Sarepta Therapeutics (NASDAQ:SRPT) saw its stock plummet in premarket trading Friday following the disclosure of a patient death linked to one of its gene therapy trials. According to Bloomberg, the incident occurred during an early-stage study targeting limb-girdle muscular dystrophy.
A company spokesperson told Bloomberg that the patient passed away last month due to acute liver failure after receiving an experimental treatment.
Regulatory authorities and clinical investigators were notified “in an appropriate and timely manner,” the spokesperson added, according to the report.
“While we do everything possible to ensure patient safety, there is inherent risk in clinical trials, and we are grateful to the courageous patients and families who participate,” the spokesperson said.
Sarepta’s shares dropped as much as 22% in premarket action. The stock has already lost about 85% over the past year as of Thursday’s close.
The reported death adds to a string of safety concerns for Sarepta. Bloomberg noted that it follows two previous fatalities of teenage boys who suffered acute liver failure while receiving Elevidys, the company’s approved gene therapy for Duchenne muscular dystrophy.
In response to regulatory concerns, Sarepta said Wednesday it will include a liver failure warning on the Elevidys label, as requested by the U.S. Food and Drug Administration.
That same day, the biotech firm also announced major cost-cutting measures, including laying off more than a third of its workforce and halting development on several pipeline programs. These steps are expected to deliver around $400 million in annual savings.
Sarepta Therapeutics stock price
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