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Storia in 3 fonti

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.

Raccontata dabiopharmadive.comstatnews.comendpoints.news

Confronto fonti

3 prospettive sulla stessa storia
AI · summaries
statnews.comStai leggendo1 mesi fa

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.

originale
endpoints.news1 mesi fa

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.

Leggi questa versione → originale
biopharmadive.com1 mesi fa

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.”

Leggi questa versione → originale

Timeline cronologica

  1. giovedì 14 maggio 2026·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…

  2. giovedì 14 maggio 2026·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.

  3. giovedì 14 maggio 2026·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.