With Duchenne decision ahead, FDA's Marks pushes for speedy gene therapy approvals [Yahoo! Finance]
Sarepta Therapeutics, Inc. (SRPT)
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Source: Yahoo! Finance
But he didn't drop any clues on where the agency stands on a coming decision to possibly broaden use of one of them, a Duchenne muscular dystrophy treatment the regulator cleared last year. At a meeting hosted by the patient advocacy group CureDuchenne , Peter Marks, head of the FDA office that reviews gene therapies, said the agency's thinking has changed in recent years to become more patient focused. That mindset has led it to more aggressively look for ways to speed the development of rare disease gene therapies. “Although we're a regulatory agency,” he said, the regulations “have to ultimately serve getting products to patients. So we're trying to focus on the patient, and use that to negotiate the regulations to get there as rapidly as possible.” Those comments build on points Marks has made before. Last year, at a meeting held by a different advocacy group, he advocated for flexibility in reviewing rare disease gene therapies while fighting off criticism about accelerated
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SRPT
Earnings
- 5/1/24 - Beat
SRPT
Sec Filings
- 6/7/24 - Form 8-K
- 6/7/24 - Form SC
- 5/6/24 - Form 4
- SRPT's page on the SEC website