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With new data, Regenxbio to seek FDA approval of Duchenne gene therapy
Though two serious side effects muddied the results, CEO Curran Simpson expressed optimism about a clearance and claimed FDA leadership will have a “mandate on rare disease flexibility.”
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biopharmadive.com
With new data, Regenxbio to seek FDA approval of Duchenne gene therapy
Though two serious side effects muddied the results, CEO Curran Simpson expressed optimism about a clearance and claimed FDA leadership will have a “mandate on rare disease…
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statnews.com
Regenxbio says Duchenne gene therapy succeeded in clinical trial, paving way for FDA submission
Regenxbio said its experimental gene therapy for Duchenne muscular dystrophy succeeded in a trial, paving the way for a submission to the FDA.
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endpoints.news
Regenxbio's Duchenne study succeeded. Will it be enough to convince the FDA?
Regenxbio said Thursday that its Duchenne muscular dystrophy gene therapy met the bar in a pivotal study, and it’s aiming for FDA approval in 2027.