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PTC Therapeutics Withdraws FDA Application for Duchenne Drug Translarna After Decade-Long Effort

Feb 13, 2026

PTC Therapeutics has withdrawn its New Drug Application for Translarna (ataluren) for Duchenne muscular dystrophy after the FDA indicated the data were unlikely to meet approval thresholds, ending a pursuit spanning more than a decade.

PTC Therapeutics Withdraws Ataluren NDA for Duchenne Muscular Dystrophy

Feb 13, 2026

PTC Therapeutics has withdrawn its New Drug Application resubmission for ataluren (Translarna) for nonsense mutation Duchenne muscular dystrophy after the FDA indicated the submission lacked substantial evidence of effectiveness.