys gene therapy triggers FDA investigation. Stock crashes 41% ...
FDA to Ask Sarepta to Halt Elevidys Shipments After Deaths
Sarepta Therapeutics Inc. said another patient has died from acute liver failure after receiving one of its gene therapies, putting additional pressure on the biotech company after the recent deaths ...
BioSpace4d
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 ...
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 ...
Sarepta denies Elevidys is linked to latest patient death in Brazil
Shortly after the U.S. FDA announced an investigation into the death of a patient who had received Elevidys, a gene therapy ...
Fierce Pharma3d
FDA takes U-turn on Sarepta's Elevidys, backing Duchenne gene therapy again in ambulatory patients
Monday, the FDA said Sarepta may resume treating ambulatory DMD patients with Elevidys. The recommendation comes just 10 days ...
Fierce Biotech13d
UPDATED: Analysts demand transparency after Sarepta's roundabout disclosure of 3rd patient death
On an investor call Friday, analysts grilled the company over its apparent lack of transparency on the matter.
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 ...
BioSpace14d
Sarepta Reports a Third Gene-Therapy Related Patient Death
The patient, who was being treated with an investigational gene therapy for limb-girdle muscular dystrophy, died of acute ...
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 ...
Sarepta plunges after third patient death tied to gene therapy - report
Sarepta Therapeutics (SRPT) said a third patient has died from acute liver failure after receiving one of its gene therapies, intensifying scrutiny over the safety of its treatments, Bloomberg ...