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Gene Therapy Developer Sarepta Faces Third Patient Death
UNITED STATES, JUL 18 – Sarepta's third patient death from liver failure linked to gene therapy SRP-9004 raises safety concerns and investor distrust amid halted shipments and regulatory scrutiny.
- On Friday morning, Sarepta Therapeutics confirmed a third patient death linked to its gene therapy programs, involving a 51-year-old man who died in June from acute liver failure after receiving SRP-9004, raising safety concerns.
- Earlier this year, two Elevidys patients died from acute liver failure, prompting strengthened risk mitigation strategies, while SRP-9004 uses an adeno-associated virus vector linked to fatal liver complications.
- Bloomberg reported that all three fatalities were linked to acute liver failure, while in recent weeks Sarepta added a boxed warning to Elevidys and halted shipments for non-ambulatory patients.
- During its restructuring update earlier this week Sarepta omitted the death, drawing scrutiny from analysts, while Sarepta Therapeutics' CEO Doug Ingram avoided safety questions on Wednesday.
- Regulatory scrutiny is intensifying as Marty Makary said the FDA is considering whether the gene therapy should remain on the market, and Sami Corwin warned SRP-9003’s safety could face increased review ahead of its BLA.
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Sarepta CEO: ‘We Have, I Believe, a Very Laudable History of Being Extraordinarily Transparent’
Sarepta Therapeutics knew about the death of a patient treated with its experimental gene therapy for a type of limb-girdle muscular dystrophy, but said nothing public for a month. Financial analysts lambasted Sarepta executives for failing to disclose the fatality when the company announced a restructuring that includes stopping work on this limb-girdle program. The post Sarepta CEO: ‘We Have, I Believe, a Very Laudable History of Being Extraor…
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Total News Sources18
Leaning Left2Leaning Right1Center7Last UpdatedBias Distribution70% Center
Bias Distribution
- 70% of the sources are Center
70% Center
L 20%
C 70%
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